Preliminary data from a clinical trial led by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) showed that Gilead Sciences’ remdesivir led to faster recovery in Covid-19 patients.
The ACTT trial, which involved 1063 hospitalised patients with advanced Covid-19 and lung involvement, compared the experimental antiviral drug to placebo.
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An interim analysis by the independent data and safety monitoring board (DSMB) found that remdesivir performed better on the primary endpoint of ‘time to recovery’ when compared to placebo.
Results showed a 31% faster time to recovery in patients treated with Gilead’s drug versus placebo. The median time to recovery was 11 days versus 15 days, respectively.
NIH also noted a survival benefit, where remdesivir group had 8% mortality rate compared to 11.6% with placebo.
Commenting on the trial data, NIH said: “More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report.
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By GlobalData“As part of the US Food and Drug Administration’s commitment to expediting the development and availability of potential Covid-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.”
Furthermore, Gilead has reported top-line data from the open-label, Phase III SIMPLE trial of remdesivir.
The trial assessed five-day and ten-day dosing durations of the drug in hospitalised patients suffering from severe Covid-19 manifestations .
According to the top-line results, patients on a ten-day treatment course experienced an improvement in clinical status that was similar to those on a five-day dosing course.
The investigators did not report any new safety signals in either treatment group. The drug was generally well-tolerated in both the treatment arms.
The most common adverse events in more than 10% of participants in either group were nausea and acute respiratory failure.
Results from the second SIMPLE trial in patients with moderate Covid-19 manifestations are expected to be available by the end of next month.
