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ORCHID: Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease

April 2020 to June 2020
NCT Identifier: 

Effective therapies for COVID-19 are urgently needed. The PETAL Network is responding to the COVID-19 crisis and redirecting effort to develop and deploy COVID-19 trials. The first was the ORCHID Trial. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19. Preliminary reports suggested potential efficacy in small human studies. Clinical trial data was needed to determine whether hydroxychloroquine is effective in treating COVID-19.

ORCHID was a blinded, multicenter, placebo-controlled randomized clinical trial of oral doses of Hydroxychloroquine as compared to a matching placebo to treat patients hospitalized with COVID-19 illness (by positive test or presumed positive based on protocol specific criteria).

This trial was launched in the first week of April and enrolled 479 patients in less than 3 months. It was stopped mid-June after showing no evidence of benefit or harm.

UPDATE JUNE 20, 2020

Major US Trial Closes Showing No Benefit for Hydroxychloroquine in COVID-19

June 20, 2020

The Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease (ORCHID) trial stopped enrolling new patients based on the fourth scheduled interim analysis showing no evidence of benefit or harm.

The ORCHID trial enrolled 479 adult patients hospitalized with COVID-19 in 11 weeks at 34 hospitals in the United States. It was a multicenter, blinded, placebo-controlled randomized trial, which is the most rigorous study design to evaluate the effects of a medication. In addition to usual medical care for COVID-19, patients in the trial were treated with either 5 days of hydroxychloroquine or a placebo pill that did not have medication in it. Patients, treating clinicians, and researchers were all “blinded,” meaning that they did not know whether a given patient was receiving hydroxychloroquine or placebo.

Preliminary results suggested that hydroxychloroquine was neither beneficial nor harmful for patients with COVID-19. A full analysis of trial results is ongoing and will be submitted for peer review as soon as possible.

“We rapidly conducted a high-quality study to understand if hydroxychloroquine helps patients hospitalized with COVID-19,” said Wesley H. Self, MD, an emergency physician at Vanderbilt University Medical Center and lead investigator for ORCHID. “These results provide a high level of certainty that hydroxychloroquine is not a useful treatment for adults admitted to the hospital with COVID-19.”

Samuel M. Brown, MD, a critical care physician at Intermountain Medical Center who helped lead the trial said, “It was critically important to understand the effects of hydroxychloroquine when used to treat COVID-19. We express our sincere gratitude to the patients, families, and research staff who participated in this important study.”

The ORCHID trial was funded by the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health (NIH), and conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network, a group of researchers at approximately fifty hospitals focused on answering important questions for patients with severe illness evaluated in an emergency department or hospital.