ST. LOUIS — Washington University researchers are leading a new trial testing the anti-malaria drug chloroquine on 30,000 front-line health care workers worldwide, to determine whether the drug can prevent COVID-19, or decrease its severity.
Scientists across the globe have responded to the urgent call for a vaccine and treatments for COVID-19, and mobilized clinical trials to study drugs like chloroquine.
“This is a new virus for humans,” said Michael Avidan, a professor of anesthesiology at Washington U. and one of the study’s principal investigators. “It swept across the globe — and we had nothing.”
The university is leading an international group of physicians and scientists designing a trial to study the drug’s effectiveness, and, if effective, to determine the lowest dose required. A lower dose would likely mean fewer side effects and would make it possible to treat more people with a limited supply of chloroquine.
“I don’t know whether or not chloroquine works,” Avidan said. “The way to figure that out is to do rigorous, scientific experiments.”
This is at least the second chloroquine trial for Washington U. Last month, the university announced it was launching a trial testing the drug on patients admitted to Barnes-Jewish Hospital for treatment of COVID-19.
The drug gained prominence in March after President Donald Trump recommended it as a treatment, despite concerns leveled by health officials across the world. They warned that chloroquine and derivative hydroxychloroquine were unproven against the coronavirus, and could be dangerous.
This week, Trump announced he was taking hydroxychloroquine.
Hydroxychloroquine and chloroquine have been used for decades, primarily to treat malaria and some inflammatory conditions. Avidan said this is a potential benefit, because developing a new drug could take years.
“We don’t have years,” Avidan said. “The notion of repurposing drugs is a very important one when you’re facing a situation like this.”
Avidan said researchers will probably have to identify the most effective combination of medications for treating COVID-19, but short of a vaccine, no one drug is likely to be a panacea.
Avidan said St. Louis-area health care workers can apply to participate in the trial.
Health care workers who have previously been infected with COVID-19, and those with underlying conditions that could make it unsafe to take chloroquine, like heart ailments, will not be eligible.
“We think that this is a potential benefit for St. Louis,” Avidan said. “I’ll be extremely thrilled and excited if many health care workers in our region take up the opportunity. … We want the health care workers in the St. Louis region in Missouri and southern Illinois to be well represented.”
The trial will largely be conducted remotely. Enrollment and consent will be done online.
Three groups of participants will receive various doses of chloroquine, and one will receive a placebo.
Participants will communicate twice a week through text messages and online data entry. They will take the tablets for three months, either daily, twice a week or weekly. They will be monitored for two months after.
The researchers will take blood samples at the beginning of the trial and at the end, to test for antibodies. If a participant shows symptoms of COVID-19, they will have a nasal swab taken to test for the virus.
The trial has an adaptive design, meaning the researchers could add or remove therapies if the initial data indicates that they are effective, or ineffective.
Rising Pharmaceuticals, headquartered in East Brunswick, New Jersey, is donating about 300,000 doses of chloroquine, for the trial’s U.S. participants.
The company has been ramping up production, and has added a manufacturing site, said Chief Operating Officer Ira Baeringer.