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 growing evidence that the drug frequently promoted by President Donald Trump doesn’t seem to work against the novel coronavirus.
Nearly 800 people from 38 states participated in the trial, which was funded with $9.5 million from the COVID-19 Therapeutics Accelerator, a research fund created by The Bill & Melinda Gates Foundation, the British philanthropy Wellcome, and others.
The volunteers who participated in the clinical trial all had a family member or close contact who had tested positive for the infection. Participants were randomly assigned to get either a daily pill of hydroxychloroquine or placebo over a 14-day period. The volunteers swabbed their noses every day and sent the specimens to a lab for analysis to see if they became infected.
Among the group receiving hydroxychloroquine, 46 people became infected with the novel coronavirus. In the placebo group, the total number of infections was 43. The difference wasn’t statistically significant, indicating the drug had no effect, said Dr. Ruanne Barnabas, the 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 became 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 acquisition of (the novel coronavirus) or treatment of COVID-19,” Barnabas said.
Previous studies have found the drug, originally used to treat malaria, also has no benefit for patients hospitalized with COVID-19 or people with mild infections who took the drug early in the course of the disease. It also did not prevent infection when taken prophylactically by health care workers and other first responders.
Both the World Health Organization and the U.S. National Institutes of Health suspended clinical trials on the drug because there is no evidence it is effective. The UW study adds to that evidence, which some researchers say is already overwhelming.
“This is yet another trial that confirms the lack of efficacy of hydroxychloroquine,” Eric Topol, director of the Scripps Research Translational Institute said in an email. “It’s helpful because there was some residual uncertainty about the potential for very early use, and this trial confirms no utility there as well. Simply put, hydroxychloroquine has NO role in preventing or treating covid-19.”
But a few other clinical trials are still underway, including one 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 could be particularly useful in the developing world.
“One of the motivations for doing this study is because hydroxychloroquine is safe and widely available and it would be fantastic to have an affordable, safe, easily accessible, scalable intervention,” Barnabas said.
But discussions of the drug became highly politicized, creating controversy that impacted the research. After early reports of possible cardiac side effects, enrollment in the clinical trials plummeted. Slow recruitment delayed the UW trial, which Barnabas had initially hoped would be wrapped up by summer.
One large study that claimed to have data from hundreds of hospitals showing higher levels of heart arrhythmias and death rates in patients who received hydroxychloroquine was later retracted, adding to the mistrust and turmoil.
The UW results were presented Saturday at IDWeek 2020, the annual scientific meeting of the Infectious Disease Society of America. The complete study will be published in the journal Open Forum Infectious Diseases.
