NIH Clinical Trial of Hydroxychloroquine for COVID-19 Begins

April 14, 2020

The NIH announced a clinical trial to evaluate hydroxychloroquine safety and efficacy in patients hospitalized with COVID-19.

The first participants have been enrolled in a clinical trial to evaluate the safety and efficacy of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19), according to a news release from the National Institutes of Health (NIH).

The ORCHID (Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease) 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.

The blinded, placebo-controlled randomized clinical trial will enroll >500 adults currently hospitalized with COVID-19 or in an emergency department awaiting hospitalization.

Participants will be randomly assigned to receive hydroxychloroquine 400 mg twice daily for 2 doses (day 1), then 200 mg twice daily for the subsequent 8 doses (days 2 to 5) or a placebo twice daily for 5 days. All participants will receive ongoing clinical care as indicated for their condition.

“Effective therapies for COVID-19 are urgently needed,” said James P. Kiley, director, Division of Lung Diseases, NHLBI in the NIH release. “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.”

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“Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2...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.

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The course of COVID-19

COVID-19 typically presents as an acute infectious respiratory illness but has been associated with damage to multiple organ systems, including heart, lung, and blood. And while approximately 80% of infected adults experience cough, fever, and fatigue that resolve within 1 to 3 weeks, severe disease affects some, manifesting as pneumonia and respiratory failure, progressing to acute respiratory distress syndrome and death.

FDA-approved indications for hydroxychloroquine include malaria and rheumatoid conditions. The hypothesis that the drug may be useful treatment for COVID-19 is based on its observed antiviral and immune-modifying activity. The drug has an established safety profile at appropriate doses, but is not without risks, including cardiac arrythmias, seizures, dermatological reactions, and hypoglycemia, after even short term use.

“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,” said Wesley Self, MD, MPH, emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator leading the ORCHID trial in the news release.  “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

The first participants have enrolled in the trial at Vanderbilt University Medical Center, Nashville, a PETAL Network center. More information about the study is available at ClinicalTrials.gov using the search identifier NCT04332991.

For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.

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