'Hopeful' results in small remdesivir study published in New England Journal of Medicine

essentialsaltes said:

The group of patients received the anti-viral drug remdesivir as part of a “compassionate use'' trial, not a double-blind placebo-controlled trial which would offer more definitive evidence. Also, the cohort of patients was small, only 53 patients in the United States and around the world. Those limiting factors prevent scientists from declaring that the drug works.

Thirty six patients out of 53 — or two-thirds — showed improvement in oxygen support, trial authors said. Seventeen of 30 patients who were on ventilators were able to be taken off the life-support machines.

“We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Dr. Jonathan D. Grein, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.”

While 68 percent of the patients showed improvement in the level of oxygen support they needed, 13 percent died, the NEJM study said. That 13 percent compares favorably to mortality rates of 17 to 78 percent in China among severely ill patients, the authors wrote.

A senior scholar at the Center for Health Security at Johns Hopkins University’s Bloomberg School of Public Health, Amesh Adalja, called the results "encouraging'' while cautioning they needed to be kept in perspective.

"It’s unclear because it was not a controlled study whether they would have gotten better with or without it. That’s the problem that you have,'' he said.

NEJM link

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Yttrium said:

It makes a lot more sense than hydroxychloroquine, since remdesivir has apparently been effective on other types of coronavirus.

Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses

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essentialsaltes said:

The group of patients received the anti-viral drug remdesivir as part of a “compassionate use'' trial, not a double-blind placebo-controlled trial which would offer more definitive evidence. Also, the cohort of patients was small, only 53 patients in the United States and around the world. Those limiting factors prevent scientists from declaring that the drug works.

Thirty six patients out of 53 — or two-thirds — showed improvement in oxygen support, trial authors said. Seventeen of 30 patients who were on ventilators were able to be taken off the life-support machines.

“We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Dr. Jonathan D. Grein, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.”

While 68 percent of the patients showed improvement in the level of oxygen support they needed, 13 percent died, the NEJM study said. That 13 percent compares favorably to mortality rates of 17 to 78 percent in China among severely ill patients, the authors wrote.

A senior scholar at the Center for Health Security at Johns Hopkins University’s Bloomberg School of Public Health, Amesh Adalja, called the results "encouraging'' while cautioning they needed to be kept in perspective.

"It’s unclear because it was not a controlled study whether they would have gotten better with or without it. That’s the problem that you have,'' he said.

NEJM link

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sfs said:

Unfortunately, this is also really sketchy evidence for any effect. Real trials are underway for this drug, but this isn't one of them.

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There’s a new drug creating hope for treating the coronavirus, and unlike the president’s touting of hydroxychloroquine — which had a higher death rate in one study than in the control group that went without the anti-malarial — the new treatment, remdesivir, is backed up by an early clinical success. A study conducted by the National Institute of Allergy and Infectious Diseases found that patients on the drug were able to recover four days faster than those on a placebo, a decrease in recovery time of 31 percent.

“The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recovery,” NIAID head Dr. Anthony Fauci said at the White House on Wednesday. While the study, which featured more than 1,000 cases throughout the world, has not yet been subject to peer review, Fauci said its results were promising enough to create an “ethical obligation to immediately let the placebo group know so they can have access” to the drug, which was originally developed by Gilead Sciences to treat Ebola. On Wednesday, the New York Times reported that the Food and Drug Administration is expected to issue an emergency approval for remdesivir, while President Trump said during his coronavirus press conference that he wants the FDA to move “as quickly as they can.”

“This will be the standard of care,” Fauci said, adding that the trial has proved that “a drug can block this virus.” However, the NIAID study did not prove that remdesivir is a COVID-19 miracle drug: The mortality rate for those on the anti-malarial was 8 percent, compared to 11.6 percent for the placebo, which was described by NIAID as a statistically insignificant difference. On Wednesday, the medical journal The Lancet published results from a Chinese trial leaked last week by the World Health Organization with inconclusive results: Researchers found that the drug “did not significantly improve the time to clinical improvement, mortality, or time to clearance of virus in patients with serious COVID-19 compared with placebo.” However, the study was stopped early owing to the challenges of enrolling seriously ill patients as the outbreak eased up in China.

Gilead released its own study’s results on Wednesday, showing that sick patients on a five-day regimen of remdesivir did as well as patients on a ten-day regimen — though the biopharmaceutical company was criticized for an apparent attempt to “piggyback” on the NIAID study, according to Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes, who spoke to Politico. Bach added that Gilead’s claim that the results were successful even though there was no control in the trial had “no basis in scientific inquiry.”

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keith99 said:

Sadly real research does not come with the hype surrounding Trump approved medications.

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Ada Lovelace said:

Fauci Optimistic About 'Significant, Positive Effect of Coronavirus Treatment
In March the United States Army signed an arrangement with Gilead Sciences to provide remdesivir to troops confirmed to have the COVID-19 virus.
Btw. I'm Stanfordella with a new name and picture, so this is a followup to the above post.

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cow451 said:

Ada Lovelace? I once dated a stripper named Lovelace.

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Ada Lovelace said:

Fauci Optimistic About 'Significant, Positive Effect of Coronavirus Treatment

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sfs said:

But a study was also reported in the Lancet today showing no significant benefit from remdesivir. If the drug is effective, the effect doesn't seem to be very large. (Also, someone pointed out on Twitter that the primary endpoint of the study that Fauci reported changed during the course of the study, which is . . . unusual.) I'm hopeful that it's doing something, but it's not exactly knocking my socks off so far.

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Ada Lovelace said:

Ada Lovelace, the First Tech Visionary

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