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WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total trial enrollment is being affected during this pandemic. The four countries showing the largest amount of clinical trial restart activity in the past week are the U.S., Israel, Poland and Ukraine.
21% of sites are now open to enrollment of new participants, an increase of 10 percentage points in the last three weeks. We anticipate this trend to continue as countries reopen.
Investigator restart comes in two forms – being open to enrollment of ongoing studies, and being open to enrollment of both ongoing and new trials. Very early data show that of the global sites that are restarting enrollment activity, 37% are open only to restarting ongoing trials, while 57% are open to enrollment of ongoing and new trials. 6% of sites are only open to new trials at this time.
That means that more than a third of investigators are still not willing to take on new trials that have been waiting to start since the COVID-19 outbreak. We will have more information on this next week.
News provided by WCG FDAnews and WCG CenterWatch
Full NIH Data on Remdesivir Supports Early Positive Report
NIH Friday confirmed preliminary remdesivir trial data showing that the drug delivered a median recovery time of 11 days compared with 15 on placebo, establishing it as the standard of care for patients with moderate to severe disease.
CanSino Biologics’ COVID-19 Vaccine Shows Promise in Humans
A leading COVID-19 vaccine candidate has shown promise as being safe and effective in humans and produced an immune response against the coronavirus, according to preliminary data from a phase 1 trial of 108 healthy adults in China.
Large Study Links Hydroxychloroquine to Increased Risk of Death
Another study — the largest to date — has shown that anti-malaria drugs hydroxychloroquine and chloroquine have no benefit in treating COVID-19, in fact have a negative effect on patient survival and are associated with an increase in ventricular arrhythmias.
STERIS Gets Emergency Use Authorization for Steam Sterilizer
Currently, there are no FDA-approved devices for decontaminating N95 respirators.
New Reagent Available to Support COVID-19 Diagnostics
The reagent contains coronavirus genetic material used to confirm that a test is working correctly.
IMV Selects COVID-19 Vaccine Candidate for Human Trials
IMV expects to initiate a phase 1 trial testing the vaccine in 84 healthy volunteers this summer.
Large Hydroxychloroquine Study Gets Under Way
Enrollment for a large, global trial of chloroquine and hydroxychloroquine for the prevention of COVID-19 is getting under way in the United Kingdom.
TriNetX, Harvard Pilgrim Health Care Institute to Monitor COVID-19 Drug Usage
TriNetX is partnering with the FDA’s Sentinel Operations Center at the Harvard Pilgrim Health Care Institute (HPHCI) to monitor priority drugs used for treating hospitalized COVID-19 patients.
FDA Adds Morphine, Epinephrine to COVID-19 Compounding List
The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic.
AstraZeneca Receives $1.2 Billion BARDA Contract for COVID-19 Vaccine
AstraZeneca has nabbed an HHS contract worth up to $1.2 billion to speed development and production of the University of Oxford’s promising COVID-19 vaccine candidate. The deal also would lock in the distribution of 300 million doses of the vaccine for the U.S.
BioMérieux’s COVID-19 Antibody Tests Obtain CE Mark
The presence of antibodies in a patient means that they likely had COVID-19 at some point and may suggest they have some degree of immunity.
Fujifilm Begins Research on AI Tech for COVID-19 Pneumonia
The company is involving local Japanese medical institutions in its project, beginning with Yokohama’s Kanagawa Cardiovascular and Respiratory Center.
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.