WHO's Solidarity trial shows repurposed drugs for Covid-19 are ineffective

Marco Green
October 17, 2020

Remdesivir does not improve COVID-19 survival odds, a large World Health Organization (WHO) trial of it and three other treatments has ruled.

The WHO's study, called the Solidarity trial, enrolled more than 11,300 adults with COVID-19 in 405 hospitals in 30 countries. The worldwide team of researchers has submitted its findings to a medical journal.

Earlier this month, data from a US study of remdesivir by Gilead showed the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo in a trial comprising 1,062 patients.

A lab technicians shows the coronavirus disease (COVID-19) treatment drug "Remdesivir" at Eva Pharma Facility in Cairo, Egypt June 25, 2020.

Syngene, the contract research subsidiary of Biocon, has a licensing agreement with Gilead to manufacture and distribute Remdesivir in 127 countries including India.

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.

"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.

Gilead appeared to challenge the findings. However, Gilead Sciences, which makes remdesivir, has begun to study the effect of an inhaled version of the drug.

In a statement, Gilead said it was "concerned" that the data from the trial had not undergone vigorous review, and that it was unclear whether any "conclusive findings" could be drawn from the results.

"We're looking at what's next".

"Remdesivir is an expensive medicine - it costs almost Rs 30,000 for a five-day course".

Asked for his opinion, Matthew Spinelli, MD, of University of California, San Francisco, cautioned that Solidarity involved many different settings around the world, with "heterogeneous approaches to the care of hospitalized COVID-19 patients", and thus trials done by the NIH may have more "external validity" to their guidelines. "Simple. Hydroxychloroquine did not work. It is time our policymakers and doctors and the national task force take off hydroxychloroquine for treating hospitalised Covid patients", Kalantri told this newspaper.

Why It's Important: There is no approved cure or vaccine to treat COVID-19 yet.

Dr. Andre Kalil, a principal investigator for the NIH trial at the University of Nebraska Medical Center in Omaha, said the Solidarity trial lacked some of the basics critical to scientific research: "No data monitoring, no placebo, no double-blinding, no diagnostic confirmation of infection". "The results increase our confidence that they are valid across large populations", he said.

"The outcome of in-hospital mortality is imperfect because deaths can of course occur outside of the hospital", Spinelli said, adding that remdesivir requires participants to remain in the hospital for the 10-day treatment.

A senior ICMR official declined to say what implications the findings would have on India's current treatment policy that prescribes both remdesivir and hydroxychloroquine. Later that month it was approved for use in the United Kingdom, and has since been authorised for use in several other countries since. The WHO had announced the inefficacy of hydroxychloroquine and lopinavir/ritonavir against Covid-19 earlier this year.

Other reports by Click Lancashire

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