SEATTLE — Researchers with the University of Washington School of Medicine are now enrolling outpatients with COVID-19 for a randomized controlled trial of the effectiveness of two drug regimens –hydroxychloroquine and hydroxychloroquine with azithromycin.
Dr. Christine Johnston is a researcher who will be studying the trial.
“I think it’s absolutely critical,” she says, “it’s the only way we can really understand whether the medications work.”
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.
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.
Another observational study conducted by the Veterans’ Health Administration raised concerns about the safety and efficacy of hydroxychloroquine in hospitalized patients with COVID-19. These patients were not treated in a randomized trial, raising concerns that sicker patients may have received the medication, and making the findings difficult to interpret.
“When patients go into the hospital, they’re already much sicker and have had infections for much longer. it may be much harder to treat with a medicine targeting a virus at that time,” Dr. Johnston said.
Friday, the FDA released a statement that chloroquine and hydroxychloroquine should be used in supervised settings, like clinical trials, where the potential risks can be better studied and mitigated.
“This has been very atypical in my experience, but it is urgent and that’s why we’re seeing this,” Dr. Johnston explains, “very few of these have actually been conducted in randomized clinical trials. What we’re seeing is some observational data that we wouldn’t take that as the definitive answer.”
In the UW School of Medicine trial, patients will have heart rhythm monitoring to ensure safety. The trial will also exclude people with underlying cardiac, kidney, or liver disease.
The UW School of Medicine trial will enroll 630 patients at sites across the country, including the University of Washington. Additional sites are planned in Boston, New Orleans, New York, Syracuse, and Chicago.
Researchers are seeking outpatients who were recently diagnosed with COVID-19 but are not sick enough to be in the hospital.
Results of the trial are expected by July. The findings will determine whether a treatment looks promising enough for larger clinical trials and whether the drugs are safe. The trial is adaptable so if another medicine comes along that looks promising, the trial can test that as well.