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With so much uncertainty, the remdesivir-watchers were waiting anxiously for final results from the NIAID trial, which were not expected until the end of May. “It’s reassuring that 50–60% of patients are discharged from the hospital, but this is a disease that mostly gets better anyway.” “I’m just very annoyed by all of these non-controlled studies,” says Geoffrey Porges, a biotechnology analyst for the investment bank SVB Leerink in New York City. In the rush to find therapies to combat COVID-19, small clinical trials without control groups have been common. Small trialsįast-flowing, conflicting information on remdesivir in the past few weeks has left people reeling. “There is a lot of focus on remdesivir because it’s potentially the best shot we have,” says virologist Stephen Griffin at the University of Leeds, UK. Nevertheless, onlookers are hopeful that the large NIAID trial provides the first glimmer of promise in a race to find a drug that works against the coronavirus, which has infected more than three million people worldwide. But that trial was stopped early owing to difficulty in enrolling participants as the outbreak subsided in China. Also on 29 April, a smaller trial run in China announced that it had found 1 no benefits from remdesivir when compared with a placebo. But the study lacked a placebo-controlled arm, making the results difficult to interpret. The drug’s maker, Gilead Sciences of Foster City, California, announced on the same day that in its own trial, more than half of 400 participants with severe COVID-19 had recovered from their illness within two weeks of receiving treatment.
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The news comes after weeks of data leaks and on a day of mixed results from clinical trials of the drug. Distribution of the drug in the United States will be under government control. The FDA’s authorization is not a final drug approval, and can be revoked when the conditions required for emergency use are no longer in effect. Fauci added that remdesivir would become a standard treatment for COVID-19. The shortened recovery time, however, was significant, and was enough of a benefit that investigators decided to stop the trial early, he said, to ensure that those participants who were receiving placebo could now access the drug. There were also fewer deaths among trial participants who received the drug, he said, but that trend was not statistically significant. “What it has proven is that a drug can block this virus.” “Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept,” Fauci said. On 29 April, Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID), announced that a clinical trial in more than 1,000 people had showed that those taking remdesivir recovered in 11 days on average, compared with 15 days for those on a placebo. Remdesivir interferes with the replication of some viruses, including SARS-CoV-2, which is responsible for the current pandemic. On 1 May, the US Food and Drug Administration (FDA) granted an ‘emergency use authorization’ for clinicians to use the drug, called remdesivir, which is administered intravenously, in hospitals for people with severe COVID-19. Credit: Zhang Yazi/China News Service via GettyĪn experimental drug - and one of the world’s best hopes for treating COVID-19 - could shorten the time to recovery from coronavirus infection, according to the largest and most rigorous clinical trial of the compound yet. Coronavirus causes severe respiratory illness in some people.