The drug is in short supply worldwide due to the excitement it has generated. It is one of the drugs that Donald Trump has declared “promising”.
In a “gold standard” trial of 237 patients, some of whom received remdesivir while others did not, the drug did not work. The trial was also halted early due to side effects.
The news of the failure was published in a World Health Organization clinical trial database, but subsequently deleted. A WHO spokesperson said it was downloaded too early by accident.
“A draft document was provided by the authors to WHO and inadvertently published on the website and withdrawn as soon as the error was discovered. The manuscript is under peer review and we are awaiting a final version before comments from WHO, “said Tarik Jasarevic, WHO spokesperson.
The drug, manufactured by the American company Gilead Sciences, is an antiviral which has been tested on Ebola, but which has not shown any benefits in Africa.
In the race for drugs that could work against Covid-19, many doctors have given patients “remessivir” for “compassionate reasons” without waiting for trials. Because of his interest, the world’s largest trial of possible treatments for Covid-19 at Oxford could not include it because the researchers were unable to obtain supplies.
Testing the drug in China on patients with severe symptoms of Covid-19 may give some doctors a break. Gilead, however, said there were still signs that it might be helpful, perhaps in patients with milder versions of the disease.
In the trial, 158 patients were randomly assigned to receive remdesivir, while another 79 received standard care with a placebo instead. There was no difference in the groups as to the speed of patient recovery. Slightly less than 14% of people on remdesivir died, compared to almost 13% of those who did not follow treatment.
“In this study of adult patients hospitalized with severe Covid-19, [which] was discontinued prematurely, remdesivir was not associated with clinical or virological benefits, “said the report on the WHO website.
The report adds: “Remdesivir was stopped early in 18 (11.6%) patients due to adverse events, compared to 4 (5.1%) in the control group.” The short report did not contain any details on the side effects that led to the termination of the trial.
Just over a week ago, it appeared that Chicago researchers were delighted with the results of a Gilead study of 125 patients using remdesivir. Almost all of these people were released within a week, according to STAT News, which tracks the pharmaceutical industry. However, there was no placebo group, which means the researchers cannot be sure that the drug made the difference and nothing else.
Remdesivir is one of a handful of drugs that have been enthusiastically endorsed by doctors and politicians as potential remedies for Covid-19. There has also been a rush to deliver patients with hydroxychloroquine, a less toxic version of the antimalarial chloroquine. This has resulted in shortages for people who have to take it for lupus, a disease that affects the immune system.
Scientists who want to see proper trials conducted are likely to point to the failure of the remdesivir trial as solid proof of the dangers of distributing even tested drugs for compassionate reasons about such a new disease.