A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of
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LETTER
Open Access
A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARSCoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER): A structured summary of a study protocol for a randomised controlled trial Maike Janssen1*, Ulrike Schäkel1, Carine Djuka Fokou2, Johannes Krisam3, Jacek Stermann3, Katharina Kriegsmann1, Isabella Haberbosch1, Jan Philipp Novotny1, Stefan Weber4, Maria Vehreschild4,5, Martin Bornhäuser6, Lars Bullinger7, Michael Schmitt1, Tobias Liebregts1, Peter Dreger1, Hanns-Martin Lorenz1, Anna Plaszczyca8, Ralf Bartenschlager8, Barbara Müller9, Hans-Georg Kräusslich9, Niels Halama10, Dirk Jäger10, Richard F. Schlenk1,2,10, Albrecht Leo11, Stefan Meuer11, Markus A. Weigand12, Johann Motsch12, Uta Merle13, Claudia M. Denkinger4 and Carsten Müller-Tidow1
Abstract Objectives: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. (Continued on next page)
* Correspondence: [email protected] 1 Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany Full list of author information is available at the end of the article
© The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Janssen et al. Trials
(2020) 21:828
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• To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. Trial design: Randomised, open-label, multicenter phase II tria
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