A large clinical trial conducted 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 promoted by President Donald Trump early in the pandemic doesn't seem to work against the novel coronavirus.
Nearly 800 people from 38 states volunteered for 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 goal was to find out whether hydroxychloroquine could protect people who had been exposed to the virus from getting infected and sick. Participants all had a family member or close contact who had tested positive for the virus, and 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.
Among the group receiving hydroxychloroquine, 46 people became infected with the novel coronavirus. There were 43 infections in the placebo group. The difference wasn't statistically significant, indicating the drug had no protective effect, said Dr. Ruanne Barnabas, the UW Medicine physician and researcher who led the project.
The study also found no evidence that people who got hydroxychloroquine were less likely to develop symptoms when 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 randomized controlled trials have found that the drug, originally used to treat malaria, didn't reduce death rates or odds of needing mechanical ventilation in patients hospitalized with COVID-19. Nor did it provide any benefit for people with mild infections who took the drug early in the course of the disease. Hydroxychloroquine also did not prevent infection when taken prophylactically by health care workers and other first responders before they were exposed to the virus.
Both the World Health Organization and the U.S. National Institutes of Health suspended clinical trials on the drug because of the mounting evidence against its usefulness.
The UW study is just the latest to confirm that the drug does not help patients, Dr. 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," he wrote. "Simply put, hydroxychloroquine has NO role in preventing or treating COVID-19."
A few other clinical trials are still underway, including one by a group of researchers in Detroit also funded by The Gates Foundation.
The Seattle philanthropy had hoped the drug might prove to be an inexpensive, effective 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.
Trump's early advocacy, based on questionable studies and laboratory tests that showed the drug could kill the virus in cell cultures, turned hydroxychloroquine into a political flashpoint and spawned controversy that spilled over to the research.
After reports of possible cardiac side effects, enrollment in the clinical trials plummeted. One large study that claimed to have data from hundreds of hospitals showing higher levels of heart arrhythmias and death in patients who received hydroxychloroquine was later retracted, adding to the mistrust and turmoil.
Slow recruitment delayed the UW trial, which Barnabas had initially hoped to wrap up by summer.
Dr. Jason Goldman, an infectious disease specialist at Swedish Medical Center, gave the drug to some of his hospitalized COVID-19 patients early in the pandemic when physicians were scrambling for any way to help sick and dying people.
"The president was tweeting and speaking to the press telling everyone to use it, and we had a bunch of well-meaning clinicians — me being one of them — who looked at the available evidence and thought: Well, hydroxychloroquine might work, based on what we're seeing in cell culture," Goldman said.
By spring, observations from hospitalized patients and data from small treatment trials were already suggesting the drug was not saving lives or keeping people from getting sicker.
"After early May, I never prescribed it," Goldman said. "There was nothing to support it."
There's still only one drug — the antiviral remdesivir — approved by the FDA to treat COVID-19.
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.
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