A study evaluating the safety and effectiveness of hydroxychloroquine for the treatment of patients with coronavirus disease 2019 (COVID-19) has been initiated by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute, part of the National Institutes of Health (NIH).
The ORCHID (Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease) study is a blinded, placebo-controlled randomized clinical trial that is expected to enroll 500 patients currently hospitalized with COVID-19 or those in the emergency department who will likely be hospitalized; the first participants have been enrolled at Vanderbilt University Medical Center in Tennessee. In addition to supportive care, patients in the intervention arm will receive hydroxychloroquine (oral or enteral dose of 400mg twice daily on the day of enrollment, then 200mg twice daily for the next 4 days for a 5 day total course).
Treatment outcomes will be measured using a 7-category ordinal scale called the COVID Ordinal Outcomes Scale, at day 15. The 7 categories include death; hospitalized on invasive mechanical ventilation or ECMO (extracorporeal membrane oxygenation); hospitalized on non-invasive ventilation or high flow nasal cannula; hospitalized on supplemental oxygen; hospitalized not on supplemental oxygen; not hospitalized with limitation in activity (continued symptoms); and not hospitalized without limitation in activity (no symptoms).
Currently, there are no approved treatments for COVID-19, however, several investigational therapies are in the works. “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. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
Hydroxychloroquine is approved by the Food and Drug Administration for the treatment of malaria, lupus, and rheumatoid arthritis. The treatment, however, is not without risks. Recently, the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) published a joint statement cautioning clinicians about the potential cardiovascular complications associated with the drug.