“For example, the primary end point of the NIAID-designed trial was met and will provide more information on the benefit of the drug,” Adalja concluded.
Remdesivir is a broad-spectrum antiviral that has shown promise in fighting many different dangerous viruses, including the COVID-19 coronavirus, MERS and SARS, Gilead said. It is designed to interfere with viral replication.
In the study from China, 237 severely ill patients were randomly chosen to receive either remdesivir or a placebo between Feb. 6 and March 12 at 10 hospitals in Hubei, the province that includes Wuhan. Researchers had aimed to recruit 453 patients, but a steep decline in COVID-19 cases prevented them from reaching that goal.
Those who received remdesivir did not receive any apparent benefit over the placebo, regardless of when treatment started, said the research team led by Dr. Bin Cao from China-Japan Friendship Hospital and Capital Medical University in China.
“Our trial found that intravenous remdesivir did not significantly improve the time to clinical improvement, mortality, or time to clearance of virus in patients with serious COVID-19 compared with placebo,” the report concluded.
The early results reported Wednesday by Gilead are based on an initial phase of the U.S.-led clinical trial involving 397 patients with severe COVID-19 assigned to receive either 5 or 10 days of remdesivir. There was no mention of a control or placebo group.
At least half of patients treated with a five-day dose of the drug improved, and more than half were discharged from the hospital within two weeks, Gilead reported.
More than 64% of the patients who received the shorter treatment course were discharged, compared with 54% of the group treated for 10 days.
The trial also showed that people who got the drug soon after they developed symptoms did better than those who got it later.
This matches with what doctors on the front lines have learned regarding COVID-19 treatment, Glatt said — namely, delaying the use of antivirals gives the coronavirus more time to damage the body.
“If we only save antivirals for the patients who have already deteriorated so much, it may not be the virus we’re treating anymore. It’s the underlying damage, and I’m not sure that any viral treatment is going to make a difference if the lungs are damaged and the immune system cascade has reached a point where you’re seeing toxicity,” Glatt explained.