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A large clinical trial coordinated by the University of Washington found that people who took hydroxychloroquine were just as likely to get Covid-19 as those who took a placebo, adding to mounting evidence that the drug frequently promoted by the United States President Donald Trump does not appear to work against the new coronavirus.
Nearly 800 people from 38 US states participated in the trial, which was funded by $ 9.5 million (NZ $ 14 million) from the Covid-19 Therapeutics Accelerator, a research fund created by The Bill & Melinda Gates Foundation. , British philanthropy Wellcome and others.
All of the volunteers who participated in the clinical trial had a family member or close contact who had tested positive for the infection.
Participants were randomly assigned to receive either a daily hydroxychloroquine pill or a placebo for a period of 14 days. The volunteers cleaned their noses every day and sent the samples to a laboratory for analysis to see if they had become infected.
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Among the group that received hydroxychloroquine, 46 people became infected with the new coronavirus. In the placebo group, the total number of infections was 43. The difference was not statistically significant, indicating that the drug had no effect, said Dr. Ruanne Barnabas, a UW Medicine physician and researcher who led the project. .
The study also found no evidence that hydroxychloroquine reduced the level of symptoms in people who were infected.
“I think this finding is consistent with the other randomized controlled trials … that hydroxychloroquine, based on the strong evidence we have to date, does not have a clinically significant impact on the acquisition (of the novel coronavirus) or the treatment of Covid – 19, ”Barnabas said.
Previous studies have found that the drug, which was originally used to treat malaria, also has no benefit for hospitalized Covid-19 patients or people with mild infections who took the drug early in the course of the disease. Nor did it prevent infection when taken prophylactically by health workers and other first responders.
Both the World Health Organization and the US National Institutes of Health suspended clinical trials on the drug because there is no evidence that it is effective. The University of Washington study adds to that evidence, which some researchers say is already overwhelming.
“This is another trial that confirms the lack of efficacy of hydroxychloroquine,” Eric Topol, director of the Scripps Translational Research Institute, said in an email. “It’s useful because there was some residual uncertainty about the possibility of very early use, and this test doesn’t confirm any utility there either. Simply put, hydroxychloroquine has NO role in preventing or treating Covid-19. “
But a few other clinical trials are still underway, including one conducted by a group of researchers in Detroit.
The Gates Foundation has funded multiple hydroxychloroquine studies, in hopes of finding an inexpensive treatment for Covid-19 that may be particularly useful in the developing world.
“One of the motivations for doing this study is that hydroxychloroquine is safe and widely available and it would be great to have a scalable, affordable, safe and easily accessible intervention,” said Barnabas.
But discussions about the drug became highly politicized, creating a controversy that impacted the investigation. After the first reports of possible cardiac side effects, enrollment in clinical trials plummeted. The slow recruitment delayed the University of Washington trial, which Barnabas had initially expected to conclude in the summer.
A large study that claimed to have data from hundreds of hospitals showing higher levels of cardiac arrhythmias and death rates in patients receiving hydroxychloroquine was later withdrawn, adding to the mistrust and confusion.
The UW results were presented Saturday at IDWeek 2020, the annual scientific meeting of the Infectious Disease Society of America. The full study will be published in the Open Forum Infectious Diseases journal.
– The Seattle Times