FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial.

"Declarations Ethics approval and consent to participateThe 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. Consent for publicationNot applicable. Competing interestsDr 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. Competing interests 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."

"Funding The sponsor was Assistance Publique–Hôpitaux de Paris (Direction de la Recherche Clinique et de l’Innovation). Funding sources were donations from Sanofi SA, Paris, France; Bouygues SA, Paris, France; F4-Pharma Ges.m.b.H., Vienna, Austria, and Charles-Henri Hirsch. F4-Pharma Ges.m.b.H., Vienna, Austria, provided the drug. The funding organization 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."

"Trial registration NCT04618042. Registered 5 November 2020."