Guérin, Emmanuelle
Belin, Lisa
Franchineau, Guillaume
Le Guennec, Loïc
Hajage, David
Diallo, Mamadou Hassimiou
Frapard, Thomas
Le Fèvre, Lucie
Luyt, Charles-Edouard
Combes, Alain
Germain, Stéphane
Hayon, Jan
Asfar, Pierre
Bréchot, Nicolas
Article History
Received: 9 February 2023
Accepted: 16 August 2023
First Online: 29 August 2023
Declarations
:
: The independent ethics review board CPP Ouest VI, Brest, France, approved the trial protocol (CPP 1306-EudraCT 2020-002056-20/RIPH 20.06.15.56627). The trial was conducted in accordance with the ethical principles of the Declaration of Helsinki, the International Conference on Harmonisation–Good Clinical Practice (ICH-GCP) guideline, the Quality Management Standards for Drug Clinical Trials of the French Food and Drug Administration (ANSM, Agence Nationale de Sécurité du Médicament et des Produits de Santé). According to the specifications of emergency consent, randomization without a close relative or surrogate consent could be performed, but informed consent by the patient or patient’s relatives was obtained for all patients.
: Not applicable.
: Dr Bréchot is on the F4-Pharma advisory board, without any financial competing interest. He received a grant from the French Ministry of Health for another study evaluating FX06. He receives fees from Findimmune, outside the scope of this study. Dr Luyt reported receiving grants from French Ministry of Health during the conduct of the study; personal fees from Bayer Healthcare, Carmat, Faron, Merck Sharp & Dohme, ThermoFisher Brahms, and BioMérieux, outside the submitted work. Dr. Combes reports receiving grant support and lecture fees from Maquet and Baxter, and consulting fees from Hemovent.