ST. LOUIS — Washington University School of Medicine announced Thursday that it is launching a clinical trial to investigate the controversial drug chloroquine to treat the new coronavirus.
The drug gained prominence last month 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 can be dangerous. Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, cautioned that the evidence in favor of the drugs was largely anecdotal.
But the pressure to quickly mobilize research around the new coronavirus is immense. Scientists around the world have dropped other work to join the search for treatments and vaccines. St. Louis University recently announced that it would take part in a study of remdesivir, a drug previously tested on the Ebola virus.
The Washington U. trial is one of 20 concurrent chloroquine studies around the world, researchers said. It came together rapidly, said infectious disease specialist Dr. Rachel Presti, an associate professor of medicine and co-lead of the trial.
“This study went from conception to first patient enrolled in 13 days,” Presti said. “That’s just unheard of.”
Presti said the trial is critical: Some believe that the drugs work to reduce the coronavirus’ impacts.
“We really don’t know that,” she said.
That uncertainty is part of the reason these trials are so important, she said. All three drugs involved in the trial have side effects.
“There are situations where giving a drug is worse than just supporting people,” Presti said.
The Washington U. trial will look at different combinations of chloroquine, hydroxychloroquine and the antibiotic azithromycin. Hydroxychloroquine and chloroquine have been used to treat malaria and some inflammatory conditions. Azithromycin is an antibiotic used to treat infections caused by bacteria, including respiratory, skin, ear and eye infections.
The goal is to determine if any of the medications decrease the severity or duration of respiratory symptoms associated with the new coronavirus.
There will be four groups of patients in the trial. One will receive chloroquine, a second will receive hydroxychloroquine, a third will receive chloroquine and azithromycin, and the fourth will receive hydroxychloroquine and azithromycin.
Dr. Jane O’Halloran, an assistant professor of medicine at Washington University and co-lead of the trial, said other studies compare the drugs to a placebo, to determine if using the medications is better than not using them.
The Washington U. study has no placebo group, and instead looks at whether there is an ideal combination of the drugs.
O’Halloran said that multiple concurrent studies is an unusual tactic for researchers to take. Usually, the studies would follow each other, building off the previous research.
“It is a little bit unusual that these questions are being answered in tandem rather than sequentially, which we would probably normally do,” O’Halloran said. “We’re trying to maximize the amount of information we can get in a shorter period of time.”
The patients will be treated with the drugs over the course of five days. Then, for the remainder of the six-week period, the researchers will continue monitoring their condition.
Express Scripts has donated the medications to the school.
Patients hospitalized with confirmed cases of COVID-19 at Barnes-Jewish Hospital will be enrolled, and other sites may be added later.
As of Thursday, there were only about 10 patients enrolled. Researchers hope to get 500 eventually, though they say social distancing could slow the rate of new infections — which, in turn, would affect the availability of patients to participate in the trial.
O’Halloran hopes researchers will see less severe illness and faster recovery for COVID-19 patients treated with these drugs, but ultimately the pandemic will be resolved by the public health measures that can prevent people from becoming infected in the first place.
“There is no wonder drug, for any disease,” O’Halloran said.
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