A publication from Friday provides new details on an antiviral drug for Covid-19 that received an emergency use authorization from the Food and Drug Administration at the start of this month.
Data from the National Institute of Allergy and Infectious Diseases’ Phase III study of Gilead Sciences’ remdesivir were published in the New England Journal of Medicine, giving a sense of not only the drug’s safety and efficacy, but its limitations and where it might find the greatest usefulness in patients infected with SARS-CoV-2. In particular, they wrote that the study findings highlight a need to identify and start Covid-19 patients on antiviral treatment before they progress to requiring mechanical ventilation.
The FDA granted its EUA for remdesivir in patients hospitalized with Covid-19. The authorization followed the release of data from the 1,063-patient, randomized and placebo-controlled NIAID study, as well as data from an uncontrolled Phase III study sponsored by Foster City, California-based Gilead.
The published data include 1,059 patients, of whom 538 received the drug, while 521 received placebo. They show that among patients who received the drug, the median recovery time was 11 days, compared with 15 for those in the placebo arm. In terms of mortality, the number of deaths in the remdesivir arm was numerically lower than in the placebo arm – with rates of 7.1% versus 11.9%, respectively – but the result was not statistically significant.
The study authors found that the drug was most beneficial among patients who required oxygen, which they wrote was most likely due to the larger sample size, while there were wide confidence intervals among patients who did not receive oxygen, received high-flow oxygen or were on ventilators. They were unable to estimate recovery time for patients on ventilators, possibly because the follow-up time was too short. The severe pulmonary symptoms have been attributed to inflammation caused by Covid-19, and to that end several clinical trials are investigating the use of anti-inflammatory drugs in the disease.
“We are pleased that the findings from the NIAID trial of remdesivir in hospitalized patients with advanced Covid-19 have been published in a peer-reviewed medical journal,” Gilead chief medical officer Merdad Parsey said in a statement. “These findings support the use of remdesivir in this population, with the largest benefit observed among individuals who required oxygen supplementation but were not mechanically ventilated.”
But finding patients with less severe disease could be difficult, as it’s often only when those problems start that they end up being hospitalized – which itself is a requirement for using the drug. That is one of the reasons why Gilead’s moderate-disease study has reportedly had a harder time accruing patients than the severe-disease one.
Photo: Ulrich Perrey, Pool/AFP, via Getty Images