Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia - REMAP-CAP

Sep 08, 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:
Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium by the European Union and others.
Date Published:
09/02/2020
Date Updated:
09/08/2020
Original Posted Date:
09/08/2020
References

Contribution To Literature:

The REMAP-CAP trial failed to show possible benefit for corticosteroids with moderate to severe COVID-19 infection.

Description:

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

Study Design

  • Randomized
  • Parallel
  • Open-label

Eligible patients were randomized to fixed-dose hydrocortisone (n = 143) versus shock-dose hydrocortisone (n = 152) versus usual care (n = 108).

In the fixed-dose group, subjects received intravenous hydrocortisone 50 mg every 6 hours for 7 days. In the shock-dose group, subjects received intravenous hydrocortisone 50 mg every 6 hours while in shock.

  • Total number of enrollees: 403
  • Duration of follow-up: 21 days
  • Mean patient age: 60 years
  • Percentage female: 29%
  • Percentage with diabetes: 39%

Inclusion criteria:

  • Moderate to severe COVID-19 infection requiring intensive care unit (ICU) support

Exclusion criteria:

  • Imminent death
  • Hypersensitivity to hydrocortisone
  • Systemic hydrocortisone use

Principal Findings:

The primary outcome, median organ support-free days up to day 21, was 0 in the fixed-dose hydrocortisone group compared with 0 in the shock-dose hydrocortisone group compared with 0 in the usual care group (p = nonsignificant).

Secondary outcomes:

  • In-hospital deaths: 30% in the fixed-dose hydrocortisone group compared with 26% in the shock-dose hydrocortisone group compared with 33% in the usual care group (p = nonsignificant)

Interpretation:

This trial was terminated early after the release of another trial. In the current trial, among patients with moderate to severe COVID-19 infection, hydrocortisone was not beneficial compared with usual care. Limitations of the current trial are early termination and open-label design.

References:

Angus DC, Derde L, Al-Beidh F, et al., on behalf of the REMAP-CAP Investigators. Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial. JAMA 2020;Sep 2:[Epub ahead of print].

Editorial: Prescott HC, Rice TW. Corticosteroids in COVID-19 ARDS: Evidence and Hope During the Pandemic. JAMA 2020;Sep 2:[Epub ahead of print].

Clinical Topics: COVID-19 Hub, Prevention

Keywords: Coronavirus, Coronavirus Infections, COVID-19, Hydrocortisone, Intensive Care Units, Oxygen Inhalation Therapy, Pneumonia, Primary Prevention, Respiration, Artificial, severe acute respiratory syndrome coronavirus 2, Shock, Treatment Outcome


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