Title {1} | A randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) study to evaluate the safety and efficacy of XAV-19 in patients with COVID-19 induced moderate pneumonia |
Trial registration {2a and 2b} | Registration number NCT04453384, first published on July 1, 2020. https://clinicaltrials.gov/ct2/show/NCT04453384 and EudraCT number 2020-002574-27, first published on June 15, 2020. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002574-27/FR |
Protocol version {3} | The updated protocol is at version 1.4 on August 4, 2020. |
Funding {4} | This study is supported by Public Investment Bank, also known as BPI France in the framework of the “Investment for the Future” programme (Programme d’Investissements d’Avenir). |
Author detail {5a} | Benjamin Gaborit, Pascale Morineau, Jeremie Orain, Morgane Le Bras and François Raffi belong to the CHU Nantes, Department of Infectious Disease and the Clinical Investigation Centre CIC1413 (INSERM and CHU Nantes). Alexandra Poinas belongs exclusively to the Clinical Investigation Centre CIC1413 (INSERM and CHU Nantes). Marie-Anne Vibet; Aurélie Le Thuaut, Laetitia Berly, Anne Omnes and Alexandra Jobert belong to the CHU Nantes, Sponsor Department. The other authors belonging to the Nantes University Hospital are Karine Botturi (Partnership and Innovation Department), Regis Josien (Immunology laboratory), Sophie Brouard and Nicolas Degauque (Center of Research in Transplantation and Immunology) Virginie Ferré (Virology Laboratory) and Laurent Flet (Pharmacy department). Odile Duvaux and Bernard Vanhove belong to the Xenothera Laboratory. Florence Ader, Karine Lacombe and Vincent Dubee are principal investigators, belong respectively to the Lyon University Hospital (Hospices Civils de Lyon), AP-HP (Saint-Antoine Hospital) and Angers University Hospital. Eric Vicaut belongs to AP-HP, Fernand Widal Hospital. |
Name and contact information for the trial Sponsor {5b} | Karine Botturi and Laetitia Berly are the sponsor project managers and they manage the logistics of the trial. Any request for POLYCOR information can be made via this e-mail address: BP-direction-de-la-recherche@chu-nantes.fr. |
Role of sponsor {5c} |
All the submissions/declarations were made by the Sponsor Department at CHU Nantes, which of course manages the quality of the data collected. The data collected during the study will be processed electronically in accordance with the requirements of the CNIL, the French Data Protection Authority and with the European and French regulations regarding the safety concerns. Requests for substantial modifications of the protocol should be addressed by the sponsor for approval or notification to French regulatory authorities and/or the Ethical Review Board concerned in compliance with Law 2004-806 of 9 August, 2004 and its implementing decrees. |