Leading COVID-19 hope remdesivir fails to provide clinical benefit in first randomised trial
pharmafile | April 24, 2020 | News story | Medical Communications, Research and Development | COVID-19, Gilead, coronavirus, pharma, remdesivir
Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.
In the China-based trial of 237 participants, 158 were randomised to receive remdesivir, while 79 received placebo plus standard of care. It was found that remdesivir failed to reduce the amount of the virus present in the bloodstream, and patients treated with it did not show clinical improvement.
“In this study of hospitalised adult patients with severe Covid-19, [which] was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the report on the WHO website read.
The trial was halted prematurely after 18 patients were forced to be taken off the medication due to significant side-effects compared to five with placebo, while 14% of the remdesivir group died, compared to 13% in the placebo group. There was no difference in recovery time between the two groups.
The findings of the trial were accidentally published by the World Health Organization before quickly being taken down.
“A draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is undergoing peer review and we are waiting for a final version before WHO comments,” explained WHO spokesperson Tarik Jasarevic.
The drug had previously shown benefit after it was provided to patients in multiple treatment scenarios on compassionate grounds, but critics warned that these studies were either anecdotal or did not feature adequate controls for conclusive judgements to be drawn.
Gilead however warned against premature and “inappropriate characterisations” of the study, commenting: “Importantly, because this study was terminated early due to low enrolment, it was underpowered to enable statistically meaningful conclusions. As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”
Matt Fellows
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