Randomized Evaluation of COVID-19 Therapy - RECOVERY (Hydroxychloroquine)

Nov 19, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
UK Research and Innovation, National Institute for Health Research, and others
Date Published:
10/08/2020
Date Updated:
11/19/2020
Original Posted Date:
10/13/2020
References

Contribution To Literature:

The RECOVERY (hydroxychloroquine) trial failed to show that hydroxychloroquine was superior to usual care at improving survival in hospitalized COVID-19 patients.

Description:

The goal of the trial was to evaluate hydroxychloroquine compared with usual care among patients admitted to the hospital with coronavirus disease 2019 (COVID-19) infection.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients admitted to the hospital with COVID-19 infection were randomized to hydroxychloroquine 800 mg at baseline, 800 mg at 6 hours, 400 mg at 12 hours, then 400 mg twice daily for 9 days or until hospital discharge (n = 1,561) versus usual care (n = 3,155).

  • Total number of enrollees: 4,716
  • Duration of follow-up: 28 days
  • Mean patient age: 65 years
  • Percentage female: 39%
  • Percentage with diabetes: 27%

Inclusion criteria:

  • Patients admitted to the hospital with COVID-19 infection

Exclusion criteria:

  • Severe hepatic insufficiency
  • Use of medicinal products highly dependent on cytochrome P450 3A4 for clearance

Principal Findings:

The primary outcome, death, all-cause mortality at 28 days, occurred in 27% of the hydroxychloroquine group compared with 25% of the usual care group (p = 0.15). Results were the same in all subgroups.

Secondary outcomes:

  • Discharge from the hospital within 28 days: 60% of the hydroxychloroquine group compared with 63% of the usual care group (p < 0.05)
  • Need for mechanical ventilation within 28 days: 31% of the hydroxychloroquine group compared with 27% of the usual care group (p < 0.05)

Interpretation:

Among patients admitted to the hospital with COVID-19 infection, hydroxychloroquine was not superior compared with usual care. Hydroxychloroquine did not improve survival compared with usual care. Hydroxychloroquine was actually associated with a lower frequency of discharge from the hospital and an increased incidence in mechanical ventilation compared with placebo. Multiple randomized trials have now confirmed the lack of efficacy for hydroxychloroquine compared with usual care among patients hospitalized with COVID-19 infection.

References:

The RECOVERY Collaborative Group. Effect of Hydroxychloroquine in Hospitalized Patients With Covid-19. N Engl J Med 2020;383:2030-40.

Clinical Topics: COVID-19 Hub, Prevention, Novel Agents, Statins

Keywords: Antiviral Agents, Coronavirus, COVID-19, Hospitalization, Hydroxychloroquine, Patient Discharge, Primary Prevention, Respiration, Artificial, severe acute respiratory syndrome coronavirus 2


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