Remdesivir, an experimental antiviral drug developed by Gilead Sciences as a treatment for Ebola, has shown clinical benefit in a US clinical trial with 1,063 COVID-19 patients. While hospitalized COVID-19 patients receiving a placebo took an average of 15 days to recover from the disease, patients taking remdesivir recovered in an average of 11 days—a reduction of 31 percent.
“Remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery,” reads a statement posted yesterday (April 29) by the National Institute of Allergy and Infectious Disease (NIAID). “More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report.”
The study did not conclusively demonstrate that the drug reduces mortality from COVID-19, although the NIAID statement noted that statistically insignificant results from the trial were suggestive of a survival benefit: the group receiving the drug had a mortality rate of 8 percent, compared to 11.6 percent for the group receiving a placebo.
Announcing the findings from the Oval Office, NIAID Director Anthony Fauci said that the trial had “proven . . . that a drug can block this virus,” the Associated Press reports. He added that that “this will be the standard of care,” and that other potential treatments will be combined with or compared to remdesivir from now on.
The findings of the NIAID study contrast with the results of a smaller trial of remdesivir carried out in China that was published yesterday in the peer-reviewed journal The Lancet. That study, a randomized, placebo-controlled trial of 237 COVID-19 patients across multiple centers, found that “remdesivir was not associated with statistically significant clinical benefit,” although the data did show some reduction in time to recovery in patients taking the drug. The paper also reports that administration of the drug had to be stopped in several patients due to side effects.
Data from a Gilead-sponsored trial carried out at the University of Chicago, leaked and subsequently circulated this month by STAT News and other outlets, also showed apparently faster-than-normal recovery in COVID-19 patients taking remdesivir. But the absence of a control arm in that study made the findings difficult to interpret, and the University of Chicago told STAT in a statement at the time that “drawing any conclusions at this point is premature and scientifically unsound.”
News of the drug’s apparent success has sent Gilead’s stock prices soaring since mid-April, with a jump of more than 11 percent in premarket trading yesterday morning. However, some researchers have expressed concerns about the way information about the drug trials has been made public.
Noting a lack of detail in Fauci’s announcement yesterday, Steven Nissen, chief academic officer at the Cleveland Clinic, tells Reuters, “I want to see the full data. I want to understand the statistics. I want to understand the benefit and risk. I want to understand the structure of the study, and all of it. . . . Am I encouraged from what I’ve heard? Yes, I’m encouraged. But I want to get a full understanding of what happened here, and not get it via a photo opportunity from the Oval Office.”
Fauci tells Reuters that the decision to make the trial findings public was partly driven by concerns that parts of the study would be leaked anyway, and could have led to public confusion. “I would love to wait to present it at a scientific meeting,” he adds, “but it’s just not in the cards when you have a situation where the ethical concern about getting the drug to people on placebo dominates the conversation.”