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The massive WHO remdesivir study suggests no benefit to Covid-19. Doctors are not so sure.



A large, global study of potential drugs to treat Covid-19 suggests remdesivir – one of the few drugs available for the virus – could offer no real benefit to sick patients . But doctors at the front line of treatment of serious cases advise caution when interpreting the findings.

“We already know that in the more sick population, it has not really changed the outcomes,” said Dr. Ken Lyn-Kew, a pulmonologist in the critical care section at National Jewish Health in Denver.

That does not mean that remdesivir – which was approved for emergency use by the Food and Drug Administration in May ̵

1; is not beneficial against Covid-19.

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The new study – which includes data from more than 11,200 people in 30 countries – is the result of a World Health Organization Solidarity test. It was published online on Thursday on the preprint server medRxiv, meaning it has not been reviewed by a peer.

Remdesivir is not the only treatment given to patients on trial. Some have received hydroxychloroquine (which has since been shown to be ineffective in treating Covid-19), lopinavir (an antiviral used to treat HIV) and interferon (another antiviral). Some have received a combination of medications. Others only got one. Others did not receive treatment.

The trial found that in general, remdesivir did not reduce mortality and did not help patients with severe Covid-19 get out of the hospital quickly.

The latest discovery contradicts a large trial funded by the National Institutes of Health drug, which found that remdesivir reduced the amount of time it takes for adults hospitalized in Covid-19 to be released from at the hospital.

Dr. Andre Kalil, a chief investigator for the NIH trial at the University of Nebraska Medical Center in Omaha, said the Solidarity trial lacked some of the basics critical of scientific research: “No data tracking, no placebo, no double blindness, not diagnostic confirmation of infection. “

“Poor quality study design cannot be fixed by a large sample size, no matter how large it is,” Kalil told NBC News.

Outside experts also said it is not surprising that the drug did not appear to benefit the most painful patients. Remdesivir is an antiviral drug. Like Tamiflu for the flu, antiviruses are generally more effective when given early in the course of the illness.

“We know that in a more diseased population, it has not really changed outcomes,” Lyn-Kew said. “This study only confirms that this is not a miracle drug.”

A potential barrier to early treatment with remdesivir is that it is administered intravenously. It cannot be prescribed in pill form for newly diagnosed patients to be taken home. However, Gilead Science, which produces remdesivir, began to study the effects of a inhaled version of the drug. If safe and effective, it can be used at home, before the process of inflammation of the body.

That inflammatory process, rather than severe viral infection, is responsible for the more serious consequences of Covid-19. In theory, once inflammation is acquired, an antiviral drug to reduce the amount of virus in the body would be less effective, at best.

“It makes sense to expect an antiviral to have a reducing effect,” said Cameron Wolfe, an infectious disease specialist and an associate professor of medicine at Duke University School of Medicine. People infected with Covid-19 generally go through an initial stage of infectivity that can be affected by an antiviral.

“The second stage is more hyper-inflammatory,” Wolfe said. “It’s probably not surprising that if you’re in the middle of a newly inflamed second stage, an antiviral drug has fewer side effects.”

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Wolfe also expressed frustration that the WHO released the findings as a prelude, contrary to a peer-reviewed study.

A preprint “could be OK in January or February when we actually had an emergency health emergency and wanted to disseminate critical information quickly,” he said, adding, “We are moving into a space now where it is changing. the standard of care by statement is a really dangerous example. “

“The highest quality data we publish anywhere still says that remdesivir is effective,” Wolfe said.

“I’ll hang my hat on that data every time.”

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