University of Washington researchers are among the leaders of a newly announced clinical trial investigating whether hydroxychloroquine, a drug that’s commonly used to counter malaria and autoimmune disease, can prevent COVID-19.
The multi-site trial, managed by UW in collaboration with New York University’s Grossman School of Medicine, aims to determine definitively whether taking the drug can prevent transmission in people exposed to the virus.
“We currently don’t know if hydroxychloroquine works, but we will learn in as short a timeframe as possible what the outcome is,” principal investigator Ruanne Barnabas, associate professor of global health in the University of Washington Schools of Medicine and Public Health, said today in a news release.
The trial is due to run for eight weeks, with results expected by this summer.
Small-scale studies have led to suggestions that hydroxychloroquine sulfate and a related drug, chloroquine phosphate, might help head off coronavirus infections — but so far, the results are mixed. The promise of protection from coronavirus was touted several times by President Donald Trump, causing concern about its availability for its traditional purposes. The drugs also have potentially life-threatening side effects if used improperly.
UW physicians are already using hydroxychloroquine to treat patients who have been diagnosed with COVID-19, but outside the setting of a clinical trial.
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On Sunday, the Food and Drug Administration officially authorized the emergency use of both hydroxychloroquine and chloroquine for use against COVID-19. To boost supplies for hospital treatments and clinical trials, the Department of Health and Human Services accepted donations of 30 million doses of hydroxychloroquine from Sandoz, a division of Novartis, and 1 million doses of chloroquine from Bayer Pharmaceuticals.
The UW-NYU team is starting to enroll 2,000 participants who are close contacts of persons with confirmed or pending COVID-19 diagnoses. Participants must live in Western Washington or New York, and must be referred by health care providers.
Those who enroll in the study will be randomly assigned to take hydroxychloroquine or a placebo over two weeks, and nasal swab samples will be collected and tested daily to confirm new COVID-19 infections across the two groups. All participants in the trial will be screened carefully to make sure they aren’t allergic to the medication, and they’ll be monitored at home through telehealth consultations.
“Currently, there is no proven way to prevent COVID-19 after being exposed,” said Anna Bershteyn, assistant professor of population health at NYU and co-principal investigator on the study. “If hydroxychloroquine provides protection, then it could be an essential tool for fighting this pandemic. If it doesn’t, then people should avoid unnecessary risks from taking the drug.”
The $9.5 million clinical trial is one of three studies receiving grants from the COVID-19 Therapeutics Accelerator, a $125 million initiative launched by the Bill & Melinda Gates Foundation, Wellcome Trust, and Mastercard to speed the development and distribution of therapies for COVID-19.