Worldwide, patients with COVID-19 have expressed great interest in joining clinical trials of remdesivir that have opened in hospitals over the last few weeks. The National Institutes of Health (NIH) is expanding its study of the antiviral drug, which initially sought to enroll 440 patients, while Gilead Sciences, remdesivir’s manufacturer, is launching its own studies as well.
There are no medications approved to treat coronavirus. Jag Singh, MD, PhD, Chair of Cardiology at Massachusetts General Hospital who contracted the virus, told AP News “it did not even cross my mind once to say ‘no’” when he received an offer to test the experimental drug.
Remdesivir is designed to interfere with an enzyme that reproduces viral genetic material. In animal studies of SARS and MERS, when administered early enough, remdesivir helped prevent infection and reduce severity of symptoms.
On a case-by-case emergency basis, Gilead has given the drug to more than 1,700 patients and will expand access once the company has data proving safety and efficacy. For now, the company is providing remdesivir for free. Gilead CEO Dan O’Day says the company hopes to produce 500,000 treatment courses by October 2020 and more than 1 million by the end of the year.
Gilead has launched two trials for patients who are hospitalized in the U.S., Asia, Europe, and elsewhere, one of which compares 5 days of treatment with 10 days of treatment in patients who are severely ill with COVID-19. The other study compares those two treatment options to standard care alone in patients who are moderately ill.
The NIH study, currently underway in the U.S., Japan, Korea, and Singapore, compares remdesivir with placebo infusions.
Sources: AP News, April 6, 2020; Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment on ClinicalTrials.gov; Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19) on ClinicalTrials.gov.