The first subjects have been enrolled in a blinded, randomized, placebo-controlled trial to evaluate the efficacy of hydroxychloroquine (HCQ) in patients being admitted to the hospital for treatment of COVID-19. The ORCHID (Outcomes Related to COVID-19 treated with HCQ 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 Adaptive COVID-19 Treatment Trial (ACTT) is a similar blinded, randomized, placebo-controlled trial is underway to study remdesivir in the treatment of COVID-19. Subjects are being enrolled at the University of Nebraska Medical Center (UNMC) in Omaha. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.
“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said NIAID Director and U.S. Coronavirus Task Force member Anthony S. Fauci, M.D.
“A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
It will be at least several weeks before data is available from either study but this is the level of evidence we desperately need.