Higher vs lower doses of dexamethasone in patients with COVID-19 and severe hypoxia (COVID STEROID 2) trial: Protocol

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M W Munch1,2, Anders Granholm1,2, S N Myatra3

  • 1Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Acta Anaesthesiologica Scandinavica
|February 14, 2021
PubMed

Insights

The COVID STEROID 2 trial compares higher versus lower doses of dexamethasone in severe COVID-19 patients. This study will determine the optimal corticosteroid dosage for improved patient outcomes and reduced mortality.

Area of Science:

  • Critical Care Medicine
  • Infectious Diseases
  • Clinical Trials

Background:

  • The COVID-19 pandemic caused millions of deaths and overwhelmed healthcare systems globally.
  • Systemic low-dose corticosteroids benefit severe COVID-19 patients, but optimal dosing remains unclear.
  • Higher corticosteroid doses are used for other lung diseases, suggesting potential benefits in COVID-19.

Purpose of the Study:

  • To compare the efficacy and safety of higher (12 mg) versus lower (6 mg) doses of dexamethasone in adults with COVID-19 and severe hypoxia.
  • To determine the optimal corticosteroid regimen for critically ill COVID-19 patients.

Main Methods:

  • The COVID STEROID 2 trial is an international, blinded, randomized controlled trial.
  • Enrolling 1,000 patients with severe hypoxia due to COVID-19 across Denmark, Sweden, Switzerland, and India.
  • Primary outcome: days alive without life support by day 28; secondary outcomes include mortality and quality of life.

Main Results:

  • Primary outcome analysis will use the Kryger Jensen and Lange test, adjusted for stratification variables.
  • Results will be reported as adjusted mean and median differences.
  • The study protocol details the full statistical analysis plan.

Conclusions:

  • The COVID STEROID 2 trial will provide crucial evidence on optimal systemic corticosteroid dosing for severe hypoxic COVID-19 patients.
  • Findings will have significant implications for patient care, families, and public health strategies.
  • This research aims to optimize treatment protocols for a major global health crisis.
Abstract

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