NIH Begins Clinical Trial of Hydroxychloroquine for COVID-19

April 13, 2020

A clinical trial evaluating the safety and efficacy of hydroxychloroquine in hospitalized patients with COVID-19 has begun.

Hydroxychloroquine, an experimental therapy for coronavirus disease 2019 (COVID-19), is being investigated in a clinical trial led by the National Institutes of Health (NIH), according to the agency. The trial, which will evaluate the drug’s safety and efficacy in patients hospitalized with COVID-19, has begun with its first participants now enrolled in Tennessee.

Although preliminary reports have implicated hydroxychloroquine’s use in treating patients with COVID-19, clinical trial data is needed to determine its safety and efficacy in this setting.

The trial, called the Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) study, enrolled its first participants at Vanderbilt University Medical Center. The study will include more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization.

Hydroxychloroquine is indicated for the treatment of malaria and rheumatoid conditions such as arthritis, but is not approved for the treatment of COVID-19. However, previous studies have shown the antiviral activity of the drug. Although hydroxychloroquine has an established safety profile at appropriate doses, short-term use can be associated with the risk of cardiac arrythmias, seizures, dermatological reactions, and hypoglycemia.  

Patients in the study will be randomly assigned to receive hydroxychloroquine 400 mg twice daily  for 2 doses, then 200 mg twice daily for the subsequent 8 doses or a placebo twice daily for 5 days.

“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 a statement. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

>In March, the FDA granted Emergency Use Authorization (EUA) to hydroxychloroquine sulfate and chloroquine sulfate for emergency use in hospitalized patients with COVID-19, the agency’s first EUA for a therapeutic product. According to the FDA fact sheet for health care workers, optimal dosing and duration of treatment for hydroxychloroquine is not known, but suggested parameters will be updated as more clinical data surfaces. However, the FDA recommends 800 mg on the first day of treatment, and then 400 mg daily for 4 to 7 subsequent days.

 

References:

 

1. NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins. News Release. NIH; April 9, 2020. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-hydroxychloroquine-potential-therapy-covid-19-begins. Accessed April 13, 2020.