COVID-19 Weekly Update
Editor’s note: This page is updated weekly with new information related to COVID-19 testing and potential treatments in development. Click the arrow next to the date to view previous entries. With FDA authorization of the first vaccine to prevent COVID-19, the Dec. 16 entry will be the last in this series.
Dec. 16: Pfizer vaccine approved in US; vaccinations begin
The U.S. Food and Drug Administration granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine on Dec. 11, the first such approval in the U.S. It is indicated for the prevention of COVID-19 in individuals ages 16 and older, and administered in a series of two doses three to four weeks apart. Although approval was given with backing from an FDA advisory committee, some members of the panel expressed concern regarding a lack of available data for patients, ages 16 and 17. The vaccine showed a 95% efficacy rate in a Phase 3 trial (NCT04368728).
Pfizer shipped 2.9 million doses of the vaccine across the country over the weekend via cold-chain shipping, which was used to keep the vaccines at the required temperature of -94 F. The second round of shots, another 2.9 million, will be shipped at a later date.
Vaccinations began Monday, with 145 sites expected to receive the vaccines, with another 425 receiving them Tuesday, and the remaining 66 sites on Wednesday. Frontline healthcare workers and seniors are first in line to receive the vaccine.
Hackers access Pfizer regulatory documents
Hackers accessed information related to Pfizer and BioNTech’s COVID-19 vaccine regulatory submission for emergency use in Europe, the companies have disclosed. BioNTech reported that as far as the company is aware, no study participants were identified through the breach. According to the European Medicines Agency, the incident will have no effect on the timeline for review. The regulatory agency is meeting Dec. 21 to assess the vaccine; a decision on approval in the EU is anticipated before Christmas.
FDA authorizes 1st at-home COVID-19 tests
LabCorp received the first FDA emergency use authorization for an at-home COVID-19 test kit, in which individuals can self-collect a sample via nasal swab and send it to a laboratory for testing. The Pixel COVID-19 Test Home Collection Kit is available without a prescription for people ages 18 and older and can be purchased online or in a store.
The FDA also granted emergency use authorization to the first over-the-counter, fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is designed to detect fragments of the SARS-CoV-2 virus by samples collected via nasal swab; results are available in as little as 20 minutes and don’t require lab testing. The kit is indicated for people ages 2 and older, with or without symptoms.
Quest Diagnostics also received emergency use authorization for its combination COVID-19 and flu test. The test is available by prescription; people can collect samples at home and then ship them to a laboratory for testing. Quest says it intends to make the test available to healthcare providers and employers who want an option for combined COVID-19/flu testing.
Moderna begins dosing adolescents in vaccine trial
Moderna began dosing adolescents, ages 12 to 17, in a Phase 2/3 trial (NCT04649151) of its vaccine candidate, mRNA-1273. The study aims to enroll 3,000 volunteers in the U.S. The vaccine consists of two doses given 28 days apart. Moderna will monitor participants for 12 months after they receive the second dose and plans to have data available in spring to support the vaccine’s use ahead of the 2021 school year. An FDA advisory panel is meeting Thursday to discuss the vaccine; a decision on emergency use authorization is likely to come soon thereafter.
COVID-19 fecal test developed
The FDA announced that it has developed a fecal test to check for SARS-CoV-2 before fecal transplantation procedures. The procedure, formally known as fecal microbiota transplantation, is used to deliver bacteria from the gut of a healthy individual to a patient with an intestinal disease or infection.
► Dec. 9, 2020
Pfizer vaccine approved in UK; first person vaccinated
The U.K. Medicines and Healthcare Products Regulatory Authority has become the first in the world to approve . The temporary authorization for emergency use was done under a rolling review, which allowed the agency to review the scientific data as it became available to shorten the decision time. The companies are immediately beginning the delivery of 20 million vaccine courses preordered by U.K. government preordered. This also marks the first approval of an RNA-based medicine in humans.
Just six days after the approval was announced, Margaret Keenan, a 90-year-old U.K. citizen became the first person to receive the COVID-19 vaccine outside a clinical trial. The U.K. will begin vaccinating front-line healthcare workers, long-term care facility workers, and residents over age 80 first.
Organized crime groups a threat to vaccine supply, agencies warn
and the have both warned that organized criminal groups are targeting COVID-19 vaccine suppliers, seeking to acquire the vaccines themselves and otherwise disrupt supply lines. These threats exist both physically and online. Interpol also warns of criminal efforts to advertise, sell, and administer fake vaccines, and advises the public to be cautious when searching for COVID-19-related products online. IBM’s X-Force commercial security research team also targeted email phishing attempts made against biomedical companies pursuing vaccines.
Moderna launching trial of vaccine candidate in adolescents
NCT04649151) testing its COVID-19 vaccine candidate among adolescents ages 12 to 17 in the U.S. Although there is not yet a date to begin enrolling, the company intends to recruit approximately 3,000 participants across seven sites. The study will evaluate the vaccine’s safety, efficacy, and — the reactions that occur shortly after vaccination. The company recently requested emergency use authorization from the U.S. Food and Drug Administration for the experimental vaccine.a Phase 2/3 trial (
Lilly, UnitedHealth Group studying effectiveness of bamlanivimab
Eli Lilly and UnitedHealth Group arethe effectiveness of the antibody bamlanivimab (formerly LY-CoV555) in a real-world setting. The treatment by the FDA for patients with mild to moderate COVID-19 who are at high risk of severe illness or hospitalization. Qualified UnitedHealthcare Medicare Advantage members will be asked to track their experience with the medication via an app.
The U.S. government spent $812.5 million of bamlanivimab, adding to a previous 300,000 vial order. The government, through the Department of Health and Human Services, will allocate doses through Jan. 31, 2021, based on confirmed COVID-19 cases in each state.
► Dec. 2, 2020
AstraZeneca vaccine candidate questioned after puzzling trial results
AstraZenecaafter reporting a 90% efficacy rate for a one-and-a-half dose vaccine regimen that the company admitted was given by mistake. The full double-dose regimen showed a 62% efficacy. The reasons for the difference in outcomes between the two regimens remains unclear. The company now plans to launch a new global trial to further compare the two dosing regimens and to add the one-and-a-half dose regimen to the ongoing U.S. trial. This could delay plans to apply for emergency use authorization in the U.S.
Moderna requests emergency use authorization for vaccine candidate
Moderna for emergency use authorization to the U.S. Food and Drug Administration for its COVID-19 vaccine candidate, known as mRNA-1273. This is the second EUA request for a vaccine, following Pfizer and BioNTech’s joint request last week. The FDA advisory committee meets Dec. 10 to discuss that vaccine and on Dec. 17 to discuss mRNA-1273. Moderna’s request for authorization is based on the Phase 3 COVE trial (NCT04470427), which showed that the experimental vaccine was 94% effective against COVID-19. At the same time, Moderna also requested conditional marketing authorization from the European Medicines Agency for mRNA-1273 and has started the rolling review process with several other international regulatory agencies.
FDA cracks down on companies selling unproven COVID-19 products
The FDA to companies for at least 1,200 “fraudulent and unproven medical products related to COVID-19,” as of mid-November under its Operation Quack Hack initiative. Among the latest, the agency issued a warning letter to Avazo-Healthcare for selling altered and misbranded test kits and unapproved therapeutic products. The FDA has requested the company immediately stop selling these unauthorized products. Other companies that recently received warning letters include ChromaDex; Innovative Medicine; Red Moon Herbs; and Sage Woman Herbs.
UK trial adds colchicine to list of therapies being tested
The U.K.-based trial the anti-inflammatory medication colchicine to its list of therapies being tested to treat COVID-19. Researchers anticipate randomizing at least 2,500 trial participants to receive colchicine in addition to standard care. Outcomes being measured include mortality, length of hospital stays, and need for ventilation. The RECOVERY trial is aimed at identifying COVID-19 treatments among already-approved therapies. Colchicine is often prescribed for the treatment of gout and may help alleviate lung inflammation seen in COVID-19 patients who need mechanical ventilation.
1st mass shipment of Pfizer vaccine sent to Belgium
The U.S. Federal Aviation Administration of Pfizer’s COVID-19 vaccine candidate was recently sent from Belgium to the U.S. The FAA is prioritizing cargo flights to help transport large quantities of dry ice needed to ship the vaccine, which must be stored at -70 C (-94 F). Pfizer expects to have enough supply to vaccinate up to 25 million people by year’s end. The vaccine cannot be distributed until it is authorized, but emergency use authorization from the FDA is anticipated by mid-December.
► Nov. 25, 2020
AstraZeneca vaccine candidate shows promise
An interim analysis of AZD1222, the COVID-19 vaccine candidate being developed by AstraZeneca and the University of Oxford, met its primary goal, finding the vaccine to be 70% effective in preventing the disease, on average. The vaccine was 90% effective when given as a half-dose followed one month later by a full dose, and 62% effective when given as two full doses one month apart. The pooled analysis included data from a Phase 2/3 trial in the U.K. and a Phase 3 trial in Brazil. AstraZeneca is now planning regulatory submissions around the world and will also seek emergency use listing from the World Health Organization.
Regeneron therapy authorized for emergency use in U.S.
The U.S. Food and Drug Administration has granted Regeneron’s casirivimab/imdevimab antibody cocktail (formerly known as REGN-COV2) emergency use authorization to treat COVID-19 patients, ages 12 and older, with mild to moderate disease who are at risk of progressing to severe disease and/or hospitalization. The authorization is based on an analysis from Phase 1 and 2 trial data (NCT04425629).
Regeneron and Roche have partnered to boost the medicine’s production and expect to have enough supply to treat 300,000 patients in the U.S. by the end of January 2021. Under the U.S. government’s Operation Warp Speed, these initial doses are expected to be given free of charge, although healthcare facilities may charge fees related to administering the therapy. State health departments will manage distribution to hospitals and outpatient clinics.
WHO discourages use of Veklury for COVID-19
The World Health Organization is recommending against the use of Veklury (remdesivir) for hospitalized COVID-19 patients due to a lack of evidence on its effectiveness. An expert panel determined that currently available data show Veklury has little effect on patient outcomes, including mortality, need for ventilation, and time to clinical improvement. An open letter from the chief medical officer of Gilead Sciences, the treatment’s maker, published in late October, disputes the findings of the WHO’s Solidarity trial, on which the panel’s opinion is based. The FDA approved the therapy for use in hospitalized COVID-19 patients last month.
2nd Lilly therapy granted FDA emergency use authorization
The FDA granted emergency use authorization for baricitinib, Eli Lilly’s rheumatoid arthritis medication (approved under the name Olumiant), in combination with Veklury to treat COVID-19 patients requiring supplemental oxygen. The EUA is based on data from a Phase 3 trial (NCT04401579), which showed that the combination therapy reduced recovery time by 12.5% — or from eight days to seven — compared with Veklury alone. The randomized trial is testing the combination therapy compared with a placebo, plus Veklury, in hospitalized COVID-19 patients. Earlier this month, Lilly also received emergency use authorization for bamlanivimab to treat recently diagnosed COVID-19 patients.
Pfizer, BioNTech request emergency use authorization for vaccine candidate
Pfizer and BioNTech are requesting emergency use authorization from the FDA for BNT162b2, their COVID-19 vaccine candidate. The submission comes a day after the companies released data showing their vaccine to be 95% effective at preventing COVID-19. The U.K. Medicines and Healthcare products Regulatory Agency is also currently reviewing an application for the vaccine candidate and may make a decision as early as this week. The companies also began rolling submissions in Europe, Australia, Canada, and Japan, and plan to submit applications to other regulatory agencies around the world.
Roche therapy shows potential in critically ill COVID-19 patients
Roche’s tocilizumab, prescribed for rheumatoid arthritis under the brand name Actemra, reduced mortality and improved outcomes in critically ill COVID-19 patients, according to data from a Phase 4 trial called REMAP-CAP (NCT02735707). The randomized trial, being led by Imperial College London and the Intensive Care National Audit & Research Centre in the U.K. and Utrecht University in Europe, is testing a variety of immunosuppressive therapies to treat the virus. Early results show that Actemra had a 99.75% efficacy in the 303 participants who were randomly assigned to receive the treatment during the trial.
► Nov. 18, 2020
Moderna vaccine shows 94.5% efficacy in interim analysis
An interim analysis of mRNA-1273, Moderna’s COVID-19 vaccine candidate, indicated a 94.5% efficacy rate. The analysis was based on 95 confirmed COVID-19 cases, 90 of whom received placebo and five who received the mRNA-based vaccine in the randomized Phase 3 COVE trial (NCT04470427). No significant safety concerns were reported.
Moderna plans to submit the data to a peer-reviewed publication and to apply for emergency use authorization, which the company says will include the two months of safety data required by the U.S. Food and Drug Administration. The European Medicines Agency has started a rolling review of the vaccine, a process that will continue until enough data is collected to support a marketing authorization application.
In a separate announcement, Moderna says its vaccine remains stable for up to 30 days at temperatures between 2 and 8 C (36–46 F). This makes it easier to store in pharmacies and doctors’ offices. It can also be stored for up to six months at -20 C, roughly the temperature of a home freezer, making it easier to ship to regions with poor infrastructure.
CureVac vaccine shows promising stability profile
German-based pharmaceutical company CureVac reports that its mRNA-based vaccine candidate, CVnCoV, remains stable for at least three months at 5 C (41 F), reducing distribution challenges. It also remains stable for up to 24 hours at room temperature. The experimental vaccine is currently being evaluated in a Phase 2a trial (NCT04515147) in Peru and Panama.
Interim results from a Phase 1 trial (NCT04449276), which tested CVnCoV given in two doses 28 days apart, showed that it was safe and well tolerated. The 12-microgram dose induced the most promising immune response and will be tested further in a Phase 2b/3 trial the company plans to begin before the end of the year.
CureVac is also scaling up its manufacturing capacity in Europe, with plans to supply up to 300 million doses of CVnCoV next year and up to 600 million doses in 2022.
Antidepressant Luvox may help COVID-19 respiratory symptoms
Antidepressant Luvox (fluvoxamine) may halt the progression of respiratory symptoms in COVID-19 patients with breathing problems, according to results from a randomized Phase 2 trial (NCT04342663). Luvox is typically prescribed for depression, social anxiety or obsessive-compulsive disorders, and also has anti-inflammatory properties.
The study included 152 participants with symptomatic COVID-19 who were randomly assigned to receive either Luvox or a placebo over a 15-day treatment period in an outpatient setting. None of the 80 participants given Luvox saw an increase in breathing difficulties, while six of the 72 participants who received the placebo did. The results indicate that Luvox may be able to lower the risk of hospitalization.
The COVID-19 Early Treatment Fund provided funding for the trial and is now funding a larger trial in 880 participants to confirm the findings, according to a press release.
J&J testing two-dose regimen of vaccine candidate
Johnson & Johnson has begun a second global Phase 3 trial, called ENSEMBLE 2 (NCT04614948), which is evaluating a two-dose regimen of its COVID-19 vaccine candidate JNJ-78436735. The trial, which will recruit up to 30,000 participants, will run in parallel with the ENSEMBLE study (NCT04505722), which is testing a single dose of the vaccine.
Although interim data from a Phase 1/2a trial showed that the single dose induced a robust immune response, the company says it is investigating multiple doses and dosing regimens in an effort to be extremely thorough in finding the most effective solution.
Inovio cleared to begin Phase 2 portion of trial testing potential vaccine
The FDA cleared Inovio to begin the Phase 2 portion of a randomized Phase 2/3 trial called INNOVATE, evaluating the safety, tolerability, and ability to induce an immune response of a two-dose regimen of INO-4800, its potential COVID-19 vaccine, compared with a placebo. Funded by the Department of Defense, this phase of the trial will enroll approximately 400 participants across 17 U.S. sites.
The Phase 3 segment remains on partial clinical hold while the company resolves the FDA’s questions related to the device that will be used to deliver INO-4800 directly into patients’ skin. The remaining questions will be resolved during the Phase 2 portion, according to the company.
► Nov. 11, 2020
Pfizer, BioNTech vaccine candidate shows promise
Pfizer and BioNTech’s experimental mRNA-based vaccine was found to be more than 90% effective in preventing COVID-19 in individuals without evidence of prior SARS-CoV-2 infection, according to early results from a global Phase 3 trial (NCT04368728). The analysis is based on results from 94 confirmed COVID-19 cases among the nearly 44,000 enrolled participants. No safety concerns were identified. The companies plan to submit an application for emergency use authorization for the vaccine to the U.S. Food and Drug Administration around the third week of November, after they have acquired the necessary two months’ worth of safety data. The trial will continue until it reaches 164 confirmed COVID-19 cases for further data analysis.
Brazil pauses CoronaVac Phase 3 trial due to serious adverse event
Brazil’s regulatory health agency has halted a Phase 3 trial testing Sinovac’s vaccine candidate CoronaVac, citing a serious adverse event, reportedly resulting in the death of a participant. According to a statement issued by Sinovac in response to media reports, the head of Instituto Butantan, which is assisting with the trial, does not believe the adverse event is related to the vaccine. Regulators are investigating the death and reviewing trial data to determine when and if it may be safe to restart the trial. Preliminary results from a Phase 1/2 trial of CoronaVac were promising, showing a positive safety profile and a more than 90% immune response rate among trial participants.
FDA emergency use authorization granted for Lilly treatment
The FDA has issued emergency use authorization for Eli Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555). The medication is authorized for treating mild to moderate cases of COVID-19 in recently diagnosed patients, ages 12 and older, who have a high risk of progressing to severe disease and/or hospitalization. The decision is based on data from a randomized Phase 2 trial called BLAZE-1 (NCT04427501), which is continuing to evaluate bamlanivimab’s safety and effectiveness. Results so far have shown that the treatment has been able to lower viral load, symptoms, and hospitalization rates, compared with a placebo, among high-risk patients.
Novartis’ Ilaris fails to meet goals in Phase 3 trial
Interim results from a randomized Phase 3 trial called CAN-COVID (NCT04362813) found that Novartis’ Ilaris (canakinumab) did not increase the chances of patient survival without the need for mechanical ventilation, nor did it reduce mortality, compared with standard treatments. The trial tested the therapy in 454 COVID-19 patients with pneumonia and cytokine release syndrome, a systemic inflammatory condition. Interim data were analyzed at 29 days after treatment administration; the trial is ongoing, with full results expected in early 2021.
Regeneron experimental treatment shows benefits in Phase 2/3 trial
Regeneron’s antibody cocktail, REGN-CoV2, significantly lowered the viral load and need for medical visits in patients with confirmed COVID-19, according to results from a Phase 2/3 trial. Data were analyzed from 799 patients enrolled in the randomized trial, which is evaluating the effect of REGN-CoV2 added to standard care, compared with a placebo plus standard care. Results indicated that the experimental therapy was most effective in those who were considered at high risk of poorer outcomes because they had not mounted an effective immune response to the virus prior to treatment. Regeneron has submitted the results to the FDA as part of its application for emergency use authorization.
FDA gives emergency use authorization to antibody blood test
The FDA has granted emergency use authorization to GenScript USA for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit. The kit is the first authorized blood test for detecting antibodies from a previous COVID-19 infection, which indicate that an individual has developed an adaptive immune response to the virus. It is intended for research use only and is not meant to identify those with a current infection.
Bangladesh inks agreement for supply of AstraZeneca vaccine candidate
The government of Bangladesh signed a supply deal with the Serum Institute of India for 30 million doses of AstraZeneca’s experimental COVID-19 vaccine, AZD1222. This will amount to vaccines for 15 million people, as each vaccination consists of two doses given 28 days apart. The cost is expected to be the same as in India, amounting to a few dollars per dose.
► Nov. 4, 2020
India’s regulatory agency has denied Dr. Reddy’s Laboratories’ request for approval of remdesivir for treating COVID-19, limiting it to restricted emergency use within the country. Remdesivir recently became the first treatment to be approved (under the brand name Veklury) for COVID-19 by the U.S. Food and Drug Administration. However, recently published results from the World Health Organization’s Solidarity trial showed the therapy had little to no effect on mortality, need for ventilation, or length of hospital stays in COVID-19 patients.
The U.S. government will require most private health plans to cover FDA-approved COVID-19 vaccines and their administration at no cost to consumers, once a vaccine becomes available. Medicare will also provide the vaccine at no cost to participants, and Medicaid will provide the vaccine with no cost-sharing to most beneficiaries. The government will reimburse providers that administer the vaccine to those with no insurance.
Regeneron has temporarily stopped enrolling patients needing high-flow oxygen or mechanical ventilation in its Phase 3 trial testing the antibody cocktail REGN-CoV2 against COVID-19. The decision followed a recommendation made by an independent data monitoring committee, which identified a “potential safety signal and an unfavorable risk/benefit profile” related to the treatment. The company will continue enrolling hospitalized patients requiring no or low-flow oxygen.
Algernon Pharmaceuticals plans to begin a Phase 3 study investigating the potential benefit of NP-120 (ifenprodil) in treating COVID-19. The goal is to determine whether NP-120 improves blood oxygen levels and reduces both mortality and time spent in an intensive care unit. Study participants will receive either standard care, standard care plus 60 mg of NP-120, or standard care plus 120 mg of NP-120.
Novavax will expand its Gaithersburg, Maryland, facility to increase capacity to develop and manufacture its COVID-19 and influenza vaccines. The company’s COVID-19 vaccine candidate, NVX-CoV2373, is currently in late-stage global studies. Additional trials are expected to begin in the U.S. and Mexico this month. Novavax is also looking into a combined influenza/COVID-19 vaccine for post-pandemic use.
► Oct. 28, 2020
The U.S. Food and Drug Administration approved remdesivir under the brand name Veklury for the treatment of hospitalized adults and children with COVID-19, ages 12 and older, weighing at least 88 pounds. The FDA had granted the antiviral medication emergency use authorization in May, which it has now revised to cover pediatric patients younger than 12 and weighing less than 88 pounds. Veklury is the first medicine to win full approval for the treatment of COVID-19.
At the same time, the World Health Organization plans to release new treatment guidelines for Veklury, following a review of multiple clinical trials that found no clinical benefit or improvement in survival outcomes for COVID-19 patients treated with Veklury. The WHO will convene an expert panel this week to review all available evidence for the therapy’s effectiveness.
Eli Lilly has permanently halted the Phase 3 ACTIV-3 trial (NCT04501978) testing its investigational antibody bamlanivimab (LY-CoV555) in combination with Veklury for the treatment of the COVID-19. Last week, the trial was paused to allow an independent data safety monitoring board to evaluate a potential safety issue. The decision to stop the trial was based on data that indicated that bamlanivimab would not help hospitalized patients in the advanced stages of the illness. All other trials assessing bamlanivimab in different settings will continue, according to the company.
Lilly also recently announced an agreement with the U.S. government to supply 300,000 vials of bamlanivimab for $375 million, if the FDA grants the emergency use authorization submitted earlier this month. The government also has the option to purchase an additional 650,000 vials by the end of June 2021.
The British government has authorized human challenge trials to advance the development of a COVID-19 vaccine. The trial will enroll up to 90 paid participants, ages 18 to 30, who will be given doses of SARS-CoV-2 to determine the smallest amount of virus capable of triggering a COVID-19 infection. The government has not specified which candidates are being tested, although trials may begin as early as January, with results anticipated by May 2021.
Moderna has completed enrollment in the Phase 3 COVE trial (NCT04470427) testing mRNA-1273, its COVID-19 vaccine candidate. The trial now includes 30,000 participants at multiple sites across the U.S. According to the company, more than 25,650 participants have already received their second vaccination. The randomized study is evaluating a 100 microgram dose of the vaccine for the prevention of symptomatic COVID-19. Moderna will determine whether to submit an application to the FDA for emergency use authorization once the required two months of safety data are obtained.
CureVac’s COVID-19 vaccine candidate CVnCoV has shown promising preclinical results in mice and hamsters. The mRNA-based vaccine triggered a balanced immune response with a favorable safety profile. The experimental vaccine is currently in Phase 1 (NCT04449276) and Phase 2a (NCT04515147) trials. CureVac hopes to announce interim Phase 1 data shortly.
Canada has made $163 million available to advance the development of a domestically produced COVID-19 vaccine, Prime Minister Justin Trudeau recently announced at a news conference. Medicago, based in Québec City, plans to begin Phase 2 trials of its plant-based vaccine in November and hopes to begin Phase 3 trials in December. The company could potentially supply 76 million doses of the vaccine.
► Oct. 21, 2020
Enrollment in a Phase 3 trial (NCT04501978) testing Eli Lilly’s investigational neutralizing antibody has been paused on the recommendation of an independent data safety monitoring board. The randomized ACTIV-3 trial is evaluating the efficacy of bamlanivimab (LY-CoV555), in combination with remdesivir, in hospitalized COVID-19 patients at multiple sites in the U.S., Denmark, and Singapore. No reason has been given yet for the hold, but, according to the company, the board is currently reviewing trial data to ensure the safety of the participants.
Pfizer got the go-ahead from the U.S. Food and Drug Administration to include participants as young as 12 in its global Phase 3 trial (NCT04368728) of its COVID-19 vaccine candidate. The move follows a letter from the American Academy of Pediatricians that urged the inclusion of younger people in these trials to better understand the effects of COVID-19 vaccines in different age groups. Pfizer is developing the mRNA vaccine candidate with partner BioNTech. The randomized trial is recruiting an estimated 44,000 healthy volunteers at 175 sites around the world.
Pfizer may know whether its experimental COVID-19 vaccine is effective by the end of October, but will not apply for emergency use authorization until the required safety results have been evaluated, the company’s CEO Albert Bourla said in an open letter. Assuming the fastest possible outcome, the EUA application would not occur before the third week of November. The FDA requires two months of safety data on half of the trial participants, following the final dose of a potential vaccine.
The World Bank approved $12 billion to help developing countries purchase COVID-19 vaccines, tests, and treatments. The financing forms part of the organization’s $160 billion health plan to assist more than 100 countries during the pandemic through 2021. In addition, the International Finance Corporation, the World Bank’s private sector arm, has committed $4 billion to help ramp up the production of COVID-19 vaccines and therapies, and ensure access to them.
Four repurposed drugs — remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon — have limited or no effect on death rate, need for ventilation, and length of hospital stays of COVID-19 patients, according to final results from a Phase 3 international trial (NCT04315948). The largest randomized study of its kind in the world, the World Health Organization’s Solidarity trial tested the therapies in more than 11,000 participants in over 30 countries. In light of these recent results, newer antiviral treatments, immunomodulators, and monoclonal antibodies are now being considered for evaluation.
Fujifilm has asked the Japanese Ministry of Health, Labour and Welfare to approve its influenza medication Avigan (favipiravir) for the treatment of COVID-19. The request is based on the results of a Phase 3 trial in 156 COVID-19 patients with non-severe pneumonia, which showed that those taking Avigan improved in 11.9 days, on average, compared with 14.6 days for those on a placebo. According to the company, it has been working to increase production of the therapy both in and outside of Japan to ensure adequate supply.
In an agreement with the U.S. government, CVS and Walgreens will provide and administer COVID-19 vaccines to residents of long-term care facilities in the U.S. with no out-of-pocket costs. The Pharmacy Partnership for Long-Term Care Program is part of Operation Warp Speed, a government initiative to speed up access to coronavirus vaccines. Although no vaccines have been approved yet, the program has been set up in anticipation of a vaccine being available by the end of the year.
► Oct. 14, 2020
Johnson & Johnson has paused dosing in all of its COVID-19 vaccine trials following an unexplained illness in one patient. The company could not say whether that patient had received the experimental vaccine or a placebo. An independent data and safety monitoring board is reviewing the case to determine the circumstances and when the trials may be able to resume. Clinical trial pauses are not uncommon but are receiving greater attention now, due to the heightened focus on potential vaccines against the virus.
The National Institutes of Health has begun enrolling symptomatic COVID-19 patients for its Phase 3 ITAC trial (NCT04546581). The study will test the safety, tolerability, and effectiveness of a combination of the antiviral remdesivir, plus an antibody solution called anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG), produced by Takeda and CSL Behring. Taking place at 58 sites worldwide, the trial is recruiting approximately 500 hospitalized patients who have had COVID-19 symptoms for 12 days or less. Participants will be randomly assigned to receive either the combination treatment or a placebo, plus remdesivir.
Eli Lilly plans to seek emergency use authorization from the U.S. Food and Drug Administration for LY-CoV555, the company’s experimental combination therapy, in higher-risk COVID-19 patients. The company also anticipates requesting an EUA for a combination therapy of LY-CoV555 and LY-CoV016 in November and filing for standard approval possibly in early 2021. Interim data from the Phase 2 BLAZE-1 trial (NCT04427501) showed the therapy decreased viral loads, symptoms, and COVID-19-related hospitalizations.
Regeneron has asked the FDA for an EUA for its experimental COVID-19 treatment, REGN-CoV2. The double antibody combination is used to treat patients with mild symptoms and high viral loads, but who have not yet mounted an immune response. The company was awarded a $450 million contract in July to manufacture and supply the therapy, upon approval, under the government’s Operation Warp Speed program. REGN-CoV2 is currently being evaluated in several late-stage trials.
Moderna says it will not enforce any patents related to its COVID-19 vaccine candidate for the duration of the pandemic in an effort to end the crisis as quickly as possible. In addition, the company said it is willing to license intellectual property rights to others for use after the pandemic ends. The company has filed several patents related to its experimental mRNA-1273 vaccine, which is now being tested in a Phase 3 trial (NCT04470427).
Hengenix Biotech is preparing to launch an early-stage clinical trial to test the safety and pharmacokinetics (movement in the body) of HLX70, a monoclonal antibody against COVID-19, among healthy volunteers. Hengenix is owned by China-based Fosun Pharmaceutical, which recently gained FDA approval to conduct human testing of the antibody in the U.S.
► Oct. 7, 2020
The National Institute of Allergy and Infectious Diseases has stopped enrolling severely ill COVID-19 patients into a Phase 3 trial (NCT04492475) testing Merck’s Rebif (interferon beta-1a) with Gilead Sciences’ remdesivir due to safety concerns. An internal review determined that patients on high-flow oxygen/non-invasive mechanical ventilation who received Rebif were experiencing more adverse events than those not taking the medicine. The trial will continue to enroll less severe cases, such as patients on low-flow oxygen and those not requiring supplemental oxygen as there were no safety issues among these patients.
CureVac has begun a Phase 2 dose-confirmation trial (NCT04515147) of its COVID-19 vaccine candidate CVnCoV in Panama and Peru. The study will recruit roughly 690 healthy volunteers in two age groups: 18–60 years old; and 61 and older. Participants will receive two vaccinations 28 days apart, and the safety and efficacy of CVnCoV will be evaluated at different doses, starting at 6 micrograms. CureVac hopes to begin a late-stage global trial with 30,000 participants later this year.
The European Medicines Agency began a rolling review of AZD1222, a COVID-19 vaccine candidate being developed by AstraZeneca and the University of Oxford. The review is based on earlier results showing that the vaccine candidate triggers the production of antibodies against the virus. Following a brief pause due to an adverse event in one U.K. participant, trials testing the vaccine candidate have now resumed in the U.K., Japan, Brazil, South Africa, and India. The company continues to work with the U.S. Food and Drug Administration (FDA) on resuming the trial in the U.S.
Moderna says it will not be ready to submit a request for emergency use authorization (EUA) from the FDA for its vaccine candidate mRNA-1273 before Nov. 25, at the earliest. If approved, the vaccine could become available sometime during the first half of 2021. The company had previously suggested it could file for an EUA by Nov. 1. The vaccine is currently being tested in a Phase 3 trial (NCT04470427) in the U.S.; the randomized trial is still recruiting up to 30,000 volunteers.
The White House has now approved the FDA’s stricter criteria for early COVID-19 vaccine approval after it was previously reported that it was blocking the proposed set of guidelines. The new recommendations will be included in the preparatory materials needed for an advisory panel meeting with the agency. They include a median of two months’ follow-up data from patients in late-stage clinical trials.
The FDA sent a warning letter to Texas-based KetoKerri for selling unapproved COVID-19 treatments. KetoKerri had made false and misleading statements regarding its supplements, including advice that customers drink “a mixture of chlorine dioxide and water for the prevention and treatment of COVID-19, among other diseases.” Chlorine dioxide is not an effective treatment and can cause serious side effects, the agency warned.
Gilead Sciences reassumed distribution of its investigational COVID-19 treatment Veklury (remdesivir) in the U.S. from the federal government. The government had controlled the distribution of Veklury while the medication was scarce, but the company has since increased manufacturing and demand has declined, making government control unnecessary. Meanwhile, the U.K. government has now limited the supply of Veklury, prioritizing it for those with severe infections who need it most. According to the health ministry, the current supply is sufficient, but precautions are being taken due to a recent increase in hospitalizations. The treatment is authorized for use in both countries for COVID-19 but not yet approved.
► Sept. 30, 2020
The U.S. Food and Drug Administration (FDA) Inovio Pharmaceuticals’ planned Phase 2/3 trial testing its COVID-19 vaccine candidate INO-4800. In particular, the FDA is asking for more information about Cellectra 2000, the device that would be used to deliver the vaccine. According to Inovio, the hold was not due to any adverse reactions related to its Phase 1 trial (NCT04336410) of INO-4800. The company says it is planning to submit a response to the FDA in October, and the agency will make a decision on whether the trial can proceed within 30 days after receiving the response.on
The NCT04376684) testing otilimab, an investigational rheumatoid arthritis treatment, for treating hospitalized COVID-19 patients. The trial will evaluate otilimab’s ability to reduce the effects of COVID-19 in the lungs. Patients will be randomized to receive either a single hourlong infusion of otilimab or a placebo, plus standard care. The trial is enrolling an estimated 800 hospitalized patients who are receiving oxygen or are on ventilator support. The primary measure is the proportion of patients who are alive and free of respiratory failure 28 days after receiving the therapy.in GlaxoSmithKline’s (
Novavax of its COVID-19 vaccine candidate NVX-CoV2373 in the U.K. The company expects to enroll 10,000 volunteers ages 18–84 over the next four to six weeks. The trial will randomize participants to receive either the vaccine candidate or a placebo, which will be given as two doses, spaced three weeks apart. Novavax is already evaluating NVX-CoV2373 in two ongoing trials in South Africa (NCT04533399), and in the U.S. and Australia (NCT04368988).
Johnson & Johnson has the largest COVID-19 vaccine trial (NCT04505722) to date. The multi-country Phase 3 ENSEMBLE trial will test the safety and efficacy of Ad26.COV2.S in preventing COVID-19 in 60,000 volunteers. The vaccine candidate will be given as a single shot, the effects of which will be compared with that of a placebo. The trial follows positive results from a Phase 1/2a trial of Ad26.COV2.S, which demonstrated sufficient safety and immune response. Johnson & Johnson joins other companies in publishing the Phase 3 study’s to aid transparency. The trial is currently recruiting participants at 291 locations around the world.
Relief Therapeutics and NeuroRx to the FDA for emergency use authorization for RLF-100 (aviptadil) to treat COVID-19 patients with respiratory failure. The authorization is intended to cover those who are in intensive care and have exhausted all approved treatment options. The application is based on a single-center case-controlled study in 51 patients, in which those treated with RLF-100 showed a threefold increase in survival, recovery from respiratory failure, and improvement in other clinical measures, compared with those on standard care.
► Sept. 23, 2020
Sinovac has begun a Phase 3 trial for its COVID-19 vaccine candidate, called CoronaVac, in Turkey. The first part of the randomized trial will test the safety and efficacy of the experimental vaccine in 1,300 healthcare workers. The second part of the trial will include 12,000 volunteers from the general population. Participants in both parts will be randomly assigned to receive either one of two doses of the vaccine or a placebo. In Phase 1/2 trials conducted in China, CoronaVac seemed to be well-tolerated at different doses, with a favorable immune response and no serious side effects.
The German government is looking to boost its COVID-19 vaccine development efforts with grants of 375 million euros ($439 million) to BioNTech and 252 million euros ($295 million) to CureVac. Funding will support the clinical development and mass production of these companies’ messenger RNA (mRNA)-based vaccine candidates. BioNTech’s experimental vaccine, which it is developing in collaboration with Pfizer, is currently in Phase 3 trials, with results expected in October. CureVac’s candidate is in Phase 1 trials, with data expected by the end of the year.
Ly-CoV555, Eli Lilly’s COVID-19 vaccine candidate, lowered the rate of hospitalization among patients with a recent diagnosis of mild to moderate COVID-19, according to Phase 2 interim results announced by the company. The randomized Phase 2 BLAZE-1 trial (NCT04427501) tested three doses — 700 mg, 2,800 mg, and 7,000 mg — compared with a placebo. The trial met its primary goal, change in viral load from the study’s start to day 11, only at the 2,800 mg dose. The trial is ongoing, now testing LyCoV555 in combination with another Lilly antibody called LY-CoV016.
Moderna, Pfizer, and AstraZeneca have made public their vaccine trial study plans. While these plans are typically not revealed until studies are completed, all three companies are taking steps to ensure transparency. The documents include all the details of the trials, including their design, rationale, participants and eligibility, timetable, and how the experimental vaccines will be evaluated. Each company’s protocol is available at the following links: Moderna; Pfizer; and AstraZeneca.
Roche’s rheumatoid arthritis treatment Actemra (tocilizumab) led to a 44% lower chance of progression to mechanical ventilation or death in patients with COVID-19-associated pneumonia, according to results from the Phase 3 EMPACTA trial (NCT04372186). The randomized trial enrolled 389 hospitalized patients with COVID-19-associated pneumonia, 85% of whom were from minority racial and ethnic groups. Approximately 12% of patients treated with Actemra needed mechanical ventilation or had died by day 28, compared with approximately 19% of those on placebo.
Rigel Pharmaceuticals, in collaboration with the National Institutes of Health, has begun a Phase 2 trial to evaluate fostamatinib’s safety and efficacy in treating hospitalized COVID-19 patients. The trial will compare fostamatinib with a placebo in 60 patients on supplemental oxygen or ventilation. Participants will be treated twice a day for 14 days. Made by Rigel, fostamatinib, marketed in the U.S. as Tavalisse and Europe as Tavlesse, is approved to treat low platelet levels in the blood, a condition known as thrombocytopenia.
► Sept. 16, 2020
After temporarily pausing all global trials testing vaccine candidate AZD1222 due to safety concerns, AstraZeneca announced that it has now resumed the trial in the U.K. The trials were halted while an illness in one of the U.K. participants was investigated; the trial in the U.K. was resumed following approval from the country’s Medicines Healthcare Products Regulatory Agency. The company says it is working with regulatory authorities in other countries to determine when other trials can resume.
Mexico will receive 32 million doses of Russia’s Sputnik V vaccine starting in November, according to the Russian Direct Investment Fund (RDIF). The fund supported the development of the vaccine, which the Russian government approved last month, before it started Phase 3 testing. The doses, to be distributed by Mexico City-based Landsteiner Scientific, are enough to supply a quarter of Mexico’s population. The RDIF has also signed a deal with Brazil’s National Health Secretariat to supply up to 50 million doses of the vaccine to that country, with delivery also expected in November.
All 10 patients injected with vaccine candidate CPI-006 produced high levels of antibodies against the SARS-CoV-2 virus in the first two groups taking part in a Phase 1 trial (NCT04464395), according to early results. The experimental vaccine, being developed by Corvus Pharmaceuticals, also led to clinical improvements in all patients. Patients in these groups received either a 0.3 mg dose or a 1 mg dose of the compound. No treatment-related safety issues were reported. The open-label trial is recruiting approximately 30 participants with mild to moderate symptoms in New York and Pennsylvania. The next two groups in the study will receive 3 and 5 mg doses.
Barcitinib, in combination with remdesivir, shortened recovery time by one day among hospitalized COVID-19 patients, compared with remdesivir only, according to results from a Phase 3 trial (NCT04401579). The randomized trial included more than 1,000 patients to assess the safety and effectiveness of a 4 mg dose of barcitinib, plus remdesivir. Based on this data, Eli Lilly plans to discuss the possibility of an emergency use authorization with the U.S. Food and Drug Administration. Barcitinib, marketed by Lilly under the brand name Olumiant, is a treatment approved in 70 countries to treat rheumatoid arthritis.
Appili Therapeutics submitted a new protocol to the FDA for a Phase 3 U.S. trial of its influenza medication favipiravir as an early outpatient treatment for COVID-19. The study aims to determine whether the medication, given as an oral tablet, can safely and effectively treat mild to moderate COVID-19. It will also assess whether favipiravir can shorten recovery time and stop infections from advancing to more serious illness. Appili plans to begin recruiting participants for the trial in the fall. It will enroll an estimated 826 COVID-19 patients with mild to moderate symptoms, who will be randomized to receive either favipiravir or a placebo.
Diffusion Pharmaceuticals dosed the first two participants in its open-label Phase 1b trial testing trans sodium crocetinate (TSC) in hospitalized COVID-19 patients. TSC is an oxygen-enhancing therapy designed to increase arterial blood oxygen levels. The trial involves 24 hospitalized COVID-19 patients and is taking place at the Romanian National Institute of Infectious Diseases. The company is planning a follow-up trial that will take place in the U.S. and Europe, pending approval from regulatory authorities.
REGN-COV2, an antibody combination developed by Regeneron and the University of Oxford, will be added to the Phase 3 RECOVERY trial. The effects of REGN-COV2 plus standard care will be compared with standard care alone among 4,000 hospitalized COVID-19 patients. REGN-COV2 is the first treatment specifically designed for COVID-19 patients to be evaluated in the study, which is one of the largest clinical trials in the world testing potential therapies for the virus.
► Sept. 9, 2020
Russia’s approved COVID-19 vaccine, called Sputnik V, appears to be safe and trigger immune reactions in adults, according to results recently published in The Lancet. The results are based on two open-label Phase 1/2 studies (NCT04436471 and NCT04437875) that included 76 healthy volunteers ages 18 to 60. The experimental vaccine was found safe, well-tolerated, and induced an immune response in 100% of the participants. Researchers noted that more study is needed to confirm the effectiveness of the vaccine. A Phase 3 trial in 40,000 volunteers is now underway.
AstraZeneca‘s global late-stage trials (NCT04516746) testing its COVID-19 vaccine candidate, AZD1222, in multiple countries, including the U.S. and U.K., have been paused due to an illness in one of the U.K. volunteers. It is not known yet if the illness, which, according to preliminary reports, may be transverse myelitis, is directly related to the vaccine candidate; the trials will be halted while researchers investigate the event and determine its cause. The company recently launched a large-scale Phase 3 trial in the U.S. recruiting approximately 30,000 participants. It had also announced the start of a Phase 1/2 trial of AZD1222 in Japan; it is unclear if this trial is affected.
A National Institutes of Health advisory panel released a statement questioning the value of convalescent plasma — plasma from recovered patients — as a treatment for COVID-19. The U.S. Food and Drug Administration had issued emergency use authorization for convalescent plasma to treat COVID-19, but the NIH’s COVID-19 Treatment Guidelines Panel reviewed the same data and concluded that “there are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.” They further recommended that convalescent plasma not be considered standard care for COVID-19 patients and advised more study in the way of well-designed randomized trials to adequately assess its use in these patients.
The Italian Medicines Agency approved a global Phase 2/3 trial (NCT04467840) testing RedHill Biopharma’s Yeliva (opaganib) versus a placebo with standard care for the treatment of severe COVID-19 patients requiring both hospitalization and supplemental oxygen. The study is recruiting an estimated 270 participants in Mexico and the Russian Federation. It has also been approved in the U.K. RedHill plans to file an emergency use authorization application for Yeliva, a treatment with anticancer, anti-inflammatory, and anti-viral activities, as early as the end of the year.
Separately, an independent safety monitoring committee recommended the continuation of a separate Phase 2 trial (NCT04414618) in the U.S., also evaluating Yeliva versus a placebo in 40 hospitalized patients with severe COVID-19 who require supplemental oxygen. This trial is also currently recruiting participants.
Sanofi and GlaxoSmithKline began a Phase 1/2 trial (NCT04537208) testing their COVID-19 vaccine candidate in the U.S. The trial will compare the potential vaccine’s safety, tolerability, and ability to induce an immune response compared with a placebo in 440 healthy adults across 11 sites. The companies anticipate reporting data from the trial by December, at which point they plan to begin a Phase 3 trial to further test the vaccine. Pending positive results, the collaborators plan to file for approval in the first half of 2021.
The CEOs of nine companies developing COVID-19 vaccines signed a letter stating they would not seek emergency approval for their vaccines until they are proven safe and effective in large-scale trials. Several of the companies currently have vaccine candidates in late-stage testing and could potentially seek such an approval before the end of the year. The letter follows multiple reports that the Trump administration is considering granting emergency approval prior to the upcoming U.S. elections and before a potential vaccine completes Phase 3 testing. The companies that signed the letter are: AstraZeneca, Moderna, BioNTech, Pfizer, GlaxoSmithKline, Johnson & Johnson, Merck (known as MSD outside the U.S. and Canada), Novavax, and Sanofi.
► Sept. 2, 2020
Sanofi and Regeneron are ending testing on Kevzara (sarilumab) as a possible COVID-19 treatment after the therapy failed to to meet its primary objectives, including shortening hospital stays and accelerating improvements in clinical outcomes, in a global Phase 3 trial. Some patients also experienced serious adverse events, including pneumonia. The randomized trial was testing 200 mg or 400 mg doses of Kevzara in 420 severely or critically ill patients hospitalized with COVID-19. The companies are not planning any further studies in Kevzara for any COVID-19 indications.
Moderna’s COVID-19 vaccine candidate triggered a strong immune response among adults over 55 years old in a Phase 1 trial (NCT04283461), the company has reported. The ongoing open-label trial, taking place in the U.S., is testing various doses of the experimental vaccine, called mRNA-1273, in healthy adults in different age groups. These results parallel those found in younger participants (ages 18-55) in July.
Partner Therapeutics has enrolled its first patient in a Phase 2 trial (NCT04411680) testing inhaled Leukine (sargramostim) in hospitalized COVID-19 patients with acute hypoxemia. The trial will assess whether the therapy can improve oxygenation and reduce the need for intubation among these patients. It seeks to enroll 60 patients, who will be randomly assigned to receive either standard care alone or Leukine in addition to standard care. The trial takes place in Utah and is actively recruiting; more information can be found here. The therapy is approved to treat acute radiation syndrome, among other indications.
VBI Vaccines has selected two COVID-19 vaccine candidates for further development. The company expects to begin a Phase 1/2 trial in humans by the end of the year. Preclinical studies showed that the candidates, VBI-2901 and VBI-2902, generated neutralizing antibodies at rates higher than those seen in convalescent plasma — plasma from recovered COVID-19 patients — after a single dose. The Canadian government granted VBI a $42 million contract earlier this month to support its COVID-19 vaccine development program through Phase 2 testing.
Johnson & Johnson is set to begin a Phase 2 trial of its COVID-19 vaccine candidate, Ad26.COV2.S, in Spain, Germany, and the Netherlands this week. The trial aims to enroll 550 healthy adults ages 18 to 55 and over the age of 65, including 190 people in Spain, which shoulders Western Europe’s highest tally of cases. The study will evaluate different doses and administration methods of the vaccine candidate. The company also expects to begin a Phase 3 trial of Ad26.COV2.S in 60,000 participants in early September.
The first patient has been dosed in a Phase 2/3 trial of VIR-7831, an investigational COVID-19 antibody being jointly developed by GlaxoSmithKline and Vir Biotechnology for early treatment of patients at high risk of hospitalization. The study seeks to determine whether a single dose of the antibody can prevent hospitalization in COVID-19 patients. The trial aims to enroll 1,300 participants with early symptomatic infection, and who are at high risk of severe progression. Initial results of the trial could be available by the end of this year, and the companies expect complete results in the first quarter of 2021.
► Aug. 26, 2020
The Brazilian National Health Surveillance Agency has approved a Phase 1 trial of Janssen Pharmaceuticals’ COVID-19 vaccine candidate, Ad26.COV2.S. The trial is enrolling up to 6,000 participants. The potential vaccine is the fourth to begin a trial in Brazil, which, at 3.4 million cases and more than 108,000 deaths, is experiencing the second-highest number of COVID-19 cases globally after the U.S.
Hospitalized COVID-19 patients with pneumonia may improve quicker when treated with tradipitant, an investigational anti-inflammatory treatment being developed by Vanda Pharmaceuticals, according to interim results from an ongoing Phase 3 trial (NCT04326426). After 14 days of treatment, the percentage of patients who improved overall was similar, at 57% for tradipitant versus 50% for placebo, but those on tradipitant recovered earlier by day seven than those on placebo. The results come from 60 participants from a target study size of 300.
A new European research consortium is bringing together dozens of research teams from around the world to accelerate the discovery and development of COVID-19 treatments. Called the Corona Accelerated R&D in Europe, or CARE, project and founded by Johnson & Johnson, the consortium consists of 37 partners from Europe, China, the U.K., and the U.S. The group is funded in part by a €77.7 million ($93 million) grant from Europe’s Innovative Medicines Initiative.
The U.S. Food and Drug Administration has granted emergency use authorization for convalescent plasma for the treatment of hospitalized COVID-19 patients. Convalescent plasma is antibody-rich plasma taken from recovered patients. Originally scheduled to be cleared for use earlier this month, The New York Times reported last week that top government health officials had asked for a delay in authorization, citing a lack of rigorous data supporting its use. According to the FDA, sufficient criteria to authorize the use of convalescent plasma have now been met, but randomized controlled trials should continue as planned.
A five-day course of remdesivir showed clinical benefits for patients with moderate pneumonia associated with COVID-19, according to new data from a Phase 3 trial, published in the Journal of the American Medical Association. The trial (NCT04292730) randomized nearly 600 patients at hospitals across U.S., Europe, and Asia to treatment with remdesivir or standard care for either five or 10 days. The results showed that those on the five-day course of remdesevir were more likely to improve than those on standard care, but the significance of this finding is not yet clear, the researchers said. There was no statistical difference in clinical status between those treated with remdesivir and those on standard care in the 10-day treatment arm.
Russia is gearing up to start Phase 3 trials to test its Sputnik V COVID-19 vaccine late next week, according to state news agency Tass. The trial is expected to last up to 10 months and involve 40,000 volunteers. The vaccine was developed at Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology and approved for use in Russia on Aug. 11, despite not having undergone a late-stage trial.
AstraZeneca dosed the first patient in a Phase 1 trial testing the safety, tolerability, and pharmacokinetics (how a drug moves through the body) of AZD7442, a two-antibody combination designed to prevent or treat infections from the SARS-CoV-2 virus. The trial (NCT04507256) is taking place in the U.K. and expects to enroll up to 48 healthy volunteers, ages 18 to 55, who will be randomly assigned to receive either AZD7442 or a placebo. Preliminary results are expected later this year.
► Aug. 19, 2020
Heartburn medication famotidine was linked to improved outcomes in hospitalized COVID-19 patients, according to a paper published on a preprint server. The observational study found that 10% of the 84 patients given famotidine within 24 hours of hospitalization died or were put on ventilation, compared with 22% of the 1,536 who did not receive famotidine. According to the researchers, because the study was observational and conducted at a single center, the results should be interpreted with caution and more study is needed, including randomized controlled trials.
Vir Biotechnology announced plans to begin a Phase 2/3 trial of VIR-7831, its investigational therapy for treating COVID-19 patients. VIR-7831 is a neutralizing monoclonal antibody that showed positive preclinical results. The company also plans to evaluate the medicine’s use in preventing COVID-19 infections. The trial is set to begin later this month, with the company anticipating preliminary data before the end of the year.
China-based CanSino is launching a Phase 3 trial of its vaccine candidate in Pakistan. Pakistan’s National Institute of Health and pharmaceutical company AJM will run the trial, which is slated to begin next month and aims to include approximately 10,000 participants. The potential vaccine, called Ad5-nCoV, has already been approved for use by China’s military, and the company is working on setting up late-stage trials in Saudi Arabia, Russia, Brazil, Mexico, and Chile.
Novavax has begun a Phase 2b trial of its vaccine candidate NVX-CoV2373 in South Africa, which is experiencing a winter surge of COVID-19 cases. The trial will assess the efficacy of the experimental vaccine in approximately 2,665 healthy people. It also will evaluate the vaccine’s safety and ability to trigger an immune response in approximately 240 HIV-positive adults. The trial is being conducted in collaboration with Wits University.
The U.K. government secured early access to 90 million COVID-19 vaccine doses from Novavax and Johnson & Johnson. The government agreed to purchase 60 million doses of Novavax’s NVX-CoV2373 and 30 million doses of Johnson & Johnson’s Ad26.COV2.S. The deal includes an option to purchase an additional 22 million doses from Johnson & Johnson. The government will also provide support for Novavax’s Phase 3 trial testing NVX-CoV2373 in the U.K. and Johnson & Johnson’s long-term global Phase 3 trial testing Ad26.COV2.S.
The European Union reached an agreement with AstraZeneca to purchase 300 million doses of the company’s potential COVID-19 vaccine. This is the EU’s first agreement to supply member countries with an experimental coronavirus vaccine. The EU also said that it was in “exploratory talks” with Johnson & Johnson for access to that company’s vaccine candidate Ad26.COV2.S.
AstraZeneca and mAbxience will collaborate to produce AstraZeneca’s COVID-19 vaccine for most of Latin America. mAbxience’s Argentine laboratory will produce the shot’s active ingredient, with packaging to take place in Mexico. The deal provides funds for an initial production of 150 million doses, which can be extended to up to 250 million doses. Should the vaccine be approved, deliveries may begin in the first half of 2021. AstraZeneca has a separate supply agreement with Brazil.
► Aug. 12, 2020
Sinovac, in collaboration with vaccine manufacturer BioFarma, is launching a Phase 3 trial (NCT04508075) for its vaccine candidate, CoronaVac, in Indonesia. The trial aims to enroll 1,620 healthy adults who will be randomly assigned to receive either CoronaVac or a placebo. The main goal is to assess the vaccine’s safety, efficacy, and ability to generate an immune response. An inactivated form of the coronavirus, the experimental vaccine was able to induce an immune response in more than 90% of participants in early-stage trials, according to results reported in June. CoronaVac is also in Phase 3 testing in Brazil.
The National Institute of Allergy and Infectious Diseases launched a Phase 3 trial (NCT04492475) of Gilead Sciences’ experimental treatment remdesivir together with EMD Serono’s anti-inflammatory medication Rebif (interferon-beta-1a) for the treatment of people hospitalized with confirmed COVID-19 and evidence of lung involvement. The trial will test the safety and efficacy of the combined treatment, compared with remdesivir plus placebo. Called ACTT3, the trial aims to enroll roughly 1,000 participants across the U.S. Results published in May showed that patients on remdesevir recovered faster than patients on a placebo.
Russia’s Ministry of Health has approved a vaccine called Sputnik V for the prevention of COVID-19. Vaccine production is scheduled to begin at two sites in Russia, the country’s health minister said in a meeting with government members. However, experts warn that the vaccine was tested in only two small early-stage trials, the results of which were not made available. They fear that without large trials, the vaccine may be ineffective or even dangerous, as it has yet to be tested in a Phase 3 trial.
Humanigen will begin a Phase 3 trial of lenzilumab, an engineered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat cytokine storm, for the treatment of COVID-19 patients in Brazil, following approval to proceed from the Brazilian Health Regulatory Agency. The randomized trial, to take place among adults hospitalized with severe COVID-19 at high risk of disease progression, is an expansion of the company’s Phase 3 study (NCT04351152) in the U.S.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, secured a more than $1 billion deal with the U.S. government to manufacture and deliver 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, in the U.S., pending regulatory approval or emergency use authorization. The deal includes an option for the government to purchase an additional 200 million doses. Phase 1/2 trials assessing the vaccine candidate are underway in the U.S. and Belgium.
The FDA approved a Phase 2/3 trial (NCT04360096) of inhaled aviptadil developed by Relief Therapeutics. The trial, sponsored by NeuroRx, will evaluate the medication’s ability to prevent progression to respiratory failure among patients with moderate to severe COVID-19. The first part of the study will recruit hospitalized patients with severe disease and is expected to begin on or before Sept. 1. Aviptadil was previously awarded the FDA’s orphan drug designation for the treatment of acute respiratory distress syndrome, pulmonary arterial hypertension, acute lung injury, and sarcoidosis.
The U.S. government paused its plan to give $765 million to Eastman Kodak to manufacture COVID-19 vaccine components after allegations of insider trading. The U.S. International Development Finance Corporation (IDFC) tweeted that it would “not proceed any further unless these allegations are cleared.” Four Kodak executives had received stock options potentially worth millions of dollars the day before signing a letter of interest with the IDFC, regarding the government loan.
► Aug. 5, 2020
Roche’s anti-inflammatory medication Actemra (tocilizumab) failed to show benefits in patients hospitalized with severe COVID-19-associated pneumonia, according to results from a Phase 3 trial (NCT04320615). At week four, there was no difference between the therapy and a placebo in terms of patients’ clinical status or mortality. The company says it is continuing to test Actemra in different COVID-19 settings with other antiviral medications. Actemra is approved for a variety of indications, including rheumatoid arthritis and juvenile idiopathic arthritis.
The U.K. government reached an agreement with Sanofi and GlaxoSmithKline to provide up to 60 million doses of their COVID-19 vaccine upon regulatory approval. The two companies have been collaborating since April to develop a vaccine. Sanofi anticipates the start of a Phase 1/2 trial of the potential vaccine in September and a Phase 3 study by the end of the year. Both companies continue to seek agreements with other countries to provide global access.
Similarly, the U.S. government awarded Sanofi and GSK up to $2.1 billion as part of Operation Warp Speed to support the development of the vaccine candidate, as well as manufacturing, scale-up, and delivery of an initial 100 million doses of the vaccine, pending approval.
Following positive preclinical results, Johnson & Johnson has begun a Phase 1/2a trial (NCT04436276) of its COVID-19 vaccine candidate, Ad26.COV2.S. The trial is evaluating the safety and efficacy of two different dose levels of the experimental vaccine administered as either a single shot or two shots given eight weeks apart. The study aims to enroll approximately 1,000 healthy adults in the U.S. and Belgium. The company is also planning a Phase 1 trial in Japan and a Phase 2a trial in the Netherlands, Spain, and Germany. Pending positive interim results from these trials, two Phase 3 studies of the investigational vaccine are planned to start in September, one testing a single dose and the other testing the two-dose regimen compared with a placebo.
Pfizer and BioNTech reached an agreement with Japan to supply 120 million doses of their vaccine candidate, BNT162, starting in 2021 and pending success in clinical trials and regulatory approval. The two companies began a global Phase 2/3 trial (NCT04368728) of their lead vaccine candidate, BNT162b2, last week, following positive data in early-stage trials. According to the companies, they are on track to potentially request regulatory approval as early as October if the trials prove successful.
Eli Lilly announced the start of a Phase 3 trial called BLAZE-2 to assess the ability of its monoclonal antibody LY-CoV555 to prevent COVID-19 in residents and staff at long-term care facilities. The antibody, developed in collaboration with AbCellera, will be administered to residents and staff at facilities with recently diagnosed COVID-19 cases and who are at a high risk of exposure. The trial aims to enroll up to 2,400 volunteers.
Partner Therapeutics has signed a $35 million deal with the Department of Defense to fund two trials that will assess the benefits of inhaled Leukine (sargramostim) in patients with acute hypoxemia related to COVID-19. The trials will look at the therapy’s ability to improve oxygenation and percent of patients intubated, among other outcomes. The FDA accepted an investigational new drug application for Leukine in May, and the first of the two DOD-funded trials (NCT04411680) is expected to start this month. Leukine is also being studied in trials in Belgium and Japan for other COVID-19-associated conditions. The therapy was previously approved and is used to treat acute radiation syndrome, among other indications.
► July 29, 2020
Moderna has begun a much-anticipated Phase 3 trial, called COVE (NCT04470427), testing its COVID-19 vaccine candidate, mRNA-1273. The randomized trial, being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority, seeks to determine whether the experimental vaccine can prevent symptomatic COVID-19 after two doses. Up to 30,000 participants will be randomly assigned to receive either two 100-microgram injections of mRNA-1273 or a placebo 29 days apart. The study will take place at close to 100 sites across the U.S.
Pfizer and BioNTech have launched a global Phase 2/3 trial (NCT04368728) to test their lead COVID-19 vaccine candidate, BNT162b2, for the prevention of COVID-19. The trial will recruit up to 30,000 participants at approximately 120 sites worldwide, with the exception of China. Participants will be randomized to receive either the vaccine or a placebo in a two-dose regimen of 30 micrograms each. Early-stage results from Germany and the U.S. have shown the vaccine is both safe and generates an immune response.
In related news, the U.S. government, via the Department of Defense and HHS, signed a $1.95 billion agreement with Pfizer and BioNTech for the first 100 million doses of their COVID-19 vaccine after its potential FDA authorization or approval. The agreement, which is part of the government’s Operation Warp Speed program, allows the U.S. to acquire up to an additional 500 million doses of the vaccine.
Humanigen‘s lenzilumab was selected for the National Institutes of Health’s Big Effect Trial, where it will be tested in hospitalized COVID-19 patients. The investigational therapy will be evaluated in combination with remdesivir compared with a placebo or remdesivir alone. The Big Effect Trial is designed to advance promising therapeutic candidates that are readily available and for which there is already human data. Lenzilumab is currently in a Phase 3 trial (NCT04351152) to assess its ability to treat immune-mediated cytokine release syndrome and prevent respiratory failure and/or death in patients with COVID-19 pneumonia.
Dynavax and Medigen Vaccine Biologics have partnered to develop an adjuvanted COVID-19 vaccine — one that is developed with components that improve the immune response. The companies will evaluate the performance of Medigen’s SARS-CoV-2 recombinant spike protein with Dynavax’s adjuvant CpG1018, which is normally contained in the company’s hepatitis B vaccine. The vaccine-adjuvant pair demonstrated strong immune responses in preclinical animal studies.
The U.S. Department of Justice says it does not plan to take action against pharmaceutical companies for sharing information that could allow them to fast-track the manufacturing of antibodies for treating COVID-19. According to the department’s statement, collaborative efforts among companies to expedite the development of critical treatments are “unlikely to lessen competition.” The companies, which include AstraZeneca, Genentech, and Eli Lilly, have agreed not to share information on pricing.
The U.S. government signed a letter of interest to provide a $765 million loan to Eastman Kodak Company as part of an effort to ensure adequate resources for vaccine manufacturing within the U.S. Best known for its camera components, Kodak is planning to launch Kodak Pharmaceuticals, a new arm of the company dedicated to making essential pharmaceutical components for which the FDA has determined there is a national shortage. Similarly, Fujifilm also received a $285 million government contract to produce vaccine components at its College Station, Texas, site.
► July 22, 2020
China-based Sinopharm has begun a Phase 3 trial for its COVID-19 vaccine candidate in the United Arab Emirates. The trial, reportedly the first in the world to enter Phase 3, is expected to last for three to six months and will evaluate two separate formulations of the vaccine candidate in 15,000 participants ages 18–60. The potential vaccine showed a 100% immune response in Phase 1 and 2 studies, according to the company.
Pfizer and BioNTech reported positive data for their lead vaccine candidate, BNT162b1, in an ongoing open-label Phase 1/2 trial in Germany. The vaccine is being tested in 60 healthy people who received either two doses BNT162b1 at 1 microgram (mcg), 10 mcg, 30 mcg, or 50 mcg, or a single 60 mcg injection. Those who received two doses developed high levels of neutralizing antibodies after their second dose. The vaccine also produced a strong T-cell response, a measure of the body’s immune response against the virus. The preliminary results are undergoing peer review for publication in a scientific journal.
Researchers at the University of Oxford in the U.K. reported positive safety and immunogenicity data related to their COVID-19 vaccine candidate, ChAdOx1 nCoV-19. Their results, published in the journal The Lancet, showed that ChAdOx1 nCoV-19 successfully raised antibodies against the virus and boosted a T-cell response among 1,077 healthy volunteers enrolled in a randomized Phase 1/2 trial. These findings, the researchers wrote, “support large-scale evaluation of this candidate vaccine in an ongoing phase 3 programme.”
Medicago has begun a Phase 1 trial (NCT04450004) of its plant-based COVID-19 vaccine candidate. The randomized trial will evaluate three doses of the potential vaccine among 180 healthy volunteers ages 8–55. Participants will receive the vaccine either alone or in combination with adjuvants from GlaxoSmithKline and Dynavax. Medicago hopes to progress to a Phase 2/3 trial in October.
The U.S. Food and Drug Administration has added the corticosteroid dexamethasone to the list of treatments that are temporarily authorized for compounding during the COVID-19 pandemic. Reuters reported in mid-June that the demand for dexamethasone was on the rise after researchers in the U.K. found that it lowered the number of deaths among critically ill COVID-19 patients.
The European Medicines Agency has developed an infrastructure for real-world monitoring of COVID-19 vaccines and medications after they receive authorization. To date, the agency has signed three contracts for observational research to support the safe and effective use of treatments and vaccines. It is partnering with Utrecht University and University Medical Center Utrecht on CONSIGN, a study on how COVID-19 and treatments affect women during different stages of pregnancy. In addition, it has partnered with IQVIA to create a framework for conducting multicenter cohort studies on the use of medications in COVID-19 patients. The agency is also working with Utrecht University on the ACCESS project, which is focused on conducting preparatory research on data sources and methods for monitoring COVID-19 vaccines in clinical practice after they are authorized.
An experimental inhaled interferon beta medication called SNG001 was able to lower the risk of developing severe disease among 101 COVID-19 patients in a Phase 2 trial (NCT04385095), according to its maker, Synairgen. The investigational therapy reduced the risk of severe disease by 79% compared with a placebo. Patients receiving the medication were also twice as likely to recover over the course of treatment than those taking the placebo. SNG001 is also being investigated as a treatment for chronic obstructive pulmonary disease (COPD).
► July 15, 2020
Interim results from a Phase 1 clinical trial (NCT04283461) assessing Moderna’s COVID-19 vaccine candidate were published in The New England Journal of Medicine. The open-label trial tested three doses of mRNA-1273 in 45 healthy volunteers. The analysis showed that the experimental vaccine was safe, causing only mild side effects, and generated a rapid and strong immune response. Following these promising results, mRNA-1273 is expected to enter Phase 3 testing (NCT04470427) in 30,000 individuals later this month.
Gilead Sciences has reportedly begun a Phase 1 trial for an inhaled version of its antiviral remdesivir. The trial is enrolling 60 healthy participants, ages 18 to 45, in the U.S. According to Gilead, the inhaled formulation may offer a better delivery option for less severe COVID-19 patients in the outpatient setting. The next stage of the study will evaluate the medication in COVID-19 patients who do not require hospitalization.
In a separate Phase 3 trial testing intravenous remdesivir (NCT04257656), Gilead reported that the antiviral medication led to a 62% lower risk of mortality in severe COVID-19 patients. The trial, dubbed SIMPLE-severe, compared remdesivir with standard care treatments. Results showed that 74% of patients treated with remdesivir recovered by day 14, compared with 59% of those receiving standard care alone.
Following last week’s positive early data, Pfizer and BioNTech received fast-track designation from the U.S. Food and Drug Administration for BNT162b1 and BNT162b2, two mRNA-based COVID-19 vaccine candidates. The promising results came from Phase 1/2 trials taking place in the U.S. and Germany, as well as from data obtained in animal studies. The vaccines are being developed under the companies’ Project Lightspeed program, which is testing four experimental vaccines against SARS-CoV-2, the virus that causes COVID-19.
Biocon received emergency approval in India for its antibody therapy itolizumab for the treatment of the potentially deadly cytokine release syndrome in cases of moderate to severe acute respiratory distress syndrome related to COVID-19. According to the company, it is the first biologic therapy to be approved worldwide for treating moderate to severe COVID-19 complications. The decision stems from the successful conclusion of a small, randomized, controlled trial carried out in several hospitals in Mumbai and New Delhi. The therapy is marketed under the brand name Alzumab to treat plaque psoriasis.
The Coalition for Epidemic Preparedness Innovations granted Clover Biopharmaceuticals $66 million to support the company’s early testing, including preclinical studies and Phase 1 trials, of its COVID-19 vaccine candidate, S-Trimer. The funds will also aid in the preparation of sites for a future global efficacy trial. The coalition may provide more funding, should this early stage of development prove successful.
Two U.K. universities have jointly launched a platform designed to accelerate the development of COVID-19 treatments. Called AGILE, the platform is aimed at evaluating potential therapies and fast-tracking promising ones into large-scale trials. AGILE was created by the Liverpool School of Tropical Medicine and the Southampton Clinical Trials Unit. Several other research and education institutions have also signed on to partner in the project. Ridgeback Biotherapeutics’ investigational antiviral EIDD-2801 will be the first treatment evaluated.
► July 8, 2020
Pfizer and BioNTech announced positive early data from their joint Phase 1/2 clinical trial testing BNT162b1, one of four COVID-19 vaccine candidates in their BNT162 mRNA-based vaccine program. Out of three dosages, all 24 participants who received the low (10 mcg) or medium (30 mcg) dose of the vaccine produced roughly two to three times more neutralizing antibodies than those seen in recovered COVID-19 patients, Adverse reactions were generally mild to moderate, and no serious adverse events were reported. The companies expect to select a lead candidate from the four experimental vaccines to advance into a Phase 2b/3 trial, which may launch later this month.
Japanese pharmaceutical company Fujifilm has announced a deal with India’s Dr. Reddy’s Laboratories and Dubai-based Global Response Aid for the development, manufacture, and sale of its anti-flu medication Avigan (favipiravir) as a possible COVID-19 treatment. Under the terms of the agreement, Dr. Reddy’s and Global Response Aid will have exclusive rights to the medication outside Japan, excluding Russia and China. Fujifilm will provide the two companies with data it has collected from its studies, which they will use to conduct clinical trials in countries where the infection is spreading. Trials in Japan and the U.S. are currently evaluating Avigan’s potential as a COVID-19 treatment, while India and Russia have already approved it for that use. Avigan has been approved in Japan as an influenza treatment since 2014.
The U.S. Food and Drug Administration issued emergency use authorization for Centogene’s new test kit for the detection of SARS-CoV-2, the virus that causes COVID-19. The test uses the well-established polymerase chain reaction technique to detect the virus in upper respiratory tract samples taken by oropharyngeal swab. The samples are collected from individuals who have been exposed to or are suspected to have the virus, and analyzed by qualified lab personnel in a Centogene laboratory.
EUSA Pharma has received FDA approval to launch a Phase 3 trial to evaluate the safety and efficacy of Sylvant (siltuximab) in hospitalized COVID-19 patients with acute respiratory distress syndrome. Sylvant is an antibody that blocks interleukin-6, a cell signaling molecule that can trigger inflammation. The trial expects to enroll approximately 400 patients who will be randomly assigned to receive either Sylvant or a placebo in addition to standard care. The primary measures will be improvements in lung function, length of hospital stays, and all-cause mortality. Sylvant is approved for the treatment of Castleman disease, a rare condition of the lymph nodes and related tissues.
The FDA granted Biophytis an investigational new drug clearance for a Phase 2/3 trial testing Sarconeos (BIO101), an experimental oral medicine for the treatment of acute respiratory failure associated with COVID-19. The first part of the trial will assess the medicine’s safety and efficacy in 50 hospitalized COVID-19 patients experiencing acute respiratory deficiency. The second part will evaluate the efficacy of Sarconeos on respiratory function in an additional 300 patients. Biophytis has been developing Sarconeos for the treatment of sarcopenia (muscle loss due to aging), and Duchenne muscular dystrophy.
Regeneron announced the start of a Phase 3 trial to study whether an antibody cocktail dubbed REGEN-COV2 can prevent COVID-19 infections among those who have been exposed to the virus. The trial is being conducted in collaboration with the National Institute of Allergy and infectious Diseases. Following a positive Phase 1 safety review from an independent monitoring committee, the company is also advancing the therapy into two Phase 2/3 trials in hospitalized and ambulatory COVID-19 patients. Under the Operation Warp Speed program, the U.S. government recently signed a $450 million deal with Regeneron for the manufacturing of REGEN-COV2 upon successful completion of clinical trials.
The U.S. government signed a similar deal with Novavax, providing the Maryland-based pharmaceutical company $1.6 billion to manufacture up to 100 million doses of its experimental vaccine, NVX‑CoV2373. The doses owned by the government would become available for use in clinical trials or for distribution in the event of FDA emergency use authorization or approval of the vaccine. Novavax is currently testing NVX‑CoV2373 in 130 healthy volunteers in Australia in a Phase 1 trial (NCT04368988). The company expects early safety and immune response results this month.
The World Health Organization is halting the testing of hydroxychloroquine and Kaletra (lopinavir/ritonavir) in hospitalized COVID-19 patients in its multinational Solidarity trial after determining that these medications had little to no effect on mortality rates. Furthermore, the organization identified several adverse events associated with these compounds, which it will review. This decision does not extend to the possible study of these treatments in non-hospitalized patients or as a preventive measure before or after exposure to SARS-CoV-2.
► July 1, 2020
Gilead has set its price for the experimental antiviral remdesivir at $390 per vial. A five-day treatment course of six vials of the therapy, which is based on current treatment patterns, will equate to $2,340 per patient, Gilead CEO Daniel O’Day said in an open letter. In the U.S., however, the price of the treatment for private insurance companies will be $520 per vial, because of the unique characteristics of the U.S. system and the discounts that government healthcare programs expect. According to O’Day, this price will remove the need for country-by-country price negotiations. Gilead has entered into agreements with generic drugmakers to deliver treatment at a lower cost in the developing world. Remdesivir has shown promise in clinical trials against COVID-19.
FibroGen has begun a Phase 2 trial of pamrevlumab for the treatment of hospitalized COVID-19 patients. Pamrevlumab is an investigational monoclonal antibody that is also being tested for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer, and Duchenne muscular dystrophy. The randomized trial (NCT04432298), which is actively recruiting participants in the U.S., will assess pamrevlumab’s safety and efficacy in up to 130 patients with acute COVID-19, compared with a placebo. More information on enrollment can be found here.
The U.S. Food and Drug Administration approved the launch of Fulcrum Therapeutics’ Phase 3 trial of its investigational anti-inflammatory medication losmapimod for the treatment of hospitalized COVID-19 patients. The international, randomized trial, called LOSVID, will enroll an estimated 400 COVID-19 patients at risk of progressing to critical illness based on older age and elevated systemic inflammation. Participants will be randomized to either 15 mg twice per day of losmapimod or a placebo, in addition to standard care, for 14 days. The trial’s primary measure is the proportion of patients who progress to death or respiratory failure by day 28. Top-line data from the trial is expected in early 2021.
Catalent and Moderna have signed an agreement to fill and package 100 million doses of Moderna’s mRNA vaccine candidate — known as mRNA-1273 — with potential to produce hundreds of millions more. The companies hope to be able to begin distributing doses in the U.S. later this year. Catalent has inked similar agreements with Johnson & Johnson and AstraZeneca.
Vaxart’s COVID-19 vaccine candidate was selected to participate in a primate study funded by the U.S. government’s Operation Warp Speed, the company announced. Vaxart is developing this vaccine, and others in its pipeline, as oral tablets, rather than as an injectable liquid solution. “Vaxart believes that a room temperature stable tablet vaccine is easier to distribute, store and administer than injectable vaccines and may provide significantly faster response to a pandemic than injectable vaccines,” the company stated in a press release.
The U.S. Army Medical Research and Development Command awarded $4.7 million to Altimmune to fund a Phase 1/2 trial (NCT04442230) of T-COVID, an investigational COVID-19 outpatient treatment. T-COVID is an intranasal (administered via the nose) immune modulator, designed to prevent patients from progressing to a severe disease condition. Altimmune expects to begin recruiting participants for the trial in the coming weeks and to produce trial data by the end of the year.
The World Health Organization unveiled plans to secure 2 billion doses of a future COVID-19 vaccine by the end of 2021. The plan calls for countries to pool their resources to invest in a broad selection of experimental vaccines, thereby spreading the risk of betting on any particular candidate. The WHO estimates it will need $31.3 billion in funding over the next 12 months to execute its plan. To date, $3.4 billion has been secured from contributing countries.
Imperial College London dosed the first participant in a Phase 1 trial of its COVID-19 vaccine candidate. Researchers initially plan to recruit 15 healthy volunteers, in whom they will test the safety of increasing doses of the potential vaccine. After this, the goal is to scale up the trial to 300 participants, with larger trials being planned for later in the year. The trial is actively recruiting; more information can be found here.
Inovio recently announced positive results for its COVID-19 vaccine candidate, INO-4800. According to the company, 94% of the 36 healthy volunteers treated with the potential vaccine in a Phase 1 trial demonstrated an immunological response, but it provided few other supporting details. INO-4800 has also been selected for preclinical primate studies under the Operation Warp Speed program. The company is anticipating the launch of a Phase 2/3 efficacy trial sometime this summer.
► June 24, 2020
The U.S. Department of Health and Human Services recently released a fact sheet explaining the Operation Warp Speed program announced in mid-May. Pharmaceutical companies selected for the program, which is a public-private partnership aimed at stimulating COVID-19 vaccine, therapeutic, and diagnostic development, will gain priority access to manufacturing capacity and needed supplies. The goal of Operation Warp Speed is to deliver 300 million doses of a safe and effective vaccine by early next year. Fourteen vaccine candidates have already been identified, of which seven of the most promising will be chosen to advance to early-stage trials. Those candidates that are successful in early studies will then go on to testing in large-scale trials.
At the same time, the European Union has launched its own strategy to coordinate vaccine development for COVID-19, with the goal of having safe and effective vaccines available within 12 to 18 months. The European Commission will devote a significant portion of a roughly $3 billion emergency fund to advance purchases of potential COVID-19 vaccines from companies, with additional support made available through European Investment Bank loans. The commission has further proposed a global effort wherein high-income countries would support low- and middle-income countries in reserving vaccines, so that countries of all income levels have access to life-saving measures, when they become available.
The U.K. Medicines and Healthcare Products Regulatory Authority suspended recruitment for clinical trials of hydroxychloroquine as a potential treatment for COVID-19. The decision follows data from two trials, including the large-scale RECOVERY trial (NCT04381936), that found that the medication provides no meaningful benefit to hospitalized COVID-19 patients. The agency advises those taking hydroxychloroquine and chloroquine for other conditions to continue to do so, as advised by their physician.
Similarly, the World Health Organization has suspended the hydroxychloroquine arm of its global Solidarity trial, which is seeking effective treatments for COVID-19 patients. The WHO’s decision was based on results found in the Solidarity trial, as well as those of the RECOVERY trial and other reviewed evidence. According to the organization, its decision does not apply to the use of hydroxychloroquine as a preventive treatment among those who have been exposed to the virus.
Following positive results in another arm of the RECOVERY trial, the U.K. has authorized the National Health Service to treat COVID-19 with dexamethasone. Trial findings announced last week showed that the medicine reduced the risk of death among patients requiring both ventilation and oxygen-only therapies. The government has already taken steps to secure supplies of the medicine and currently has enough to treat more than 200,000 people.
Gilead Sciences will soon begin enrollment for an open-label Phase 2/3 trial (NCT04431453) testing the antiviral medication remdesivir among hospitalized children with COVID-19. The trial will assess remdesivir’s safety, tolerability, pharmacokinetics (movement in the body), and efficacy among approximately 50 patients, from newborns to adolescents, with mild to severe COVID-19. This trial will take place at more than 30 sites across the U.S. and Europe. Gilead has been providing remdesivir for children with severe COVID-19 under compassionate use since February.
Clover Biopharmaceuticals has begun a randomized Phase 1 trial (NCT04405908) of its COVID-19 vaccine candidate, SCB-2019, in Australia. The trial, which is enrolling an estimated 150 patients, will test SCB-2019 alongside adjuvant (assisting) medications from GlaxoSmithKline and Dynavax. The first patient was recently dosed, and the company expects preliminary results in August.
Sanofi intends to begin a Phase 1/2 trial of its COVID-19 vaccine candidate in September. If all goes well, the company anticipates full approval in early 2021. This timeline accelerates that which the company had earlier proposed, when it agreed to develop the vaccine with GlaxoSmithKline. Sanofi is also planning to start a Phase 1 trial by the end of the year testing an mRNA vaccine candidate developed in conjunction with Translate Bio. Pending positive results, it is aiming for approval in the latter half of 2021.
Glenmark Pharmaceuticals received approval for emergency use in India of its influenza antiviral favipiravir for treating mild to moderate COVID-19. This marks the first medication authorized for treating COVID-19 in the country. The company intends to market the therapy under the brand name FabiFlu. Glenmark is simultaneously conducting a Phase 3 trial of favipiravir as a COVID-19 monotherapy at nine sites across India.
► June 17, 2020
Dexamethasone has been shown to reduce the risk of death among COVID-19 patients needing supplemental oxygen, according to results from the Phase 2/3 RECOVERY trial (NCT04381936), a U.K. study that is testing a variety of potential therapies to treat the virus. Dexamethasone is a generic steroid often prescribed to treat inflammatory conditions. During the trial, the treatment lowered the risk of death by one-third among patients needing ventilation and by one-fifth in patients receiving oxygen therapy only. It showed no benefit in patients not requiring respiratory support. The researchers are now working to validate and publish the trial results.
The U.S. Food and Drug Administration has now revoked the emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19. Based on available evidence, the agency determined that suggested dosing regimens for the two treatments are unlikely to produce an antiviral effect, that observations of decreased viral shedding attributed to their use have not been consistently replicated, and that recent clinical trial data show no evidence of their benefit in treating COVID-19. According to the FDA letter, known and potential benefits of these treatments do not outweigh their known and potential risks.
Moderna, in collaboration with the U.S. National Institutes of Health, is planning to launch a 30,000-person, placebo-controlled Phase 3 trial of its candidate COVID-19 vaccine in July. The trial’s primary goal is to determine whether the vaccine, known as mRNA-1273, can prevent symptomatic COVID-19. Secondary measures will test the vaccine’s ability to prevent infection or hospitalization. The first group of healthy volunteers have been fully enrolled in the current Phase 2 trial (NCT04405076) testing the vaccine, which was granted fast track designation by the FDA in May.
Researchers at the Universities of Birmingham and Oxford in the U.K. are screening Izana Bioscience‘s namilumab and Celltrion Healthcare’s Remsima (infliximab) for the treatment of COVID-19 as part of the multi-arm, multi-stage CATALYST trial. Namilumab is a human monoclonal antibody already in late-stage clinical trials for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Infliximab is used to treat inflammatory conditions, including eight autoimmune diseases. The goal of the CATALYST trial is to identify existing therapies that have the potential to treat COVID-19 and can be funneled into large Phase 3 trials in hospitalized patients.
The European Medicines Agency has issued a statement advising patients to continue taking their blood pressure and heart medications as directed by their doctors during the pandemic. According to the agency, the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers have not shown any negative effects on patients with COVID-19 in numerous studies. The EMA says it will continue to monitor data and will provide ongoing advice on the safety of the medicines in collaboration with other regulators and international organizations.
Regeneron has begun the first Phase 1/2 trials (NCT04425629 and NCT04426695) testing REGN-COV2, an antibody cocktail, for the treatment of COVID-19 in hospitalized and non-hospitalized patients. The clinical program will also include trials that will assess REGN-COV2’s ability to prevent COVID-19 in two other groups: uninfected individuals at high-risk of exposure and uninfected individuals with close exposure to a COVID-19 patient. Phase 1/2 data will be used to guide the protocol for later Phase 3 studies.
AstraZeneca has licensed six potential COVID-19 antibodies from Vanderbilt University and plans to begin testing a combination of two of them within the next two months. The company has signed deals with the Biomedical Advanced Research and Development Authority and the Defense Advanced Research Projects Agency, both U.S. governmental agencies, to help advance this effort.
Eli Lilly began enrolling patients into a Phase 3 trial (NCT04421027) to test its rheumatoid arthritis treatment Olumiant (baricitinib) in hospitalized COVID-19 patients. This trial, which will complement other ongoing trials of baricitinib in COVID-19 patients, will evaluate the proportion of patients treated with 4 mg of Olumiant who die or require ventilation by day 28, compared with those given a placebo. Lilly expects to enroll about 400 patients in the U.S., Germany, Spain, and Mexico.
Preliminary results from a randomized Phase 1/2 trial (NCT04352608) showed that Sinovac’s COVID-19 vaccine candidate CoronaVac induced an immune response among patients. According to the Beijing-based company, more than 90% of participants generated neutralizing antibodies after receiving the vaccine and that no serious adverse events occurred. The company expects to advance the vaccine to a Phase 3 trial “in the near future.”
► June 10, 2020
Gilead Sciences has filed for approval in the European Union for remdesivir to treat COVID-19, according to the European Medicines Agency, which received a conditional marketing authorization application for the treatment. Because some of the data were already submitted under a rolling review, the agency expects to complete its review of the data under a shortened timeline. If the information submitted is deemed sufficient, the agency will work with the European Commission to potentially fast-track approval of the therapy.
Hydroxychloroquine provides no benefit to patients with COVID-19, according to preliminary results of the Phase 2/3 RECOVERY clinical trial (NCT04381936). The randomized study, which enrolled more than 11,000 patients across the U.K. and is testing a variety of therapies to treat the virus, found that the antimalarial showed no beneficial effect on the length of hospital stays nor on other disease outcomes. Based on these results, the investigators made the decision to stop enrolling patients in the hydroxychloroquine arm of the trial.
As the controversy over hydroxychloroquine continues, The Lancet journal recently retracted the article, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.” The study’s results showed there was no benefit to hydroxychloroquine or chloroquine treatment on hospital outcomes for COVID-19, but three of the paper’s authors made the decision to retract based on the fact that they had failed to complete an independent audit of the data underpinning their analysis. Because of this, they wrote in a statement for The Lancet, they “can no longer vouch for the veracity of the primary data sources.”
Brazil’s Ministry of Health approved clinical trials of AstraZeneca and Oxford University’s COVID-19 vaccine candidate, making it the first country outside the U.K. to do so. The vaccine candidate, known as both ChAdOx1 nCoV-19 and AZD1222, is one of the first to move into Phase 2 testing. Reuters has reported that this vaccine will simultaneously enter both Phase 2 and Phase 3 trials to speed its development. The first round of trials, conducted by Federal University of São Paulo and funded by Brazil’s Lemann Foundation, will test the vaccine in 2,000 volunteers who have not previously contracted COVID-19.
Inovio will begin testing its COVID-19 vaccine candidate, INO-4800, in a Phase 1/2 trial in South Korea later this month in collaboration with the International Vaccine Institute and Seoul National University Hospital. The trial will assess the vaccine’s safety, tolerability, and ability to produce an immune response in 40 adults, ages 19 to 50 years. Inovio plans to expand this trial to include an additional 120 people ages 19–64.
Eli Lilly has partnered with Shanghai-based biotech Junshi Biosciences to begin testing a second potential COVID-19 vaccine. Similar to Eli Lilly’s first candidate, known as LY-CoV555, JS016 is also an engineered antibody that showed promise in preclinical studies in neutralizing the SARS-CoV-2 virus, which causes COVID-19. The first healthy volunteer in a randomized Phase 1 trial was recently dosed at Huashan Hospital affiliated with Fudan University in China.
AbbVie has partnered with Harbour BioMed, Utrecht University, and Erasmus Medical Center to develop 47D11, a monoclonal antibody therapy for COVID-19. AbbVie will support its partners through preclinical activities while preparing for later-stage preclinical and clinical development. Under the terms of their agreement, AbbVie will also have the option to exclusively license the antibody for worldwide therapeutic development and commercialization.
Australian biotech CSL, along with the University of Queensland (UQ) and the Coalition for Epidemic Preparedness Innovations (CEPI), have joined forces to accelerate the development of a COVID-19 vaccine candidate first developed by UQ. CSL and CEPI will fund industrial-scale manufacturing of potentially 100 million vaccine doses by the end of 2021, should the product win approval.
Preliminary research shows that AstraZeneca’s blood cancer treatment Calquence (acalabrutinib) provides a benefit to hospitalized COVID-19 patients. Of 19 severe COVID-19 patients treated with Calquence, 11 who had needed supplemental oxygen no longer needed it, and four of eight patients on mechanical ventilation were successfully taken off. The company said the positive results support the launch of a global Phase 2 trial, which was announced in April.
FibroGen has enrolled the first patient in a Phase 2/3 trial in Italy to evaluate pulmonary fibrosis treatment pamrevlumab for severe COVID-19. The trial will assess the effect of pamrevlumab on blood oxygenation in 68 hospitalized patients who will receive either pamrevlumab or standard care. The company also is planning two Phase 2 trials in the U.S. to assess pamrevlumab versus standard care in patients with severe COVID-19.
► June 3, 2020
Gilead announced top-line results from its Phase 3 SIMPLE clinical trial (NCT04292899) testing the safety and antiviral activity of remdesivir. According to the results, patients who received remdesivir treatment for five days were 65% more likely to improve clinically at day 11 than those who received standard care.
A preliminary report from 1,059 patients participating in another Phase 3 trial called ACTT (NCT04280705), assessing the effects of remdesivir for the treatment of COVID-19, was published in The New England Journal of Medicine. Early results show that remdesivir was superior to a placebo in shortening the time to recovery in adults hospitalized with COVID-19 and lower respiratory tract infection.
With early data showing that redemsivir may speed up recovery time, certain U.K. patients hospitalized with COVID-19 who meet specific criteria will soon be able to access the investigational therapy. Patients will be selected based on expert clinical advice for greatest potential benefit. The plan is supported by the U.K. government, Gilead, the National Health Service, and the Medicines and Healthcare Products Regulatory Agency. Remdesivir has not yet been approved for any indication.
BerGenBio has dosed the first patient in its Phase 2 trial testing oral kinase inhibitor bemcentinib, along with standard care, in hospitalized COVID-19 patients. The treatment candidate is the first to be selected as part of the U.K.’s Accelerating COVID-19 Research & Development (ACCORD) platform, an initiative designed to rapidly test potential COVID-19 therapies in early trials before sending them into large-scale studies. The trial is recruiting an estimated 120 participants at eight sites across the U.K.
The first patients have been dosed in a Phase 1 trial (NCT04411628) led by Lilly and AbCellera to test an antibody treatment against COVID-19 called LY-CoV55. This marks the world’s first in-human study evaluating an antibody for treating the virus. The randomized, single ascending dose trial is evaluating the safety, tolerability, pharmacokinetics (movement in the body), and pharmacodynamics (effect on the body) of LY-CoV555 administered intravenously in patients hospitalized with COVID-19. The trial, which will enroll an estimated 40 participants, is currently open for recruitment at multiple sites in the U.S. It is expected to be completed on Aug. 23.
An investigational antiviral antibody being developed by Celltrion for COVID-19 has shown positive results in a preclinical study, the company announced. The study tested the efficacy of a high and low dose of the treatment candidate in an animal model. Results showed that the therapy led to a hundredfold reduction in viral load and reduced lung lesions to a normal level.
Advent has manufactured 13,000 doses of AZD1222, AstraZeneca’s experimental COVID-19 vaccine, for use in clinical testing. According to the Italy-based manufacturing company, it delivered 4,000 doses to the University of Oxford for its Phase 2/3 COV002 trial (NCT04400838), which is aimed at testing the potential vaccine in more than 10,000 healthy volunteers. It is not yet open for recruitment.
Massachusetts Eye and Ear and Massachusetts General Hospital have partnered with AveXis to develop a new potential genetic vaccine, called AAVCOVID, against COVID-19. The hospital will conduct safety and efficacy testing in preclinical studies, while AveXis will start manufacturing the vaccine. It will use a gene therapy approach, where a harmless adeno-associated virus will deliver a genetic code to human cells to make portions of SARS-CoV-2, the virus that causes COVID-19, to elicit an immune response.
PureTech will begin human clinical trials to test its experimental treatment LYT-100 (deupirfenidone) in people with respiratory complications following recovery from COVID-19 infections. LYT-100, an analog of the pulmonary fibrosis treatment Esbriet (pirfenidone) is currently being tested in a Phase 1 trial (NCT04243837) in healthy volunteers and patients with breast cancer-related lymphedema for safety, tolerability, and pharmacokinetics.
► May 27, 2020
Results from the first potential COVID-19 vaccine to be tested in a Phase 1 clinical trial (NCT04313127) were recently published in the journal The Lancet. They showed that the adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine was tolerable and able to trigger an immune response as early as 14 days after vaccination. The researchers concluded that the potential vaccine is worth further investigation but cautioned that they are still a long way off from having a COVID-19 vaccine available to all.
Novavax is enrolling the first participants in a Phase 1/2 trial testing its vaccine candidate, NVX‑CoV2373. The trial is being conducted in two parts, the first of which is taking place in Australia and is testing the safety and immune response in healthy volunteers, ages 18 to 59. The Phase 2 portion will be conducted in multiple countries and will include a broader age range to test the vaccine’s safety, immunity, and ability to reduce COVID-19 disease.
Glenmark Pharmaceuticals is launching a Phase 3 trial in India to test if early treatment with favipiravir and umifenovir improves the efficacy of the antiviral combination in hospitalized COVID-19 patients. The trial is expected to enroll approximately 158 participants with moderate COVID-19, who will be randomized to receive favipiravir either with or without umifenovir, plus standard care.
Covis Pharma has announced the start of a Phase 3 trial (NCT04377711) to assess the safety and efficacy of the asthma medication Alvesco (ciclesonide) in people with symptoms of COVID-19, ages 12 and older who are not hospitalized. Researchers think the treatment may suppress viral replication and alleviate symptoms of the disease. The multicenter, randomized trial is expected to recruit 400 participants across the U.S. and is estimated to be completed by the end of the year.
A new trial (NCT04303507) led by the University of Oxford and the Mahidol Oxford Tropical Medicine Research Unit in Thailand is recruiting participants to test the effect of chloroquine and hydroxychloroquine on COVID-19. The randomized trial will enroll an estimated 40,000 healthcare workers across Europe, Africa, Asia, and South America who have had close contact with patients with either proven or suspected COVID-19. There is currently no conclusive proof that either chloroquine or hydroxychloroquine can prevent or treat COVID-19.
Octapharma is launching a Phase 3 trial to test whether Octagam 10%, its intravenous immune globulin therapy, can slow or prevent respiratory deterioration in COVID-19 patients.The multicenter, randomized trial will enroll 54 patients with severe COVID-19 at approximately 10 sites in the U.S. Octagam 10% is an approved treatment for chronic immune thrombocytopenic purpura in adults.
IMV has selected a vaccine candidate against COVID-19 that it plans to advance into in-human studies. The vaccine, called DPX-COVID-19, is based on peptide epitopes that showed robust immune and antibody responses in preclinical studies. The company anticipates launching a Phase 1 trial to test the potential vaccine this summer.
AstraZeneca has finalized agreements for the first 400 million doses of its vaccine candidate being developed by the University of Oxford. It has already secured manufacturing capacity for 1 billion doses and plans to begin the first deliveries in September. The vaccine, called AZD1222, (previously ChAdOx1 nCoV-19) is being tested in a Phase 1/2 trial (NCT04324606) to determine the safety, efficacy, and immune response in more than 1,000 healthy volunteers.
► May 20, 2020
Moderna announced positive interim results from a Phase 1 clinical trial (NCT04283461) testing its potential COVID-19 vaccine mRNA-1273. The trial, led by the National Institutes of Health, is testing three different doses of mRNA-1273 in healthy volunteers ages 18–55 for safety, immune response, and adverse effects. The results so far show that the vaccine is generally safe and well tolerated. Moderna is planning a Phase 2 trial to further test the potential vaccine and determine the right dose to be used in pivotal studies expected to start in July. The Phase 1 trial is still recruiting healthy volunteers in Georgia, Maryland, and Washington.
NeuroRx is sponsoring a Phase 2b/3 trial (NCT04360096) that will test aviptadil in critically ill COVID-19 patients. The goal of the trial is to identify COVID-19 patients with non-acute lung injury and treat them with aviptadil in hopes of preventing progression from non-acute to acute lung injury and acute respiratory distress syndrome, or ARDS, both complications associated with COVID-19. The multicenter, randomized, placebo-controlled trial will recruit approximately 144 participants with COVID-19 and evidence of lung injury. Enrollment is not yet open.
Stanford Medicine is currently enrolling participants in a Phase 2 trial (NCT04331899) testing whether peginterferon lambda-1a can help patients to recover faster and limit viral shedding, which lowers the risk of transmission to others. The open-label, randomized trial is recruiting an estimated 120 participants in California, ages 18 to 64, with an initial diagnosis of COVID-19 and symptoms of respiratory infection without respiratory distress. Peginterferon lambda-1a is an antiviral that has already been tested against viruses that cause hepatitis.
The University of Oxford has launched a trial in the U.K. that will test the ability of existing treatments such as hydroxychloroquine and azithromycin to prevent, slow, or even halt the progression of COVID-19 and reduce the severity of its symptoms, avoiding hospital admissions in people older than 50.
The FDA completed its review of ViralClear’s investigational new drug application for merimepodib to treat adults with advanced COVID-19. This means the company can now start its proposed Phase 2 trial testing the potential treatment. The trial will be randomized, double blind, and placebo-controlled and is expected to be conducted at multiple sites across the U.S. It will test the safety and efficacy of merimepodib in adults infected with SARS-CoV-2 and admitted to the hospital requiring supplemental oxygen.
Interim results from a multicenter, randomized trial in Russia testing Avigan (favipiravir) showed that 60% of the 40 patients with COVID-19 who received the treatment tested negative for the virus after five days, according to the Russian Direct Investment Fund, which is financing the study. The trial is expected to include 330 participants with confirmed COVID-19 at sites across Russia. Avigan is an antiviral first developed in Japan for the treatment of influenza.
Results from an observational study in France show that hydroxychloroquine does not significantly lower admissions to intensive care or death in patients hospitalized with pneumonia due to COVID-19. In addition, a randomized trial in China found that patients with mild to moderate COVID-19 treated with the anti-malarial drug did not clear the virus quicker than those receiving standard care. More adverse events were also recorded in patients treated with hydroxychloroquine. Findings from both studies, published in The BMJ journal, add to growing evidence that hydroxychloroquine may not be effective against COVID-19.
► May 13, 2020
Moderna’s investigational mRNA vaccine for COVID-19, called mRNA-1273, was awarded the FDA’s fast-track designation, the first to receive this status, which is intended to speed up the review time for a potential medication. The company anticipates launching a Phase 3 trial testing the vaccine in early summer.
An observational study conducted by the University of Albany and the New York State Department of Health found no benefit to treating COVID-19 patients with hydroxychloroquine. This is at least the third such study to reach this conclusion, according to the FDA. After reviewing the medical records of 1,438 patients from 25 hospitals in the greater New York area, the researchers found that treatment with hydroxychloroquine, azithromycin, or both did not significantly lower the in-hospital death rate. The study was published in the Journal of the American Medical Association.
rolling out a second Phase 3 trial the safety and efficacy of compared with standard care in patients with COVID-19 who develop . Jakafi is a prescription medication for , , and . The trial will be conducted in the U.S. The companies had previously announced a Phase 3 trial called RUXCOVID, which is examining Jakafi’s effectiveness in treating COVID-19-associated cytokine storm. That trial is currently underway.and are
A new Phase 2 trial National Institute of Allergy and Infectious Diseases, follows on the heels of another study that found that remdesivir on its own shortened patients’ recovery time over a placebo.to investigate the effectiveness of with in treating COVID-19. It is expected to enroll up to 1,000 participants at 100 sites worldwide. Enrollment has already begun in the U.S. Remdesivir is an investigational broad-spectrum antiviral being developed by . It is not yet approved anywhere in the world for any indication. Olumiant is an anti-inflammatory by used to treat some patients with . The trial, being sponsored by the
A Phase 2 trial (combo therapy suppressed the virus at day seven. This was five days earlier than in patients who were treated with Kaletra only. The combo was also found to be safe, leading to minor gastrointestinal side effects such as diarrhea and vomiting.) conducted in China tested a combination of three antivirals, (lopinavir-ritonavir), an antiviral, , a treatment, and , a treatment used in . The trial, completed on March 31, that the
The FDA emergency use authorization for a new laboratory test kit to detect SARS-CoV-2. The kit, called can detect the genetic material of the virus in oral and nasal swabs as well as sputum.
► May 6, 2020
The U.S. Food and Drug Administration has granted Gilead Sciences’ remdesivir emergency use authorization for the treatment of COVID-19, the company recently announced. The agency’s decision was based on available data from two global Phase 3 clinical trials.
Top-line results from one of these Phase 3 trials, known as SIMPLE (NCT04292899), showed that a shorter, five-day course of treatment with remdesivir leads to similar improvements in clinical status as a 10-day course of treatment in patients hospitalized with severe COVID-19. The open-label trial is testing the effects of two dosing durations (five days and 10 days) of the experimental antiviral.
The European Medicines Agency also began a rolling review of remdesivir for COVID-19, with the goal of shortening the review time of the treatment from months to weeks.
The FDA granted emergency use authorization to a new antibody test for COVID-19. The test, developed by Roche, is called Elecsys. It is able to determine with 100% sensitivity and 99.8% specificity whether a person has been exposed to SARS-CoV-2 in the past and developed antibodies against the virus.
The first participants have been dosed in a Phase 1/2 trial in the U.S. that is testing four mRNA vaccine candidates being jointly developed by BioNTech and Pfizer against COVID-19. The first part of the trial is a dose escalation stage that is enrolling up to 360 healthy individuals. The BNT162 vaccine program also includes a similar trial in Germany, which completed dosing of its first group last week.
Massachusetts General Hospital is conducting a clinical study to assess the potential efficacy of inhaled nitric oxide to reverse hypoxemia (abnormally low oxygen levels in the blood) in patients with severe COVID-19. Mallinckrodt Pharmaceuticals is providing both funding and INOmax — nitric oxide gas for inhalation — for the study.
Patients are being enrolled in a Phase 2 trial at Beaumont Hospital in Royal Oak, Michigan, to test a combination of naltrexone and ketamine for treating COVID-19. Researchers will assess whether reducing inflammation with the combo therapy may lessen the severity of COVID-19 symptoms.
AstraZeneca and the University of Oxford are collaborating on developing a potential vaccine against COVID-19 to be developed and distributed globally. The potential vaccine, called ChAdOx1 nCoV-19, is being developed by the University of Oxford and will be manufactured and distributed by AstraZeneca.
► April 29, 2020
German regulatory authority Paul-Ehrlich-Institut approved a Phase 1/2 clinical trial for BioNTech and Pfizer‘s BNT162 vaccine program, which is testing four mRNA vaccine candidates to prevent COVID-19. In the first phase of the trial, researchers will test the vaccines in 200 healthy volunteers ages 18 to 55 to determine the optimal dose. The second part will include participants at a higher risk of severe COVID-19.
Asthma medication MN-166 (ibudilast) will be tested in a clinical trial to assess its potential in treating acute respiratory distress syndrome caused by COVID-19. The trial is a collaboration between Yale University and pharmaceutical company MedicNova.
A trial called STOP-COVID19 is expected to start recruiting up to 300 hospitalized patients with COVID-19 in the U.K. in May to test the experimental treatment brensocatib. Insmed, which is developing the treatment for bronchiectasis and other inflammatory diseases, will provide funding and the medication for the trial, which is sponsored by the University of Dundee.
A new trial funded by Amazon and run by Columbia University will assess whether plasma (the liquid portion of the blood devoid of cells) obtained from COVID-19 survivors can be used to prevent SARS-CoV-2 infections or treat COVID-19. The trial aims to recruit 450 people who have been in close contact with COVID-19 patients such as healthcare workers as well as intensive care unit patients.
Astra Zeneca will test the diabetes treatment Farxiga (dapagliflozin) in a trial to assess its potential to decrease the risk of death from serious complications and organ failure in COVID-19 patients. The trial, which is a collaboration with Saint Luke’s Mid America Heart Institute, will enroll 900 participants in the U.S. and European countries that are experiencing high rates of COVID-19 cases.
An experimental treatment by Vivacelle Bio will be made available for compassionate use in COVID-19 patients. The experimental treatment, called VBI-S, is currently being tested in a Phase 2 trial (NCT04257136) people with reduced blood circulation due to sepsis.
Quest Diagnostics started offering an antibody testing service for COVID-19 on blood samples. The antibody test, intended for healthcare providers, can determine whether a person has antibodies in their blood against SARS-CoV-2, meaning they have been exposed to the virus and may have some level of immunity against it.
► April 22, 2020
Biogen, Broad Institute, and Partners HealthCare are launching a consortium to build and share a COVID-19 biobank. The biobank will contain blood samples of Biogen employees willing to participate in the project who contracted and have recovered from COVID-19. People identified as close contacts of those individuals are also eligible to participate regardless of whether they were confirmed to have COVID-19. The biobank will help scientists understand why some people infected with SARS-CoV-2 become seriously ill while others do not even show any symptoms. A better understanding of the biology of the virus and the response the human body has to it will help speed the quest for potential vaccines and treatments.
Alexion is planning a Phase 3 trial testing Ultomiris (ravulizumab-cwvz) for treating severe COVID-19. The global trial will include approximately 270 hospitalized patients who have severe pneumonia or acute respiratory distress syndrome. Ultomiris is FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS).
In the coming weeks, Novartis is planning to start enrollment for its randomized Phase 3 trial testing hydroxychloroquine in hospitalized COVID-19 patients. An estimated 440 patients will be recruited across more than a dozen U.S. sites.
Sinovac has launched a randomized Phase 1 trial in China to test its vaccine candidate against COVID-19. The first group of an estimated total of 144 healthy adults have already been given the first dose of two doses of the experimental vaccine.
The FDA authorized a saliva test for emergency use to diagnose COVID-19. The test was developed by Rutgers University in collaboration with other groups. The test can only be used in a healthcare setting and is not available to purchase for home testing.
LabCorp has received emergency use authorization from the FDA for the first diagnostic test using samples collected from people at home. The at-home kit includes a special cotton swab to collect a sample from the individual’s nose. The sample is then mailed in an insulated package to a LabCorp lab. The products contained in the LabCorp collection kit are the only ones authorized for at-home use at this time.
► April 15, 2020
Biohaven Pharmaceuticals will soon start a Phase 2 clinical trial to test intranasal vazegepant in treating lung complications caused by COVID-19. The trial will run in collaboration with Thomas Jefferson University and other institutions.
The FDA has cleared a Phase 2 trial that will test the safety and efficacy of Hope Biosciences’ adipose-derived mesenchymal stem cells to provide immune support against COVID-19. The trial will enroll an estimated 100 front-line healthcare workers and first responders and will test three doses of cells over 14 weeks.
Vaxil has completed the first preclinical experiment testing its COVID-19 vaccine candidate. According to the results, the vaccine candidate showed a favorable immune response in healthy donor blood cells. The company has now begun the next set of experiments to better understand the immune responses and determine dosing, with additional experiments planned.
Sanofi and GlaxoSmithKline are partnering on developing an adjuvanted COVID-19 vaccine. Sanofi is providing its S-protein COVID-19 antigen, based on a recombinant RNA technology that created an exact match to proteins found on the surface of the virus. GSK will contribute its pandemic adjuvant technology, which is intended to boost the immune response and may lead to a stronger and longer-lasting effect than the vaccine alone. The companies are aiming to launch a Phase 1 trial in the second half of this year.
► April 8, 2020
(high-dose inhaled nitric oxide therapy) can now be tested in patients infected with SARS-CoV02 as part of a Phase 2 clinical trial () that began in 2017 to assess its effects in treating difficult lung infections. and , developers of Thialonax, on April 1 that their joint pilot trial was cleared by the . The trial will now be able to recruit participants infected with SARS-CoV-2 at Vancouver Coastal Health Authority facilities to test the therapy’s safety and effectiveness in treating COVID-19.
The FDA a randomized, double-blind, placebo-controlled Phase 3 trial () to evaluate the safety and efficacy of plus standard of care in hospitalized adults with severe COVID-19 pneumonia. Actemra is an anti-rheumatoid medication by that is also being evaluated in a as a potential treatment for COVID-19.
A Phase 3 trial called RUXCOVID is to evaluate the safety and efficacy of in COVID-19-associated . The medication was developed by and is sold under the brand-name Jakafi for , , and . Two more trials will test ruxolitinib in treating severe acute respiratory syndrome (SARS) caused by COVID-19 () and COVID-19 pneumonia (). The trials will take place in Mexico and in Canada respectively, but are not yet recruiting patients.
Researchers are working on a new RNA-based immunotherapy to treat COVID-19. The potential treatment would be inhaled by patients and produce therapeutic antibodies in the lungs. and to start trials testing the potential treatment by the end of the year.
► April 1, 2020
Several tests for diagnosing COVID-19 have now been granted emergency use authorization (EUA) from the FDA. As of March 31, the Advanced Medical Technology Association estimated that 17 tests had received EUAs, with more in the works. The same day, Bodysphere announced it was rolling out a test that returned results within two minutes, saying it was granted an EUA, but the FDA later refuted that claim. The test at this point has not received any FDA authorization.
The FDA issued a warning last week that it has not authorized any test for people to use at home for COVID-19 and that people should be aware of such fraudulent tests. It also provided a list of fraudulent COVID-19 products including those that claim to prevent or treat the disease.
The agency also announced the creation of an emergency program called the Coronavirus Treatment Acceleration Program to assist in the development of treatments for COVID-19. According to the FDA, as of March 31, it is reviewing 10 therapies already in trials and 15 others in preclinical stages.
Sandoz’s malaria treatment hydroxychloroquine sulfate and Bayer Pharmaceuticals’ chloroquine phosphate have been granted an EUA by the FDA for the treatment of COVID-19. Both companies have donated supplies of the medications to the U.S. Department of Health and Human Services for use. Although clinical trials are needed to prove their efficacy in treating COVID-19, these therapies have shown some benefit in the lab and clinic, according to anecdotal evidence.
Among the trials recently launched for COVID-19 are a global Phase 2/3 trial (NCT04315298) testing rheumatoid arthritis treatment Kevzara (sarilumab) and a U.K.-based Phase 2 trial testing antiviral SNG001, an inhaled formulation of interferon-beta-1a. The first patients have already been treated in both trials. Another Phase 2/3 trial (NCT04315298) testing Kevzara is recruiting an estimated 400 participants in the U.S.
Johnson & Johnson announced plans to start a Phase 1 trial by September to test its vaccine candidate Ad26 SARS-CoV-2 against COVID-19. If the trial is successful, the first batch of the vaccine could be available in early 2021 for emergency use, according to the company.
► March 27, 2020
The CDC has developed a diagnostic panel for use by CDC-qualified laboratories in the U.S. and made available under an emergency use authorization (EUA) from the FDA
Other new tests include Roche Diagnostics’ cobas SARS-CoV-2 test, also granted an EUA, and the U.S. Department of Health and Human Services is funding the development of two other diagnostic tests that can detect the presence of SARS-CoV-2 within one hour.
The National Institute of Allergy and Infectious Diseases is sponsoring a randomized, controlled Phase 2 trial in the U.S. to evaluate the safety and efficacy of the broad-spectrum anti-viral treatment remdesivir by Gilead Sciences to treat the disease. Gilead has also launched two global Phase 3 trials to evaluate remdesivir’s safety and efficacy in adults with COVID-19.
Other treatments being investigated for COVID-19 include a novel mRNA-1273 nanoparticle-encapsulated vaccine (NCT04283461), thalidomide (NCT04273581), sildenafil (NCT04304313), eculizumab (NCT04288713), recombinant human interferon-alpha 1 beta (NCT04293887), bevacizumab (NCT04305106), and antibodies from cured patients (NCT04264858), among others.
Researchers are also looking at new synthetic biology approaches by using self-assembling nanoparticles coated with viral antigens that can precisely target SARS-CoV-2. This approach can potentially overcome some of the limitations of conventional vaccines such as short shelf-life and viral evolution.