Researchers at the University of Washington on Friday announced a major new study of the malaria drug President Donald Trump has praised as a possible, low-cost cure for COVID-19.
The clinical trial is one of dozens around the world aimed at providing definitive evidence about the effectiveness of hydroxychloroquine, either alone or in combination with the antibiotic azithromycin, against the novel coronavirus.
The 60-year-old drug has become the focus of intense attention and debate — both scientific and political — since Trump first began enthusing about its potential in White House briefings. Evidence at the time was scant, limited to a few test-tube studies and anecdotal reports from France.
“There is a lot of excitement about hydroxychloroquine, and a lot of chatter,” said Dr. Christine Johnston, an infectious-diseases specialist at the UW School of Medicine and co-leader of clinical trials that will be conducted at several universities and medical centers across the country.
Small-scale trials and observational studies over the past two months have done little to clear up the picture, with some finding modest benefits, others finding none and some suggesting the drug could cause dangerous heart problems.
A preliminary analysis of 368 patients at Veterans Health Administration hospitals hinted at higher death rates among those who got the drug, but the study was not randomized and it’s possible doctors preferentially gave the drug to their sickest patients.
Citing the risk of abnormal heart rhythms, the Food and Drug Administration on Friday warned doctors not to prescribe hydroxychloroquine or an older version called chloroquine, with or without azithromycin, for COVID-19 — except in hospitals or as part of a clinical trial where patients can be closely monitored.
“We don’t know if these medicines are effective and we need to know,” Johnston said. “But we also need to make sure they’re safe, and in a clinical trial we can achieve both those things.”
Earlier studies in China that found little benefit focused on extremely ill patients, but the UW project will study people with confirmed coronavirus infections who are not sick enough to be hospitalized. The goal is to find out if early treatment could protect people from developing viral pneumonia. The researchers also want to see if people who get the drug show reduced viral shedding, which might mean they are less likely to pass the disease on to others.
The team hopes to enroll 630 patients nationwide, including 100 to 150 in the Seattle area. Participants will be randomly assigned to receive either a 10-day course of hydroxychloroquine, hydroxychloroquine plus azithromycin or a placebo. Results should be available by July.
Johnston and her team are collaborating with another national hydroxychloroquine trial coordinated by the UW. Led by epidemiologist Dr. Ruanne Barnabas, that project is trying to find out if the drug might prevent infection in people who have been exposed to the virus.
Both trials are funded by the COVID-19 Therapeutics Accelerator, a $200 million fund seeded and established by the Bill & Melinda Gates Foundation, the British philanthropy Wellcome and many other donors. Johnston’s project got $5.8 million, Barnabas’ got $9.5 million.
Both projects are also pioneering an approach that doesn’t require participants to leave their homes. Initial interviews will be conducted via telemedicine applications and those who qualify will get drugs and nasal swabs to detect viral shedding delivered to their homes.
They will also receive fingertip pulse oximeters, thermometers and compact heart monitors to check their own vital signs and detect possible heart complications, pneumonia or more serious problems that might require hospitalization.
People with underlying heart, kidney or liver disease will be excluded from the study. But older people and those with diabetes, high blood pressure and lung problems that put them at high risk from the novel coronavirus can enroll, along with younger, healthier people.
Other researchers and physicians at Seattle-area hospitals are conducting controlled trials to see if hydroxychloroquine in various doses and combinations will help their critically ill patients.
“There has been a proliferation of studies because everyone really wants to know the answer,” Johnston said. She shifted her own research focus from herpes viruses to the novel coronavirus out of a sense of urgency.
“We’re all just trying to use whatever skills we have to combat this pandemic and contribute in any way we can.”
More information about the treatment trial is available at www.covid19treatmentstudy.org. Information about the trial to see if hydroxychloroquine can prevent coronavirus infection is available at www.covid19pepstudy.org.