Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network - Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID)
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April 2020 – July 2020
December 21, 2020
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused widespread cases of coronavirus disease 2019 (COVID-19), many of which have resulted in hospitalization or death. Hydroxychloroquine has been considered as a potential therapy for COVID-19 due to its anti-inflammatory effects and in vitro studies suggesting antiviral activity. However clinical trials were recommended to evaluate efficacy and safety in treatment of patients with COVID-19.
Adults who were hospitalized for less than 48 hours with laboratory-confirmed SARS-CoV-2 infection and symptoms of respiratory illness for less than 10 days were enrolled. The trial was initially designed to also include patients with suspected infection, but the trial shifted to only include laboratory-confirmed cases after testing capacity increased. The main exclusion criteria were more than 1 dose of hydroxychloroquine or chloroquine in the prior 10 days; QTc interval greater than 500 ms; prior receipt or planned administration of select medications that prolong the QTc interval; and seizure disorder. 1,878 patients completed screening, 1,041 were found eligible, 242 were randomized to the hydroxychloroquine treatment arm, and 237 were randomized to the placebo treatment arm.
ORCHID was a multicenter, blinded, randomized clinical trial comparing hydroxychloroquine vs placebo among hospitalized adults with respiratory illness from COVID-19. Patients were enrolled between April 2, 2020, and June 19, 2020, at 34 hospitals in the PETAL network. Eligible participants were randomized in a double-blind fashion to hydroxychloroquine or placebo in a 1:1 ratio, stratified by enrolling hospital.
The first dose of the trial drug was administered within 4 hours of randomization. Patients assigned to the hydroxychloroquine group received 400 mg of hydroxychloroquine sulfate in pill form twice a day for the first 2 doses and then 200 mg in pill form twice a day for the subsequent 8 doses, for a total of 10 doses over 5 days. Patients assigned to the placebo group received matching placebo in the same dosing frequency. Patients discharged from the hospital before day 5 continued the trial medication after discharge to complete the 10-dose course. As part of safety assessment, trial personnel systematically assessed the QTc interval between 24 and 48 hours after administration of the first dose of trial drug. Additional doses of the trial drug were held for a QTc greater than 500 ms.
The primary outcome was clinical status 14 days after randomization, assessed with a 7-category ordinal scale (the COVID Outcomes Scale) recommended by the World Health Organization. Patients who were discharged from the hospital were contacted by telephone for assessment of the COVID Outcome Scale at 7, 14, and 28 days after randomization.
Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults.
Self WH, Semler MW, Leither LM, et al. Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2020;324(21):2165-2176. doi:10.1001/jama.2020.22240
This dataset is also available on BioData Catalyst. Learn more here: https://biodatacatalyst.nhlbi.nih.gov/covid-19/.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 625.9 KB)
- ORCHID Protocol (PDF - 1.2 MB)
- ORCHID SOPs (PDF - 1.8 MB)
- ORCHID Statistical Analysis Plan (PDF - 849.9 KB)
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