Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protoco
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LETTER
Open Access
Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial) Alexandre Duvignaud1,2*† , Edouard Lhomme3,4,5†, Thierry Pistone1,2, Racha Onaisi6, Rémi Sitta3,5, Valérie Journot2, Duc Nguyen1,2, Nathan Peiffer-Smadja7,8,9, Antoine Crémer10,11, Stéphane Bouchet11,12, Thomas Darnaud13, Delphine Poitrenaud14, Lionel Piroth15,16, Christine Binquet17, Jean-François Michel18,19, Benjamin Lefèvre20, David Lebeaux21, Josselin Lebel22,23, Julie Dupouy24,25,26,27, Caroline Roussillon28, Anne Gimbert29, Linda Wittkop5,30, Rodolphe Thiébaut3,4,5, Joanna Orne-Gliemann2, Jean-Philippe Joseph31, Laura Richert3,4,5†, Xavier Anglaret2†, Denis Malvy1,2† and the COVERAGE study group
Abstract Objectives: To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation. Trial design: Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: (Continued on next page)
* Correspondence: [email protected] The entire COVERAGE study group is listed in the Additional file 3. † Alexandre Duvignaud, Edouard Lhomme, Laura Richert, Xavier Anglaret and Denis Malvy contributed equally to this work. 1 CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000 Bordeaux, France 2 Inserm U1219, Univ. Bordeaux, IRD, F-33000 Bordeaux, France 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.
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