More than 70 clinical trials have registered with the Food and Drug Administration.
With coronavirus infections and deaths mounting in the United States, the race to find treatments and vaccines is accelerating. There are now 72 registered clinical trials ongoing in the U.S. and abroad, according to the Food and Drug Administration. Here’s a rundown of how this process is taking shape, and the key results expected in the coming months.
Remdesivir
Gilead’s experimental antiviral drug was developed to treat Ebola but failed for that purpose. Now, remdesivir has been repositioned as a potential coronavirus therapy. The hype around the drug has grown after the New England Journal of Medicine published promising but anecdotal results from compassionate use and STAT News reported on leaked data from a clinical trial in Chicago. The first official results from clinical trials are expected by the end of the month.
Gilead is running two Phase III trials in the U.S., Asia and Europe. One aims to enroll 6,000 severely ill patients, while the second is seeking 600 moderately ill participants. Both are “open label,” meaning that both doctor and patient know which treatment the patient is receiving. The severe trial is expected to report results in late April, with data from the moderate trial coming in late May.
The National Institute of Allergy and Infectious Diseases — the agency run by Anthony Fauci — has launched the first randomized, controlled trial of remdesivir, enlisting about 1,060 patients worldwide. Results are expected in late May.
Two Chinese trials were halted this month because of a lack of enrollment, purportedly due to a lack of patients with Covid-19 as China’s outbreak wanes.
Outside of the trials, Gilead is still allowing patients to access the intravenous drug via a compassionate use program. It’s donating 1.5 million doses — enough to treat more than 140,000 patients — for use in clinical trials and compassionate use programs…
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