In a multinational trial by the World Health Organisation, the antiviral drug Remdesivir had little or no effect on mortality rate or the length of hospital stay among COVID-19 patients.
The study was part of the WHO’s ‘Solidarity’ trial investigating four drug regimens including remdesivir, hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon in more than 11,000 patients across 30 countries.
The study found the regimens appeared to have little or no effect on 28-day mortality or the length of the in-hospital course among patients hospitalized with COVID-19, the WHO said, according to a Reuters report.
The study results were uploaded on the preprint server medRxiv and are yet to be peer-reviewed.
Remdesivir, an experimental anti-viral drug that was initially developed by ‘Gilead Sciences’ to work against Ebola, has been at the centre of discourse on potential COVID-19 treatments.
The drug has already been given to thousands of hospitalised COVID-19 patients, including the United States President Donald Trump.
In the US, remdesivir was issued an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to treat severe patients in hospital settings in early May, which was later extended to all hospitalised patients regardless of disease severity.
Remdesivir had also been granted authorization for 'restricted emergency use' in India to treat severe COVID-19 patients. India's drug regulator granted US pharma giant Gilead Science marketing authorisation via an accelerated process.
A recent study on the drug by Gilead on over 1,000 patients had shown that it reduced COVID-19 recovery time by five days compared to those who got a placebo.
The company told Reuters, "The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir.”
"We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design."
The WHO study authors noted, “For each of these foud repurposed non-specific antivirals, several thousand patients have now been randomized in various trials.”
“The unpromising overall findings from the regimens tested suffice to refute early hopes, based on smaller or non-randomized studies, that any will substantially reduce inpatient mortality, initiation of ventilation or hospitalisation duration. Narrower confidence intervals would be helpful (particularly for Remdesivir), but the main need is for better treatments.”
While multiple trials on the drug are still underway, the evidence so far has been divided on its efficacy, as FIT had earlier reported. Doctors have been warning not to look at it as a ‘miracle cure’ or a ‘knock-out’ drug just yet, as more studies raise questions over its benefit.
(The article was first published in FIT and has been republished with permission.)
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