NIH Launches Trial Evaluating Hydroxychloroquine for COVID-19

The National Institutes of Health (NIH) has announced that a clinical trial evaluating hydroxychloroquine for patients with coronavirus disease 2019 (COVID-19) has launched. The trial will evaluate the safety and effectiveness of the agent in adults who are hospitalized with the novel virus.

The study is a blinded, placebo-controlled randomized clinical trials that will seek to enroll more than 500 adult patients. The participants will receive clinical care as indicated and individuals who are randomized to the experimental intervention will receive hydroxychloroquine.

In the hydroxychloroquine treatment group patients will receive hydroxychloroquine 400 mg twice daily for 2 doses on day 1 and then 200 mg twice daily for the subsequent 8 doses on days 2 to 5 or placebo twice daily for 5 days.

The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) study has started enrolling patients at the Vanderbilt University Medical Center in Nashville, Tennessee. The study is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH.

Hydroxychloroquine is just 1 agent that is being evaluated to treat COVID-19. The agent is used to treat malaria and rheumatoid conditions. In previous research, hydroxychloroquine has reportedly demonstrated antiviral activity, the ability to modify the activity of the immune system, and has an established safety profile at appropriate doses. However, the drug can cause dermatological reactions, seizures, cardiac arrythmias, and hypoglycemia.

“Many US hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness,” Wesley Self, MD, MPH, emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator leading the ORCHID trial, said in the announcement. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”