The National Institutes of Health (NIH) halted a clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Interestingly, with absolutely no harm reported, the associated data and safety monitoring board (DSMB) met last Friday and determined that the study drug was “very unlikely to be beneficial to hospitalized patients with COVID-19.” The DSMB recommended to the National Heart, Lung and Blood Institute (NHLBI), part of the NIH, to stop the study.
Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis. In various studies, the drug had demonstrated antiviral activity, an ability to modify the activity of the immune system, and it has an established safety profile at appropriate doses, leading to the hypothesis that it may have also been useful in the treatment of COVID-19.
As TrialSite News shared recently, Dr. Davey Smith, a leading anti-viral expert, shared with a local news source in San Diego that unfortunately due to a confluence of forces and factors—including a series of “mixed messages”—the NIH as well as the U.S. Food and Drug Administration (FDA) removed the drug from the emergency use authorization list.
UCSD’s Dr. Smith suggested hydroxychloroquine’s use with antibiotic azithromycin was thought to be most useful in the earliest stages of the COVID-19 infection. However, because of mixed messages, the drug was used in later state COVID-19 cases and, ultimately, it was “untenable” to keep certain trials going.
The PETAL Network
The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, was being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of NHLBI.
The ORCHID Study was a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel were blinded to study group assignment.
The first participants enrolled in the trial in April at Vanderbilt University Medical Center, Nashville, Tennessee, one of dozens of centers in the PETAL Network. The blinded, placebo-controlled randomized clinical trial aimed to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. More than 470 were enrolled at the time of study’s closure.
The data from this study indicate that this drug provided no additional benefit compared to placebo control for the treatment of COVID-19 in hospitalized patients.
All participants in the study received clinical care as indicated for their condition. Those randomized to the experimental intervention had also received hydroxychloroquine. Participants in the study will now continue to receive standard of care and follow up as indicated for their condition.
Boyd Taylor Thompson, MD, Massachusetts General Hospital
Call to Action: Interested in learning more? Consider contacting James P. Kiley, PhD, Director, Division of Lung Diseases, who is available for interviews.