The world’s largest randomized trial of COVID-19 treatments found “conclusive evidence” that remdesivir, a drug used to treat U.S. President Donald Trump when he fell ill, has little or no effect on severe cases, the U.N. health agency said Friday.
The World Health Organization announced the long-awaited results of a six-month trial that endeavored to see if existing drugs might have an effect on the coronavirus.
The study, which was not peer-reviewed, found that four treatments tested — remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon — had “ little or no effect” on whether or not patients died within about a month or whether hospitalized patients recovered.
Most of those had already been ruled out. But remdesivir, an antiviral, has been classified as standard-of-care in the United States, and it has been approved for use against COVID-19 in the UK and EU. Supplies of the drug have been limited, and the European Medicines Agency is now reviewing whether remdesivir is causing kidney problems as reported by some patients.
The results of the global trial are in sharp contrast to a large study in the United States, which found remdesivir shortened the time to recovery by about five days on average.
Martin Landray, a professor of medicine and epidemiology at Oxford University, said the WHO trial results for hydroxychloroquine and lopinavir were in line with a previous British study he co-led.
“The big story is the finding that remdesivir produces no meaningful impact on survival,” he said in a statement. He said the drug is now recommended in some countries but there have been significant concerns about supply, cost and access.
“This is a drug that has to be given by intravenous infusion for five to 10 days,” noting it costs about $2,550 per treatment course. “COVID affects millions of people and their families around the world. We need scalable, affordable, and equitable treatments.”
The treatments given to President Trump after he tested positive for the coronavirus included remdesivir.
Science Mag adds:
One of the world’s biggest trials of COVID-19 therapies released its long-awaited interim results yesterday—and they’re a letdown. None of the four treatments in the Solidarity trial, which enrolled more than 11,000 patients in 400 hospitals around the globe, increased survival—not even the much-touted antiviral drug remdesivir. Scientists at the World Health Organization (WHO) released the data as a preprint on medRxiv last night ahead of its planned publication in the New England Journal of Medicine.
Yet scientists praised the unprecedented study itself and the fact that it helped bring clarity about four existing, ‘repurposed’ treatments that each held some promise against COVID-19. “It’s disappointing that none of the four have come out and shown a difference in mortality, but it does show why you need big trials,” says Jeremy Farrar, director of the Wellcome Trust. “We would love to have a drug that works, but it’s better to know if a drug works or not than not to know and continue to use it,” says WHO’s chief scientist, Soumya Swaminathan.
The prospects of two of the four treatments—the malaria drug hydroxychloroquine and the HIV drug combination ritonavir/lopinavir—had faded after another large study, the United Kingdom’s Recovery trial, showed them not to increase survival in June. After analyzing that study and its own data up till then, WHO decided to drop both from the study.
There was still hope for remdesivir and for interferon-beta, which initially had been given in combination with ritonavir/lopinavir but was tested as a standalone drug after the Recovery data came out. But neither of those treatments lowered mortality or delayed the moment patients needed ventilation to help them breathe. The results in these two treatment arms are likely to be the most scrutinized.
Remdesivir, which attacks a specific enzyme in several RNA viruses and was previously tested against Ebola, was initially seen as a promising candidate. In a U.S. trial with more than 1000 COVID-19 patients published last week, those who received remdesivir had a shorter recovery time than patients in the control group, but there was no significant difference in mortality. Two smaller trials found few significant benefits. Remdesivir received an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) in May for severe COVID-19 patients that was later expanded to include all patients.