Title {1} | Value of early treatment with polyvalent immunoglobulin in the management of acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): protocol for a randomized controlled trial |
Trial registration {2a and 2b}. |
EudraCT number: 2020-001570-30 Clinicaltrials.gov id NCT04350580 on 17 April 2020 |
Protocol version {3} | Version 4.1– 19.10.2020 |
Funding {4} | This trial is funded by the Programme Hospitalier de Recherche Clinique. The Laboratoire Français du Biofranctionnement (LFB) provided the drugs at no-cost. |
Author details {5a} |
Aurélien Mazeraud, GHU Paris Psychiatrie et Neurosciences, Service de Neuroanesthésie et Neuroréanimation. Université de Paris, Paris Bruno Gonçalves, GHU Paris Psychiatrie et Neurosciences, and Paulo Niemeyer State Brain Institute, Rio de Janeiro, Brazil Philippe Aegerter, Methodology Unit, GIRCI-IdF, 75019 Paris, France, and Université Paris-Saclay, UVSQ, Univ. Paris-Sud, Inserm, Équipe d’Épidémiologie respiratoire intégrative, U1018 CESP, 94807, Villejuif, France Letizia Mancusi, GHU Paris Psychiatrie et Neurosciences Christine Rieu, GHU Paris Psychiatrie et Neurosciences Fernando Bozza, D’Or Institute for Research and Education, Rio de Janeiro, Brazil Khaoussou Sylla, GHU Paris Psychiatrie et Neurosciences Shidasp Siami, MD, PhD, CH Sud Essonnes Réanimation polyvalente Tarek Sharshar, GHU Paris Psychiatrie et neurosciences, Service de Neuroanesthésie et Neuroréanimation. Université de Paris, Paris |
Name and contact information for the trial sponsor {5b} | Dr Sylla Khaoussou |
Role of sponsor {5c} |
The LFB did not have any role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. GHU Paris Psychiatrie et Neurosciences was in charge of the data collection, monitoring and management. |