0705 GMT June 22, 2021
The drug, made by the US biotech firm Gilead, has been talked up as a potential cure and was taken by Donald Trump. A trial in the US had previously showed it reduced the length of stay in hospital. But the gold-standard Solidarity WHO trial, which was based on a far larger sample — 3,000 people on the drug, compared with as many who were not — showed remdesivir had little effect on deaths over 28 days, theguardian.com reported.
Gilead was told about the results on September 23, 10 days before publication, and was given a first draft of the study on September 28. The WHO said the company was told the outcome in advance as part of an agreement to provide the drug for free.
On October 8, Gilead signed a contract for 500,000 doses of the drug with the European commission — which did not know the results — at a cost of €850 million (£733 million).
The agreement to disclose the results to the company before publication was made at the beginning of the trial, said Dr. Soumya Swaminathan, chief scientist at the WHO. “It is an agreement in good faith,” she said, adding that it allowed Gilead to check whether any errors had been made, but did not allow the company to change the analysis or conclusions.
Many countries have already put remdesivir on their treatment list for COVID-19 patients, based on the much smaller US study that found the drug shortened hospital stays.
The WHO’s guideline committee will look at the data from its trial and others and decide what recommendations to make about the drug.
Three other drugs were trialed in the Solidarity study, which has recruited more than 12,000 patients across 30 countries, and none had very much effect on mortality. They were hydroxychloroquine, which had already been found to have no benefit by the University of Oxford’s Recovery trial, lopinavir, an antiretroviral used in HIV treatment, and interferon, given as an injection under the skin.
“Interferon was disappointing,” said Oxford’s Professor Sir Richard Peto, who was the chief statistician in the trial. “This regime didn’t do much for survival.”
However, it is still possible that interferon given in other ways or in different formulations may have an effect.
The remdesivir results constitute the bulk of the evidence for the drugs being used, Peto said. “It is more than three times as big as all the other evidence in the world put together.”
The Solidarity trial had to be taken seriously, he continued. “The quality of this trial is excellent. This is real world evidence. The phrase has been hijacked by people — a lot of wrong answers have come out from people trying to play games by avoiding randomization.
With remdesivir, there were 300 deaths among people randomly assigned to the drug and 300 among others not on the drug. “It doesn’t guarantee there is exactly no effect, but it does very much constrain what it is possible to claim,” he said.
Martin Landray, a professor of medicine and epidemiology at Oxford and one of the leads on the Recovery trial, said the results of the Solidarity trial were important but sobering.
“Four different drugs were studied in over 11,000 patients at 405 hospitals in 30 countries. The trial is beautiful in its simplicity and clarity of purpose — large, randomized and focused on the ultimate clinical outcome of survival. None of the four treatments studied — hydroxychloroquine, lopinavir, interferon, remdesivir — showed worthwhile benefits.”