The malaria and arthritis drug much-touted by President Donald Trump, hydroxychloroquine, is getting its chance under the microscope now, with the beginning of a clinical trial by the National Institutes of Health to determine its potential as a COVID-19 therapy.
Testers hope the drug could have potential with adults hospitalized by the pandemic. The trial’s first participants are being pulled from Tennessee, to be enrolled at the Vanderbilt University Medical Center in Nashville, Tennessee. For the more than 500 adults expected to be enrolled, the test will be blind, placebo-controlled and randomized. It will be run by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network.
“Effective therapies for COVID-19 are urgently needed,” James Kiley, director of the Division of Lung Diseases at the National Heart, Lung and Blood Institute, said. “Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”
The drug has the potential for severe side effects, even in its designated role for treating malaria and rheumatoid conditions. Even short use can lead to cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia. Yet, in various studies, it has also shown antiviral potential, the capability to modify immune system activity and what the NIH labels an established safety profile at appropriate doses.
“Many U.S. hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness,” Dr. Wesley Self, emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator leading the ORCHID trial, said. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
All participants in the study will continue to receive clinical care. ORCHID participants will be randomly assigned 400 mg of hydroxychloroquine twice per day for two doses on the first day, then 200 mg twice daily for the subsequent eight doses for up through day five, followed by a placebo twice daily for five days after.
Those hardest hit by COVID-19 see it manifest as an acute respiratory infectious illness, capable of damaging multiple organ systems. Fever, coughing, fatigue, pneumonia and respiratory failure have all been associated with the disease, which has infected more than 1,619,000 people worldwide and killed more than 97,000, according to Johns Hopkins University as of Friday.
Currently, no approved therapies for COVID-19 exist.