Another clinical trial testing hydroxychloroquine in hospitalized patients with COVID-19 has been stopped, this one by the US National Institutes of Health (NIH). The agency said that the ORCHID study’s data and safety monitoring board found, after having conducted its fourth interim analysis, that while hydroxychloroquine was not associated with any harm, it was “very unlikely to be beneficial” in this patient population.
The first participants were recruited in April, with more than 470 having been enrolled at the time of the study’s closure. ORCHID was aiming to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. The trial was being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the NIH’s National Heart, Lung, and Blood Institute.
Patients were randomly assigned to receive hydroxychloroquine 400 mg twice daily on the first day, then 200 mg twice daily for days two to five, or a placebo twice daily for five days. All participants in the study received clinical care as indicated for their condition.
In explaining its decision to test the antimalarial in the first place, the NIH noted that “various studies…had demonstrated antiviral activity, an ability to modify the activity of the immune system, and [hydroxychloroquine] 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.”
Latest study closure
In the last few weeks, hydroxychloroquine testing for COVID-19 has been halted in the World Health Organization’s ongoing global Solidarity Trial, the University of Oxford’s RECOVERY trial, and most recently, in a Phase III study being run by Novartis.
The NIH decision to end the trial also comes after the FDA revoked emergency use of chloroquine and hydroxychloroquine last week, saying the drugs “may not be effective to treat COVID-19.”