Researchers from the University of Washington Schools of Public Health and Medicine have received $5.8 million from the COVID-19 Therapeutics Accelerator initiative to conduct a multi-site randomized controlled trial to determine the effectiveness of two drug regimens – hydroxychloroquine with and without azithromycin – for patients with coronavirus disease 2019 (COVID-19).
The COVID-19 Therapeutics Accelerator is funded by the Bll & Melinda Gates Foundation, Wellcome and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling-up treatments.
The trial, co-led by Jared Baeten, vice dean for the UW School of Public Health, and Christine Johnston, associate professor of medicine in the Division of Allergy and Infectious Diseases at the UW School of Medicine, is enrolling participants who have tested positive for COVID-19 from sites across the country, including Seattle, Boston, New Orleans, New York, Syracuse and Chicago.
Hydroxychloroquine, the antiviral medication used to prevent malaria and treat autoimmune diseases, has seen its fair share of attention as a potential treatment for COVID-19. Azithromycin is used to treat a wide variety of bacterial infections, but it has not been shown to have antiviral activity in people.
Small studies have shown encouraging results using hydroxychloroquine but also no benefit, said Baeten, also a professor of global health, epidemiology and medicine and the Schools of Public Health and Medicine.
"That’s not nearly the kind of evidence that the public needs," he said about small studies. "This rigorous trial will quickly provide the answer whether hydroxychloroquine with or without azithromycin is effective and safe, or whether we should move on to other potential therapies.”
The trial will enroll outpatients by telehealth who have tested positive for COVID-19 but are not sick enough to be in a hospital. In all, 630 participants will be enrolled into one of two cohorts – high-risk or low-risk. High-risk outpatients are those over age 60 or with any underlying risk factors, such as diabetes, hypertension, obesity or lung problems. The low-risk cohort are outpatients age 18 to 59 without any of those conditions. Volunteers in the trial are enrolled into three arms: hydroxychloroquine, hydroxychloroquine with the antibiotic azithromycin or a placebo.
“We are recruiting patients with recently diagnosed COVID infection and hope to show whether early treatment can keep them from having to be admitted to the hospital,” said Johnston, a co-principal investigator of the study. “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 COVID-19."
Potential treatments such as hydoxychloroquine should be used in supervised settings, like clinical trials, according to a statement released on April 24 by the U.S. Food and Drug Administration. This is to help ensure that the potential risks can be better studied and mitigated. In this trial, patients will have heart rhythm monitoring to ensure safety. The trial will also exclude people with underlying cardiac, kidney or liver disease.
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.