Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Acetate- vs lactate-buffered crystalloid solutions: Protocol for a systematic review with meta-analysis and trial sequential analysis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Anesthesiologists’ airway management expertise: Identifying subjective and objective knowledge gaps

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Characteristics, interventions and longer-term outcomes of COVID-19 ICU patients in Denmark - a nationwide, observational study

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Risk factors for long-term cognitive impairment in ICU survivors: A multicenter, prospective cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Acetate- vs lactate-buffered crystalloid solutions: Protocol for a systematic review with meta-analysis and trial sequential analysis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Characteristics, interventions and longer-term outcomes of COVID-19 ICU patients in Denmark - a nationwide, observational study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Clinical validation of precision medicine protocols: the last mile is the longest

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Higher vs Lower Oxygenation Strategies in Acutely Ill Adults: A Systematic Review With Meta-Analysis and Trial Sequential Analysis

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Invasive aspergillosis in patients with severe COVID-19 pneumonia

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

Introduction: Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists. Methods: The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals. Discussion: The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Volume64
Issue number9
Pages (from-to)1365-1375
Number of pages11
ISSN0001-5172
DOIs
Publication statusPublished - 1 Oct 2020

Bibliographical note

© 2020 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

ID: 60645269