NIH Launches Clinical Trial of Hydroxychloroquine for COVID-19

April 10, 2020 - A clinical trial to evaluate the safety and efficacy of hydroxychloroquine for the treatment of hospitalized adult COVID-19 patients has begun, according to a recent press release from the National Institutes of Health (NIH).

NIH kicked off on Thursday the “Outcomes related to COVID-19 treated with hydroxychloroquine,” or ORCHID Study. The clinical trial will be conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of National Heart, Lung, and Blood Institute (NHLBI).

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

The first participants have enrolled in the trial at Vanderbilt University Medical Center in Nashville. It is one of the many centers in the PETAL Network. 

The blinded, placebo-controlled randomized clinical trial will enroll more than 500 adults who are hospitalized with COVID-19. Individuals will continue to receive clinical care as needed for their condition. 

Participants randomized to the experimental intervention will receive hydroxychloroquine 400 mg twice daily on one day, then 200 mg twice daily for the next eight doses, or a placebo twice daily for five days. 

There are currently over 395,000 cases of COVID-19 in the US and over 12,000 deaths. With cases continuing to increase each day, many organizations are working together to discover a drug or vaccine treatment for the virus. 

Some patients develop COVID-19 so severe that it progresses to acute respiratory distress syndrome and death. Although no therapies have been demonstrated to prevent the progression of COVID-19 to severe illness, many medicines have been deemed as potential treatments.

Recently, FDA approved issued an Emergency Use Authorization (EUA) for the emergency use of oral formulations of hydroxychloroquine for COVID-19 patients. 

The anti-malarial drugs showed promising success as a COVID-19 treatment. As part of the EUA, HHS accepted 30 million doses of hydroxychloroquine, donated by Sandoz, and chloroquine, donated by Bayer Pharmaceuticals, to distribute to hospitals across the country. 

An additional poll showed that hydroxychloroquine is the top three most commonly prescribed COVID-19 treatments, at 56 percent. And out of 15 options, physicians chose hydroxychloroquine as the overall most effective therapy for COVID-19. 

In various other studies, the drug demonstrated antiviral activity and the ability to modify the activity of the immune system. 

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

NIH also recently launched a clinical trial to study remdesivir, an anti-viral previously used to treat SARS and MERS. The trial will uncover the safety and efficacy of the drug in adults affected with COVID-19.

Remdesivir demonstrated in vitro and in vivo activity in animal models against MERS and SARS, which are similarly structured to coronavirus. Experts recently deemed remdesivir and hydroxychloroquine as two of the most promising COVID-19 treatments currently being tested. 

NIH urges anyone interested in learning more about the study to visit ClinicalTrials.gov and search identifier NCT04332991.