Results expected soon on the experimental trial of a coronavirus drug

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The results of a long-awaited study on an experimental coronavirus treatment for the sickest patients are expected every day.

Doctors leading the clinical trial of the drug, called remdesivir, say the rapidly evolving pandemic has forced them to work in a hurry, without compromising the scientific rigor needed to prove whether the drug really works.

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“We are in a race against the clock,” Dr. Andre Kalil, principal investigator for the trial at the University of Nebraska Medical Center, told NBC News. “We are doing everything we can 24/7 to make this happen. “

Previous research has hinted at the promise of remdesivir, an antiviral drug that would work by preventing the virus from replicating in the body. But these studies were either based on animal data or had major caveats, such as the absence of a control group.

A study published earlier this month in the New England Journal of Medicine found that the drug improved breathing in some patients, but the study was small, with only 53 patients. And its authors did not compare the results of their patients with a control group of patients to know for sure whether the improvements were really due to remdesivir, or whether they would have improved by themselves, without treatment.

The ongoing clinical trial at the University of Nebraska Medical Center, in partnership with dozens of other sites around the world, includes a control group.

The essay is sponsored by the National Institutes of Health. Gilead Sciences, who developed the drug, is also involved.

“This is something we need to do as perfectly as possible,” said Kalil. “You must have reliable data. It is the soul of all study. “

Researchers should also carefully consider any side effects that may be associated with the drug. Mild to moderate abnormalities in liver function have been noted previously.

Beyond remdesivir

If remdesivir proves safe and effective against the coronavirus, Kalil said the trial will focus on studying other drugs. Investigators would use remdesivir as a control and see how well other drugs compare.

A treatment on the bridge is called baricitinib, an anti-inflammatory drug used to treat rheumatoid arthritis.

“There is hope that this drug can reduce inflammation and help prevent the spread of the virus from one cell to another,” said Kalil.

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Medication that can reduce inflammation may be essential. The immune system naturally sends inflammatory chemicals to the site of an injury or infection to try to fight it. But sometimes the immune system overreacts and pulls too much, damaging otherwise healthy tissue.

Researchers are trying to find the ideal point for such an inflammation – enough to stimulate the immune system to fight the virus, but without doing too much.

Clinical trials for other treatments of COVID-19, the disease resulting from the new coronavirus, have also started.

Pharmacist Alexion Pharmaceuticals has started studies on Soliris (eculizumab), which is an immunosuppressant. And Roche is studying his arthritis medication, called Actemra (tocilizumab).

Another attention-grabbing drug, hydroxychloroquine, is used to treat malaria. Trials of the drug are underway, but the drug has so far shown no significant benefit in early studies.

Indeed, the COVID-19 treatment guidelines recently published by a group of experts within the National Institutes of Health refused to recommend any treatment – including remdesivir and hydroxychloroquine – for routine use because the scientific data are not yet available.

“There are currently no drugs that have been proven to be safe and effective in treating COVID-19. There is insufficient data to recommend for or against the use of any antiviral or immunomodulatory therapy in patients with COVID-19 who have mild, moderate, severe or critical illness, “wrote the panel online.

Evidence that treatment works for COVID-19 would be a game-changer, said Dr. Michael Saag, associate dean for global health at the University of Alabama in Birmingham. Saag was not involved in any of the treatment trials.

“Once we know it, we could then mass produce it and make it available to everyone who starts showing symptoms, and get it to them as soon as possible,” he said.

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