The University of Washington School of Medicine is looking for people who have tested positive for COVID-19 to participate in a clinical trial aimed at finding out whether a controversial drug called hydroxychloroquine can keep them from having to be hospitalized.
Word of UW Medicine’s clinical trial comes after reports about a study at Veterans Health Administration medical centers in which COVID-19 patients who took hydroxychloroquine, which is typically used to treat malaria and autoimmune disease, died at higher rates than those who didn’t take the drug.
Today, the Food and Drug Administration warned that hydroxychloroquine carries “known risks” of potentially deadly heart complications — and said the drug should be used in supervised settings such as clinical trials, where the risks can be better studied and mitigated.
The Department of Veterans Affairs’ study involved patients who were being hospitalized for COVID-19. UW Medicine’s study, in contrast, will focus on patients who have tested positive for COVID-19 but aren’t sick enough to be in a hospital. The new study will be randomized, unlike the VA study, which should lead to more reliable results.
“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,” co-principal investigator Christine Johnston, an associate professor of medicine at UW, said today in a news release. “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.”
The trial will gauge the effectiveness of hydroxychloroquine as well as a combination of the drug with azithromycin, an antibiotic.
Two cohorts of outpatients will be enrolled in the trial, in high-risk and low-risk categories. Patients who are older than 60 or have underlying conditions such as diabetes, hypertension, obesity or lung problems are considered high-risk. Patients who are aged 18 through 59 without such conditions are considered low-risk.
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More than 600 patients in all will be enrolled at sites across the country, including UW as well as medical facilities in Boston, New Orleans, Chicago and Syracuse, N.Y.
The study will measure nasal viral shedding by asking study participants to collect daily nasal swabs for 14 days. Participants will also have their heart rhythm monitored to warn of any cardiac toxicity.
The viral shedding pattern will be compared between the different treatments. If a treatment leads to faster clearance of viral shedding, it could theoretically decrease the risk of passing the virus on to others.
If another medicine comes along that looks promising, the trial can test that as well, Johnston said.
The $5.8 million trial is funded by the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard, with support from an array of public and philanthropic donors.
Results from the trial are expected by July.
“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,” said co-principal investigator Jared Baeten, a professor of global health at UW.
The study is teaming with another hydroxychloroquine trial being led by UW Medicine in collaboration with New York University to determine whether the drug can prevent transmission in people exposed to the virus. That trial is also receiving funding from the COVID-19 Therapeutics Accelerator.
For more information about the clinical trial, including how to sign up, check out the COVID-19 Treatment Study home page.
