Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial
| Autor: | Bruno François, Stephan Ehrmann, Caroline Caille-Fénérol, N Heming, Sarah Zohar, Gaëtan Plantefève, Julio Badie, Antoine Guillon, Amélie Le Gouge, Youenn Jouan, Guillaume Voiriot, Bruno Giraudeau, Carine Coffre, Ferhat Meziani, Jean-Damien Ricard, Marie Leclerc, Hélène Bourgoin, Pierre-François Dequin, Djillali Annane, Cécile Aubron, Céline Lengellé, Elsa Tavernier |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Hydrocortisone medicine.medical_treatment Secondary infection Critical Illness Pneumonia Viral Anti-Inflammatory Agents Placebo 01 natural sciences law.invention 03 medical and health sciences Betacoronavirus 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine Oxygen therapy medicine Extracorporeal membrane oxygenation Humans 030212 general & internal medicine Treatment Failure 0101 mathematics Adverse effect Pandemics Aged Original Investigation Mechanical ventilation business.industry SARS-CoV-2 010102 general mathematics Oxygen Inhalation Therapy COVID-19 General Medicine Middle Aged Intensive care unit Respiration Artificial 3. Good health COVID-19 Drug Treatment Early Termination of Clinical Trials Female business Coronavirus Infections Respiratory Insufficiency |
| Zdroj: | JAMA |
| ISSN: | 1538-3598 |
| Popis: | Importance Coronavirus disease 2019 (COVID-19) is associated with severe lung damage. Corticosteroids are a possible therapeutic option. Objective To determine the effect of hydrocortisone on treatment failure on day 21 in critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure. Design, Setting, and Participants Multicenter randomized double-blind sequential trial conducted in France, with interim analyses planned every 50 patients. Patients admitted to the intensive care unit (ICU) for COVID-19–related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020. The study intended to enroll 290 patients but was stopped early following the recommendation of the data and safety monitoring board. Interventions Patients were randomized to receive low-dose hydrocortisone (n = 76) or placebo (n = 73). Main Outcomes and Measures The primary outcome, treatment failure on day 21, was defined as death or persistent dependency on mechanical ventilation or high-flow oxygen therapy. Prespecified secondary outcomes included the need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2ratio measured daily from day 1 to day 7, then on days 14 and 21; and the proportion of patients with secondary infections during their ICU stay. Results The study was stopped after 149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled. One hundred forty-eight patients (99.3%) completed the study, and there were 69 treatment failure events, including 11 deaths in the hydrocortisone group and 20 deaths in the placebo group. The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, –8.6% [95.48% CI, –24.9% to 7.7%];P = .29). Of the 4 prespecified secondary outcomes, none showed a significant difference. No serious adverse events were related to the study treatment. Conclusions and Relevance In this study of critically ill patients with COVID-19 and acute respiratory failure, low-dose hydrocortisone, compared with placebo, did not significantly reduce treatment failure (defined as death or persistent respiratory support) at day 21. However, the study was stopped early and likely was underpowered to find a statistically and clinically important difference in the primary outcome. Trial Registration ClinicalTrials.gov Identifier:NCT02517489 |
| Databáze: | OpenAIRE |
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