Covid: Remdesivir 'has little or no effect' on survival, says WHO

Remdesivir has little effect on COVID-19 mortality, study says

In a study it described as both conclusive and disappointing, the World Health Organization said the antiviral drug remdesivir has "little or no effect on mortality" for patients hospitalized with coronavirus and it doesn't seem to help patients recover any faster, either.

A cocktail of treatments given to President Trump after he tested positive for the coronavirus included remdesivir.

"These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay", the researchers wrote in a preprint on the findings of the WHO's Solidarity trial that was released on medRxiv.

SOLIDARITY's findings are particularly grim news for the U.S., where remdesivir is one of just two treatments to have gotten emergency Food and Drug Administration (FDA) authorization.

Of the 11,266 adults who were randomised in 405 hospitals across 30 countries, 2,743 people were given Remdesivir and 2,708 were part of control group or usual care.

Gilead, which got the Solidarity data 10 days ago, questioned the findings, telling Reuters they appear "inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir".

The drug's manufacturer Gilead rejected the findings of the trial.

It didn't look into other uses of the drugs for COVID-19, like in treating patients in a COVID-19-infected community, or for COVID-19 prevention. According to a report by Reuters, data from a USA study of remdesivir lead by Gilead showed the use of the treatment cut COVID-19 recovery time by five days in a trial comprising 1,062 patients. About 1,000 patients took part in that trial. However, the other trials continued.

"We are concerned that the data from this open label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design", Gilead added. Supplies of the drug have been limited, and the European Medicines Agency is now reviewing whether remdesivir is causing kidney problems as reported by some patients. Almost 39 million people around the world have been diagnosed with COVID-19 and more than one million have died.

Andrew Hill, a senior visiting research fellow at the University of Liverpool's department of pharmacology, said a trial as large as Solidarity "would be expected to show a survival benefit [for the drug, if one existed]".

WHO's Solidarity trial will continue to evaluate other treatments, including newer antiviral drugs, immunomodulators, and anti-SARS COV-2 monoclonal antibodies, the United Nations agency said.

Meanwhile in China researchers say a vaccine under development has been found to be safe and to trigger immune responses in combined early and mid-stage trials.

"We're looking at what's next". However, WHO researchers said the study was primarily created to assess the impact on in-hospital mortality.



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