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

Dec 22, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Trial Sponsor:
Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium by the European Union and others.
Date Published:
12/20/2023
Date Updated:
12/22/2023
Original Posted Date:
12/21/2023
References

Contribution To Literature:

The REMAP-CAP (simvastatin) trial failed to show that simvastatin improves outcomes among patients with moderate to severe COVID-19 infection.

Description:

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

Study Design

  • Randomized
  • Parallel

Patients with moderate to severe COVID-19 infection were randomized to simvastatin 80 mg (n = 1,846) vs. control (n = 842).

  • Total number of enrollees: 2,688
  • Duration of follow-up: median 90 days
  • Mean patient age: 56 years
  • Percentage female: 33%
  • Percentage with diabetes: 16%

Inclusion criteria:

  • Patients ≥18 years of age with moderate to severe COVID-19 infection

Exclusion criteria:

  • Current statin therapy
  • Severe liver disease
  • Creatinine level >2.26 mg/dL unless on dialysis

Principal Findings:

Enrollment was closed early due to low event rates.

The primary outcome, median number of organ support–free days, was 11 in the simvastatin group vs. 7 in the control group (95% credible interval 0.98-1.34).

Secondary outcomes:

  • Serious adverse events: 3.1% in the simvastatin group vs. 2.0% in the control group

Interpretation:

Among patients hospitalized with moderate to severe COVID infection, simvastatin 80 mg compared with control failed to improve outcomes. Serious adverse events were slightly higher in the simvastatin group. This trial was terminated early due to a low rate of COVID infections. A separate trial from the REMAP-CAP investigators failed to find benefit for corticosteroids among patients hospitalized with moderate to severe COVID infection.

References:

The REMAP-CAP Investigators. Simvastatin in Critically Ill Patients With Covid-19. N Engl J Med 2023;389:2341-54.

Editorial: Moskowitz A, Gong MN. Balancing Act — Probability, Precision, and the Future of Critical Care Trials in ARDS. N Engl J Med 2023;389:2391-2.

Clinical Topics: COVID-19 Hub, Dyslipidemia, Statins, Prevention

Keywords: COVID-19, Simvastatin


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