- NIH-Sponsored Study Will Evaluate Whether Experimental Drug Remdesivir Is Safe and Effective
- The antiviral drug remdesivir has shown promise in counteracting SARS and MERS
Cedars-Sinai has joined an international effort to test an experimental antiviral drug as a potential treatment for COVID-19 (coronavirus). The institution expects to enroll its first clinical trial participant this week.
Cedars-Sinai is among dozens of sites around the world participating in the clinical trial, sponsored by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH). The trial is evaluating remdesivir, an investigational drug developed by the biopharmaceutical company Gilead Sciences Inc., based in Foster City, California.
Remdesivir is in a class of antiviral drugs designed to inhibit an enzyme that certain viruses, including the one that causes COVID-19, require to replicate themselves. The drug is not approved by the Food and Drug Administration (FDA) for marketing to the general public. At present, there are no specific FDA-approved therapeutics to treat people with COVID-19.
In animal studies, remdesivir has shown promise in counteracting other types of coronaviruses that caused two prior outbreaks of deadly respiratory diseases, known as SARS and MERS, according to Victor Tapson, MD, Cedars-Sinai site director for the NIH trial.
In a few anecdotal cases, significant improvement has been reported in COVID-19 patients who were administered remdesivir, said Tapson, who directs clinical research at the Women’s Guild Lung Institute at Cedars-Sinai. But individual cases are not enough to prove the drug works, he explained.
“We need randomized, controlled studies to verify that remdesivir is both safe and effective,” Tapson said. “That is why this clinical trial is so important.”
Cedars-Sinai plans to enroll up to 30 hospitalized COVID-19 patients for the trial. One group will receive 200 milligrams of remdesivir administered intravenously on the first day, followed by a once-a-day maintenance dose of 100 milligrams for the duration of hospitalization, up to 10 days. The control group will receive injections of a placebo drug that appears identical to remdesivir but lacks the active ingredient.
At the end of the trial period, the investigators will compare outcomes of the treatment and control groups on clinical severity, hospitalization and mortality—and also evaluate the drug’s safety.
Besides Tapson, the Cedars-Sinai site team for the trial includes Jonathan Grein, MD, director of Hospital Epidemiology; Fayyaz Sutterwala, MD, PhD, director of the Infectious Diseases Division and professor of Medicine; Aaron Weinberg, MD, assistant professor of Medicine, from the Pulmonary Embolism Response Team; research nurse Susan Jackman; and clinical research coordinators Niree Hindoyan, Gwendolyn Weissberg and Katherine Isip.
Tapson emphasized that the trial involves many contributors, including critical care and infectious diseases experts, pulmonologists, anesthesiologists, critical care nurses and pulmonary fellows and residents.
In an NIH news release announcing the multicenter clinical trial, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and a member of the U.S. Coronavirus Task Force, stressed the trial’s significance.
“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” Fauci said. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”