Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among Inpatients With Symptomatic Disease - ORCHID
Contribution To Literature:
The ORCHID trial failed to show that hydroxychloroquine was superior to placebo at improving outcomes in hospitalized COVID-19 patients.
Description:
The goal of the trial was to evaluate hydroxychloroquine compared with placebo among patients hospitalized with coronavirus disease 2019 (COVID-19).
Study Design
- Randomized
- Parallel
- Blinded
- Placebo
Patients hospitalized with COVID-19 infection were randomized to hydroxychloroquine 400 mg twice daily for two doses, then 200 mg twice daily for eight doses (n = 242) versus placebo (n = 237).
- Total number of enrollees: 479
- Duration of follow-up: 28 days
- Mean patient age: 57 years
- Percentage female: 44%
- Percentage with diabetes: 36%
Inclusion criteria:
- Patients ≥18 years hospitalized <48 hours with laboratory-confirmed COVID-19 infection
- Symptoms of respiratory illness <10 days
Exclusion criteria:
- >1 dose of hydroxychloroquine or chloroquine within the last 10 days
- QTc interval >500 ms
- Prior use or planned use of medications that prolong the QTc interval
- Seizure disorder
Other salient features/characteristics:
- Receiving extracorporeal membrane oxygenation (ECMO) or invasive ventilation, 5.4%
- Receiving noninvasive ventilation or nasal high-flow oxygen, 11.6%
- Receiving supplemental oxygen without positive pressure or high flow, 47.9%
- Not receiving supplemental oxygen, 35.1%
Principal Findings:
The primary outcome of clinical status at 14 days assessed with a 7-category ordinal scale was 6 in the hydroxychloroquine group compared with 6 in the placebo group (p = nonsignificant).
Secondary outcomes:
- All-cause death at 28 days: 10.4% of the hydroxychloroquine group compared with 10.6% of the placebo group (p = nonsignificant)
- Median time to recovery: 5 days in the hydroxychloroquine group compared with 6 days in the placebo group (p = nonsignificant)
Interpretation:
Among patients hospitalized with COVID-19 infection, hydroxychloroquine was not beneficial. Hydroxychloroquine compared with placebo did not improve clinical outcomes, time to discharge, or survival. Hydroxychloroquine is not recommended for the treatment of patients hospitalized with COVID-19 infection.
References:
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;Nov 9:[Epub ahead of print].
Editorial: Saag MS. Misguided Use of Hydroxychloroquine for COVID-19: The Infusion of Politics Into Science. JAMA 2020;Nov 9:[Epub ahead of print].
Clinical Topics: COVID-19 Hub, Prevention, Novel Agents, Statins
Keywords: Chloroquine, Coronavirus, Coronavirus Infections, COVID-19, Extracorporeal Membrane Oxygenation, Hydroxychloroquine, Noninvasive Ventilation, Patient Admission, Patient Discharge, Primary Prevention, Respiration, severe acute respiratory syndrome coronavirus 2, Ventilation
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