Remdesivir, 3 other drugs have no effect on COVID-19 patients

Remdesivir has'little or no effect on Covid-19 mortality WHO study

Remdesivir has'little or no effect on Covid-19 mortality WHO study

The second worst-hit nation in coronavirus pandemic, India, that takes pride in the remarkable recovery rate, will reassess coronavirus treatment protocol after a large-scale trial conducted by World Health Organization (WHO) found that four commonly used re-purposed drugs had little impact in reducing mortality. "This is real world evidence". It received its emergency use authorization in August after promising results in trials.

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. More research is needed, the authors say, but for now, they conclude, they have "identified important molecular mechanisms and potential drug treatments that merit further ... study".

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

The drug costs $3,120 per treatment course for patients with private insurance in the United States.

The trial wasn't created to answer whether there may be a benefit for patients treated early after symptoms begin, as opposed to early after hospitalization. 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.

Until now, remdesivir has been the only drug that appeared to have specific effects for coronavirus.

"The main outcomes of mortality, initiation of ventilation and hospitalization duration were not clearly reduced by any study drug", according to the study.

The WHO trial was an open-label trial, in which 11,266 adults from 30 countries were randomized, with 2,750 allocated remdesivir, 954 hydroxychloroquine, 1,411 lopinavir, 651 interferon and lopinavir, 1,412 only interferon, and 4,088 no study drug. "The results increase our confidence that they are valid across large populations", he said.

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Dr. Soumya Swaminathan, WHO chief scientist, touted the Solidarity trial on Wednesday, calling it a "wonderful global collaboration" that benefited from preparations and investments made over the last few years, having learned from Ebola and other outbreaks.

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

The adaptive study initially had four arms - HIV drug Lopinavir/Ritonavir, anti-viral drug Remdesivir, anti-malarial drug Hydroxychloroquin and immunomodulator Interferon Beta-1a.

Remdesivir is the only antiviral drug that has been authorized for treatment of Covid-19 patients in the US.

Gilead received an initial, redacted manuscript in late September and still hasn't received the data necessary to validate Solidarity's results, a spokesman said in an email.

Differences in patients who participated in the trial at hundreds of clinical sites may undermine the quality of the data, said professor Peter Galle, who oversees infectiology at Germany's Mainz university hospital.

As scientific evidence emerged, the list was toned down to only Remdesivir and Interferon. Almost 39 million people around the world have been diagnosed with COVID-19 and more than one million have died.

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