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NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.
Preliminary results of two clinical trials on the use of Gilead Sciences investigational antiviral remdesivir announced on April 29, 2020 indicate the drug may be effective as a treatment for COVID-19 disease.
The National Institutes of Health (NIH) reported on preliminary data that showed patients with advanced COVID-19 and lung involvement who received remdesivir had a 31% faster recovery time compared with those who received a placebo. The patients receiving remdesivir had a median time to recovery of 11 days compared with 15 days for patients who received placebo. Results also suggested a survival benefit, NIH reported in a press statement, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group.
The study, sponsored by the National Institute for Allergy and Infectious Diseases, was launched on Feb. 21, 2020, involved 1063 hospitalized patients, and was conducted at 47 sites in the United States and 21 in Europe and Asia. Detailed study results will be released in an upcoming report, NIH said in a press statement.
On April 17, 2020, NIH reported animal study results that showed early treatment with remdesivir significantly reduced clinical disease and damage to the lungs of rhesus macaques infected with SARS-CoV-2, the coronavirus that causes COVID-19.
Clinical trials for remdesivir have been closely followed as healthcare providers anxiously seek treatments for patients diagnosed with COVID-19 disease. Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity in vitro and in vivo in animal models against multiple viral pathogens, including Ebola, Marburg, MERS, and SARS. Gilead reports that the company has demonstrated in vitro that remdesivir is active against the virus that causes COVID-19. Multiple ongoing Phase III trials are in progress to evaluate the safety and efficacy of remdesivir for the treatment of COVID-19.
A separate study conducted by Gilead Sciences showed patients receiving a 10-day treatment course of remdesivir in an open-label, Phase III study achieved similar improvement in clinical status compared with those taking a five-day treatment course. No new safety signals were identified with remdesivir across either treatment group, Gilead reported.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, chief medical officer, Gilead Sciences, in a press statement. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
The purpose of the study was to determine whether a five-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies. Secondary objectives included rates of adverse events and other measures of clinical response, Gilead reported in the press statement. The company said it would submit the full data for publication in a peer-reviewed journal in the coming weeks.