Study Shows Remdesivir Is Ineffective At Reducing COVID-19 Mortality

Cornelia Mascio
Ottobre 18, 2020

There was no significant difference in mortality for hospitalized COVID-19 patients receiving the antiviral agent remdesivir (Veklury) compared to regular care, an interim analysis of a large World Health Organization (WHO) study found.

The WHO-funded study of four antiviral drugs, including Remdesivir and Hydroxychloroquine, involved more than 11,000 Covid-19 patients in 30 countries.

Health experts said the findings could come as a jolt to doctors across India who have been prescribing both remdesivir and hydroxychloroquine to Covid-19 patients under guidelines approved by the Union health ministry and the Indian Council of Medical Research (ICMR).

Remdesivir's maker, Gilead Sciences, said in a statement that the results are inconsistent with more rigorous studies and have not been fully reviewed or published.

The drug was granted emergency authorization by the Food and Drug Administration on May 1 following a trial by the National Institutes of Health, which found that remdesivir modestly reduced the time to recovery in severely ill patients.

"The results are unambiguous - there is no impact on mortality", K. Srinath Reddy, president of the New Delhi-based Public Health Foundation of India and member of an global group of researchers who monitored the trial, told The Telegraph.

Then, the authors looked at data on almost 740,000 COVID-19 patients and examined the use of drugs that work to protect these processes, asking whether patients who received them fared better - and they did, in some cases. Later that month it was approved for use in the United Kingdom, and has since been authorised for use in several other countries since.

"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 report said. These drugs also didn't seem to have any effect on reducing the need for a ventilator or in cutting short hospital stays, unlike the earlier remdesivir trial suggested. For interferon and remdesivir, the authors note, this trial accounts for more than three-quarters of all patients who have been randomised to receive them so far.

"When adding Solidarity to the trials we have to date, I think it is likely that a large mortality benefit does not exist, and in this context, the cost is too high", he said.

"Consequently, it is unclear if any conclusive findings can be drawn from the study results", the company said in a prepared statement.

Commenting on the findings, Dr. Soumya Swaminathan, WHO Chief Scientist, said, "Personal experiences are valuable".

He added that he hoped some questions about the trial would be resolved either in a revision to the preprint or when the results appear in a peer-reviewed journal. Almost 39 million people around the world have been diagnosed with COVID-19 and more than one million have died. We need scalable, affordable and equitable treatments.

Remdesivir has been touted as a potential therapy since the beginning of the pandemic and gained greater attention when it formed part of Donald Trump's cocktail of treatments.

"We're looking at monoclonal antibodies, we're looking at immunomodulators and some of the newer anti-viral drugs that have been developed in the last few months", she said.

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