The blinded, placebo-controlled randomized clinical trial will seek to enroll more than 500 adult patients.
James Kiley, PhD
The article, “NIH Launches Trial Evaluating Hydroxychloroquine for COVID-19” was originally published on ContagionLive.
A clinical trial has launched to evaluate the safety and effectiveness of hydroxychloroquine for patients hospitalized with coronavirus disease 2019 (COVID-19), the National Institutes of Health (NIH) announced this week.
The study is a blinded, placebo-controlled randomized clinical trial 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 be randomly assigned to 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.
Effective therapies for COVID-19 are needed, James Kiley, PhD, director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute (NHLBI), said in a statement.
“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,” Kiley said. “However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”
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 NHLBI, part of the NIH.
There are not current therapies that have demonstrated effectiveness in preventing the prevention of COVID-19 to severe illness. There are medicines available in the US, however, that have been proposed as potential therapies.
Hydroxychloroquine is 1 agent that is being evaluated to treat COVID-19. The agent is used to treat malaria and rheumatoid conditions such as arthritis. 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.”
NIH also launched a trial to study Remdesivir to test the effectiveness and safety of the agent as a possible treatment for COVID-19. In the trial sponsored by the National Institute of Allergy and Infectious Diseases, investigators will test remdesivir versus placebo in an urgent race to find therapies proven effective for treating COVID-19.