One vial of the drug Remdesivir lies during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany on April 8, 2020, amidst the new coronavirus COVID-19 pandemic. (Photo by Ulrich Perrey / POOL / AFP) (Photo by ULRICH PERREY/POOL/AFP via Getty Images)
In a report published Friday, researchers from biopharmaceutical company Gilead Sciences said that COVID-19 patients receiving its antiviral drug remdesivir experienced lower mortality rates and better recovery times compared to those not getting the treatment.
The researchers compared 312 people hospitalized for COVID-19 and who received remdesivir to 818 people with similarly severe cases who were treated with standard of care, but did not need mechanical ventilation to breathe. Compared to the people in the latter group, those getting remdesivir showed a 62% lower risk of mortality during the study period. Furthermore, about 75% of patients receiving remdesivir recovered by day 14 after hospitalization, compared to 59% of those not getting the drug.
The findings were presented at the International AIDS Conference’s virtual COVID-19 conference, which Gilead is co-sponsoring.
The analysis did not follow the rigorous gold standard of comparing an experimental treatment group to a control group within the same study, a method that ensures the two groups are similar as possible and better accounts for potentially confounding factors. A previous remdesivir study that met such criteria, conducted by the National institute of Allergy and Infectious Diseases and reported in late April, showed that people taking remdesivir had a shorter recovery time. Given the urgency of finding a treatment during a quickly-worsening pandemic, the results prompted the NIH to decide that future studies of the drug (like those testing it in combination with other drugs, including anti-inflammatories) would not need a placebo group.
Gilead’s analysis is the next-best thing to a randomized placebo-controlled trial, and the company’s scientists acknowledge that more studies are needed to confirm the reduction in mortality. “To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir,” Gilead Sciences Chief Medical Officer Merdad Parsey said in a statement.
Gilead also reported additional data showing that remdesivir provided similar benefit to people of racial and ethnic groups that seem to be more vulnerable to COVID-19 and its consequences. In another analysis of people who received the drug early in the pandemic (under the company’s compassionate use program), the scientists found that children and pregnant women taking the drug had similar benefits in improved oxygen measures.
Remdesivir is not yet approved by the Food and Drug Administration (FDA), but the agency issued an Emergency Use Authorization (EUA) for it on May 1, which allows doctors to request the drug for severely ill patients.
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