UW Recruiting Coronavirus Patients For Hydroxychloroquine Trial

SEATTLE, WA — Researchers at the University of Washington School of Medicine are seeking current COVID-19 patients to participate in a clinical trial of two possible treatments for the illness.

Volunteers for the trial will be administered either hydroxychloroquine or hydroxychloroquine with azithromycin, an antibiotic. Some will receive a placebo.

Researchers hope the trial will provide a clear picture of both drugs' effectiveness since prior studies have failed to reach a consensus.

"Hydroxychloroquine has received considerable hype as a potential treatment for COVID-19 and has been confused with chloroquine, a drug stopped in a treatment trial in Brazil," the university said in a news release. "There is conflicting evidence on whether it works, which is why the research team at the University of Washington School of Medicine is conducting a rigorous trial to offer answers."

The Food and Drug Administration issued a safety warning on hydroxychloroquine and chloroquine on Friday, due to concerns the drugs can cause heart problems in some. The FDA said the drugs should only be used in supervised medical settings, like clinical trials, where risks can be mitigated.

Hydroxychloroquine is an antiviral medication that has been used to treat malaria and autoimmune diseases for decades, according to UW Medicine. Azithromycin has been used to treat bacterial infections but has not been shown to have antiviral activity in people.

While smaller studies have shown some positive results using the drug, UW researchers said none have proven a clear benefit.

"That's not nearly the kind of evidence that the public needs," said Jared Baten, professor of global health at UW. "This rigorous trial will quickly provide the answer [to] whether hydroxychloroquine with or without azithromycin is effective and safe, or whether we should move on to other potential therapies."

Researchers are looking for patients who recently tested positive for the new coronavirus but were not sick enough to be hospitalized. Enrollment groups will include patients considered low-risk — those under 60 and with no other medical conditions — and those classified at high-risk, including patients over 60 or with underlying conditions.

Learn more about the study or enroll here.

Unlike prior studies, which were conducted after patients developed lung infections, the UW trial concentrates on early treatment to prevent serious complications.

"We are recruiting patients with [a] recently diagnosed COVID infection and hope to show whether early treatment can keep them from having to be admitted to the hospital, said Christine Johnson, associate professor of medicine at UW. "We are studying whether the early treatment of COVID-19 prevents viral pneumonia and also seeing if the medications decrease viral shedding, which could have a potential benefit of reduced transmission of COVOID-19."

Participants in the study will provide daily nasal swabs over two weeks, which researchers will compare among the different treatments. Volunteers will receive a device to measure oxygen levels in their blood and asked to record their temperature. Another device will monitor heart rhythms for cardiac toxicity, which researchers said can be a serious side effect of the drug.

The university said the study can be adapted to incorporate other drugs if more potential treatments come to light.

The trial will include 630 patients across the United States, with sites planned in New York, Boston, Chicago, New Orleans and Syracuse. Researchers said results from the study are expected by July.

UW Medicine said the new study joins a separate trial being done in collaboration with NYU to determine if hydroxychloroquine can prevent transmission in people exposed to the virus. That trial includes 2,000 patients in six states who were close contacts with confirmed cases.

Find answers to frequently asked questions about hydroxychloroquine here.