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: 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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