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Monitor the progress of clinical trials for COVID-19 treatments and vaccines, leveraging data from the WCG Knowledge Base™.
The WCG Trial Insights series brings you weekly insights on trial activity throughout the COVID-19 crisis, based on the extensive services we provide to life science clients and supported by our proprietary and powerful WCG Knowledge Base™.
Need help interpreting critical data to navigate the impact of COVID-19 on trials and sites? We leverage insights and benchmark data from the WCG Knowledge Base to guide best practices for trial performance during this unprecedented time.
Nucleic Acids dominate the agents being studied in COVID-19 vaccine trials (40%), followed by Immune Mediators (30%). The mRNA-based vaccine platform being used in some vaccines is a novel one, not used in any currently approved vaccines.
WCG continues to track the progress of global interventional industry-sponsored COVID-19 trials that have been initiated so far this year – now numbering 412. Of those, 24 have been reported as complete, with five completing in the past three weeks since we last reported this data. To date, four studies have reported meeting their primary endpoint, with another four reporting they did not meet their endpoint. Notably, 127 studies are still planned for initiation in 2020, so this data will continue to reflect additional activity.
According to industry-reported data tracking planned study starts and actual study starts so far this year (including COVID-19 and non-COVID-19 trials), WCG is tracking more than 1,800 studies that were originally planned to initiate by August and are still showing a status of planned and yet-to-be initiated as of September. Though overall 2020 study start volumes are down versus 2019, more than 4,400 trials were initiated from January through August. We’ll continue to track this data in Q4 and beyond, as sponsors navigate uncertainty and update trial status and plans accordingly.
News provided by WCG FDAnews and WCG CenterWatch
Eli Lilly Partners With Amgen to Manufacture Potential COVID-19 Antibody
Eli Lilly has entered into a global partnership with Amgen to increase supply capacity for Eli Lilly’s neutralizing antibodies as a treatment for COVID-19 patients.
NIH Launches Trial of Rigel’s Fostamatinib for COVID-19 Patients
The National Institutes of Health (NIH) has launched a phase 2 clinical trial of Rigel Pharmaceuticals’ fostamatinib for the treatment of hospitalized COVID-19 patients.
Moderna Will File for Emergency Approval if COVID Vaccine is 70 Percent Effective
Moderna has said its COVID-19 vaccine must be at least 70 percent effective before it will file for an Emergency Use Authorization (EUA).
BioNTech Buys German Manufacturing Site From Novartis for COVID-19 Vaccine
Co-developers Pfizer and BioNTech are preparing for a global roll-out of the vaccine as soon as it receives an Emergency Use Authorization or approval.
HHS Releases COVID-19 Vaccine Distribution Plan
Distribution of a COVID-19 vaccine in the U.S. will begin within 24 hours of getting the go-ahead from regulators, under a new distribution plan unveiled yesterday by HHS.
FDA Will Heavily Investigate AstraZeneca Vaccine Safety Issue, Hahn Says
Health regulators abroad have begun giving the OK for AstraZeneca to resume its phase 3 COVID-19 vaccine trial following a single unexplained patient illness, but the FDA has still not cleared the trial to start back up, with FDA Commissioner Stephen Hahn saying the agency will engage in “very significant…
Eli Lilly Antibody Cuts Hospitalization Rates in COVID-19 Patients
A mid-stage trial of Eli Lilly’s neutralizing COVID-19 monoclonal antibody LY-CoV555 found that the drug reduced the risk of hospitalization in mild-to-moderate COVID-19 patients by 72 percent compared to a placebo.
Pfizer Reports Only Mild-to-Moderate Side Effects of COVID-19 Vaccine in Late-Stage Trial
Pfizer reported early safety data yesterday from its phase 3 COVID-19 vaccine trial, saying the vaccine prompted mostly mild to moderate adverse reactions in patients.
Dr. Reddy’s Enters Research, Distribution Deal for Russia’s Sputnik V Vaccine
Indian pharmaceutical company Dr. Reddy’s will assist in phase 3 clinical trials and distribution in India for Russia’s COVID-19 vaccine, Sputnik V, the company and Russian government announced.
Galera Therapeutics Doses First Patient in Phase 2 Trial of Avasopasem Manganese for COVID-19
Avasopasem manganese is currently under development for radiation-induced severe oral mucositis, a common side effect of chemotherapy.
EuroBio Scientific Earns CE Mark for COVID-19/Flu/RSV Test
The test can be used for initial diagnosis or for confirming the results of rapid tests with lower performance, such as antigenic tests, the company said.
NIH Troubled by Safety Issue in AstraZeneca’s Phase 3 Vaccine Trial
The National Institutes of Health (NIH) is deeply concerned that an unexplained patient illness under review in AstraZeneca (AZ)’s phase 3 COVID-19 vaccine trial could throw the promising candidate off course, and the NIH has opened its own investigation into the issue, an NIH clinical director has disclosed.
As we navigate COVID-19 together, our clinical trial experts are engaged to address the biggest questions. To submit a topic or question, use the form at the bottom of the page.
Please note: protocol-specific questions for studies under the oversight of a WCG IRB should be submitted through your IRB contact person, not through this form.
Disclaimer: All information available on this site is intended for your general knowledge and is not for the purpose of providing regulatory advice, medical advice, or a substitute for institutional review board review. You should not use this information to determine compliance with any applicable laws or regulations governing institutional review boards and human subjects research.