Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19A Randomized Clinical Trial

Corresponding Author: Pierre-François Dequin, MD, PhD, Service de Médecine Intensive–Réanimation, hôpital Bretonneau, 37044 Tours CEDEX 09, France (dequin@univ-tours.fr).

Accepted for Publication: August 18, 2020.

Published Online: September 2, 2020. doi:10.1001/jama.2020.16761

Author Contributions: Dr Dequin had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr Annane and Ms Le Gouge have contributed equally.

Concept and design: Dequin, Ehrmann, Tavernier, Zohar, Giraudeau, Le Gouge.

Acquisition, analysis, or interpretation of data: Dequin, Heming, Meziani, Plantefeve, Voiriot, Badie, François, Aubron, Ricard, Ehrmann, Jouan, Guillon, Leclerc, Coffre, Lengellé, Caille-Fenérol, Giraudeau, Annane, Le Gouge.

Drafting of the manuscript: Dequin.

Critical revision of the manuscript for important intellectual content: Dequin, Heming, Meziani, Plantefeve, Voiriot, Badie, François, Aubron, Ricard, Ehrmann, Jouan, Guillon, Leclerc, Coffre, Lengellé, Caille-Fenérol, Tavernier, Zohar, Giraudeau, Annane, Le Gouge.

Statistical analysis: Tavernier, Zohar, Giraudeau, Le Gouge.

Obtained funding: Dequin, Guillon, Annane.

Administrative, technical, or material support: Dequin, Badie, Aubron, Ehrmann, Jouan, Guillon, Leclerc, Caille-Fenérol.

Supervision: Dequin, Meziani.

Other - patient recruitment: Ricard.

Conflict of Interest Disclosures: Dr Dequin reported receiving grants from Abionic, Atox Bio, Sphingotec GMBH, Adrenomed, Medspace, Aridis, Merck, Combioxin, GlaxoSmithKline, MedImmune, Genentech INH, RevImmune, Faron, Kenta, and Tigenix. Dr Voiriot reported receiving personal fees from BioMérieux and receiving grants from BioMérieux, SOS Oxygène, and Janssen. Dr Ricard reported receiving grants from Fisher & Paykel. Dr Ehrmann reported receiving grants from Aerogen and Fisher & Paykel; personal fees from Aerogen and La Diffusion Technique Française; and nonfinancial support from Aerogen, Fisher & Paykel, and La Diffusion Technique Française. Dr Annane reported receiving a grant from the French Ministry of Health through the Programme National de Recherche Clinique to implement the REMAPCAP platform in France, which has a corticosteroid domain. No other authors reported disclosures.

Funding/Support: This study was funded by the French Ministry of Health, Programme Hospitalier de Recherche Clinique (PHRC) (2014 [CAPE COD parent trial], 2020 [CAPE COVID subtrial]).

Role of the Funder/Sponsor: The French Ministry of Health PHRC had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

CAPE COVID Trial Investigators: Pierre Moine, MD, PhD, Virginie Maxime, MD, Bernard Clair, MD, Rania Bounab, MD, Francesca Santi, MD, David Orlikowski, MD, PhD (Médecine Intensive Réanimation, Hôpital Raymond Poincaré, Garches, France); Julie Helms, MD, PhD, Raphaël Clere-Jehl, MD, Hassene Rahmani, MD, Alexandra Monnier, MD, Hamid Merdji, MD, Antoine Studer, MD, Jessy Cattelan, MD (Médecine Intensive Réanimation, Nouvel Hôpital Civil, Strasbourg, France); Laetitia Bodet-Contentin, MD, PhD, Walid Darwiche, MD, Denis Garot, MD, Annick Legras, MD, Stefan Mankikian, MD, Emmanuelle Mercier, MD, PhD, Marlène Morisseau, MD, Yonatan Perez, MD, Charlotte Salmon-Gandonnière, MD, PhD (Médecine Intensive-Réanimation, hôpital Bretonneau, Tours, France); Damien Contou, MD, Elsa Logre, MD, Radj Cally, MD, Mégan Fraisse, MD, Hervé Mentec, MD, Olivier Pajot, MD (Réanimation polyvalente, Hôpital Victor Dupouy, Argenteuil, France); Muriel Fartoukh, MD, PhD, Vincent Labbé, MD, Michel Djibré, MD, Aude Gibelin, MD, Clarisse Blayau, MD, Enora Berti, MD, Paris Meng, MD, Julien Lopinto, MD, Matthieu Turpin, MD, Alexandre Elabbadi, MD (Médecine Intensive Réanimation, Hôpital Tenon, Paris, France); Fernando Berdaguer-Ferrari, MD (Réanimation Polyvalente, Hôpital Nord Franche-Comté, Trevenans, France); Arnaud Desachy, MD, Guillaume Gilbert, MD, Marine Goudelin, MD, Bruno Evrard, MD, Thomas Daix, MD, Anne-Laure Fedou, MD, Philippe Vignon, MD, PhD (Réanimation Polyvalente, Hôpital Dupuytren, Limoges, France); Erwan L’Her, MD, PhD, Nicolas Ferrière, MD, Laetitia Bodenes, MD, Pierre Bailly, MD, Gwénaël Prat, MD, Jean-Marie Tonnelier, MD, Anne Renault, MD, Christelle Teiten, MD (Médecine Intensive Réanimation, Hôpital de la Cavale Blanche, Brest, France); Damien Roux, MD, PhD, Sébastien Besset, MD, Louis Marie Dumont, MD, Laura Fedirici, MD, Marc Amouretti, MD, Noémie Zucman, MD, Santiago Freita, MD, Didier Dreyfuss, MD, PhD (Médecine Intensive Réanimation, Hôpital Louis Mourier, Colombe, France). None of these individuals received compensation for their role in the study.

Members of the CRICS-TriGGERSep Network: See Supplement 3.

Data Sharing Statement: See Supplement 4.

Additional Contributions: We thank the members of the data and safety monitoring board for their commitment and responsiveness: Jean Chastre, MD (Assistance Publique–Hôpitaux de Paris, France); Béatrice Guyomarch, MSc (Centre Hospitalier Universitaire de Nantes, France); Liem Binh Luong Nguyen, MD, PhD (Assistance Publique–Hôpitaux de Paris, France); Sylvain Marchand-Adam, MD, PhD (Centre Hospitalier Universitaire de Tours, France); Véronique Sébille, PhD (Centre Hospitalier Universitaire de Nantes, France). None of these individals received compensation for their role in the study.