PETAL Network: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among Inpatients With Symptomatic Disease (ORCHID) Trial

ORCHID was a multicenter, blinded, placebo-controlled randomized trial conducted at 34 hospitals in the US between April 2 and June 19, 2020. Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled, with the last outcome assessment on July 17, 2020. The planned sample size was 510 patients with five interim analyses; however, the trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients.The distribution of the day 14 clinical status score (measured using a 7-category ordinal scale) was not significantly different for patients randomized to receive hydroxychloroquine compared with placebo.Instructions for requesting individual-level data are available on BioData Catalyst at https://biodatacatalyst.nhlbi.nih.gov/resources/data/. Apply for data access in dbGaP. Upon approval, users may begin accessing requested data in BioData Catalyst. For questions about availability, you may contact the BioData Catalyst team at https://biodatacatalyst.nhlbi.nih.gov/contact.
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Inclusion: 1. Age ≥18 years.2. Currently hospitalized or in an emergency department with anticipated
hospitalization. 3. Symptoms of acute respiratory infection, defined as one or more of the following:
a. Coughb. Fever (> 37.5° C / 99.5° F)c. Shortness of breath (operationalized as any of the following:
subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy) d. Sore throat
4. Laboratory-confirmed SARS-CoV-2 infection within the past 10 days
prior to randomization Exclusion:1. Prisoner2. Pregnancy3. Breast feeding4. Unable to randomize within 10 days after onset of acute respiratory infection symptoms5. Unable to randomize within 48 hours after hospital arrival6. Seizure disorder7. Porphyria cutanea tarda8. QTc >500 ms on electrocardiogram within 72 hours prior to enrollment9. Diagnosis of Long QT syndrome10. Known allergy to hydroxychloroquine, chloroquine, or amodiaquine11. Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol12. Receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment13. Inability to receive enteral medications14. Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to Day 1515. Previous enrollment in this trial16. The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient]]>