The antiviral drug remdesivir had no substantial impact on the survival of COVID-19 patients or the length of their hospital stays, according to a World Health Organization (WHO) clinical trial.
The results, announced late Thursday, could potentially be a major blow to the efforts of finding a suitable treatment to the disease that has killed more than 217,000 Americans.
The WHO Solidarity Trial examined the effects of four coronavirus different drug regimens: remdesivir; hydroxychloroquine; a combination of the anti-HIV drugs lopinavir and ritonavir; as well as interferon.
According to WHO, none of the drugs had any noticeable impact on reducing mortality, the duration of hospitalization, or the need to ventilate patients.
The study was billed as the world’s largest randomized control trial on COVID-19 therapeutics. It spanned 405 hospitals across 30 countries, and 11,266 adults. It has yet to be peer reviewed.
The results of the trial were first reported Thursday by the Financial Times.
WHO said other uses of the drugs, for example in treatment of patients in the community or for prevention, would have to be examined using different trials.
Remdesivir received emergency use authorization from the Food and Drug Administration on May 1 after it showed modest results in reducing the hospitalizations of patients with severe cases of COVID-19.
It has been authorized for use in more than 50 countries worldwide
Remdesivir was one of a number of medications given to President TrumpDonald John TrumpTwitter CEO calls blocking New York Post article without explanation ‘unacceptable’ Michael Cohen writing second book on Trump administration’s Justice Department As Trump downplayed the virus publicly, memo based on private briefings sparked stock sell-offs: NYT MORE when he was diagnosed with the disease earlier this month.
Manufacturer Gilead currently charges private insurers $3,120 per patient for a five-day course of the treatment.
Other developed countries and direct purchasers in the U.S. government, including the Veterans Affairs hospitals, will pay $2,340 for a five-day course of the drug.
The company has faced criticism from some lawmakers and drug pricing advocates for the high cost of a drug that seems to provide only a modest benefit.
However, Gilead Chairman and CEO Daniel O’Day said that the prices are below the actual value of the drug in order to provide “broad and equitable access.”
In a statement on Thursday, Gilead said it was aware the initial data had been made public “prior to publication in a peer-reviewed journal,” and noted limitations of the trial design.
The company said the findings of the WHO trial “appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals.”
A study sponsored by the National Institutes of Health and published in the New England Journal of Medicine earlier this month showed that hospitalized patients receiving remdesivir recovered five days faster on average, and in patients with severe disease, seven days faster, compared to a placebo.
The effect on mortality was not clear, and was not studied as part of the peer-reviewed, placebo-controlled…