Results from the long-awaited WHO Solidarity trial, which investigated the effects of remdesivir and three other potential treatment regimens in 11,266 hospitalized patients, found that none of the treatments “substantially affected mortality” or reduced the need for ventilating patients, according to a copy of the study seen by the Financial Times.
“These regimens of remdesivir, hydroxychloroquine, lopinavir and interferon appeared to have little effect on in-hospital mortality,” the study found.
The results of the WHO trial also showed that the drugs had little effect on how long patients stayed in hospital. However, WHO researchers said the study was primarily designed to assess the impact on in-hospital mortality. The study has not yet been peer reviewed.
Remdesivir was one of a series of drugs used to treat US President Donald Trump after he tested positive for Covid-19. It was developed by US drug maker Gilead Sciences, initially as a potential drug to treat Ebola.
Remdesivir received partial approval for use in the US and the EU after a trial by the US National Institutes of Health in April showed it reduced recovery time from Covid-19 from 15 days to 11 days. In July, Gilead released further data suggesting the treatment. may reduce the likelihood of death, but this finding has not been confirmed in a randomized controlled trial – the gold standard for drug approval.
“We are aware that the initial data from the World Health Organization (WHO) SOLIDARITY trial were made public before being published in a peer-reviewed journal,” Gilead said in response to a request. of comments. “The emerging data seem inconsistent with the stronger evidence from several randomized, controlled studies validating the clinical benefit of [remdesivir]. »
The WHO declined to comment, saying the study’s results were not yet public.
The WHO findings mean that the only drug that increases survival rates for Covid-19 is dexamethasone, a cheap steroid that can be taken orally and is widely available around the world. The WHO has recommended the use of steroids for patients with severe cases of Covid-19.
The Solidarity trial is one of the largest ongoing studies on Covid-19 treatments. Drugs can be added or removed from the trial at any time. The results for the four drugs in the study seen by the FT cover the period from March to early October.
The remdesivir arm of the trial involved 2,750 patients. Participants received the treatment for 10 days, with 200 mg given on the first day and 100 mg on the following days.
Andrew Hill, visiting principal researcher in the Department of Pharmacology at the University of Liverpool, said that a trial as large as Solidarity “should show survival benefit. [for the drug, if one existed]. »
Earlier this month, the EU signed an agreement with Gilead to deliver up to 500,000 treatment courses of the drug to European countries – including the UK – with an option to further increase orders.
Gilead priced remdesivir at $ 2,340 per five-day course. Some public health experts have said the cost is too high for a drug that has not been shown to reduce the likelihood of death.
The final analysis of the US NIH study of 1,062 patients, published last week in the New England Journal of Medicine, showed a decrease in hospital stays of about five days, from 15 to 10, but no significant mortality benefit for remdesivir.