Remdesivir useless in covid fight

Andrew Cummings
October 18, 2020

The results of a large treatment trial for hospitalized covid-19 patients funded by the World Health Organisation offer little good news.

Remdesivir, developed for Ebola by US pharmaceutical company Gilead Sciences, was one of the earliest treatments put forward for COVID-19 and was taken by US President Donald Trump when he was admitted to hospital with the disease at the beginning of the month.

For its Solidarity clinical trial, the World Health Organization tested the effects four potential treatments - remdesivir, an Ebola drug, was one, but they also looked at malaria drug hydroxychloroquine, auto-immune drug interferon, and the HIV drug combination of lopinavir and ritonavir. The participants were given four drugs singly or in combination: remdesivir, hydroxychloroquine, lopinavir, interferon or interferon plus lopinavir.

The WHO findings conflict with data published earlier this month by Gilead. "The interim analysis showed no benefits of remdesivir in any groups of COVID-19 (asymptomatic/mild/moderate/severe/critical) patients", ICMR said in a statement on October 16.

The UN agency hired independent statistician and epidemiologist Richard Peto to evaluate its "Solidarity Therapeutics Trial" results after USA biopharmaceutical company Gilead criticized the WHO's methodology, saying the trial's findings appeared inconsistent with evidence from other studies.

Hydroxychloroquine's off-label use for moderately-ill coronavirus patients was approved by India's drug regulator, while remdesivir was approved for "emergency use authorization". Later that month it was approved for use in the United Kingdom, and has since been authorised for use in several other countries since.

In the end, no drug or combination reduced mortality, the chances that mechanical ventilation would be needed or time spent in the hospital, compared with the patients without drug treatment.

The SOLIDARITY trial is the largest randomised, controlled study of its kind.

Gilead questioned the findings, saying that Solidarity "prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results".

The trial recorded 301 deaths among 2,743 patients who received remdesivir and 303 deaths among 2,708 control patients who had received best standard care.

"The big story is the finding that remdesivir produces no meaningful impact on survival", Martin Landray, an Oxford University professor who led other coronavirus treatment research, said in a statement. The National Institutes of Health also includes seven doctors paid by the drug's producer on its coronavirus panel.

"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 [hospitalization] duration".

"The real disappointment is that remdesivir has also failed in a larger number of cases and in the "real world setting", Clemens Wendtner, Chief Physician of Infectiology and Tropical Medicine at Munich's Schwabing Clinic, said.

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

The study plans to conduct a trial on novel antiviral drugs, immunomodulators and anti-SARS COV-2 monoclonal antibodies.

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