학술논문
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)
Document Type
article
Author
Alexandre Duvignaud; Edouard Lhomme; Thierry Pistone; Racha Onaisi; Rémi Sitta; Valérie Journot; Duc Nguyen; Nathan Peiffer-Smadja; Antoine Crémer; Stéphane Bouchet; Thomas Darnaud; Delphine Poitrenaud; Lionel Piroth; Christine Binquet; Jean-François Michel; Benjamin Lefèvre; David Lebeaux; Josselin Lebel; Julie Dupouy; Caroline Roussillon; Anne Gimbert; Linda Wittkop; Rodolphe Thiébaut; Joanna Orne-Gliemann; Jean-Philippe Joseph; Laura Richert; Xavier Anglaret; Denis Malvy; the COVERAGE study group
Source
Trials, Vol 21, Iss 1, Pp 1-3 (2020)
Subject
Language
English
ISSN
1745-6215
Abstract
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: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial. Participants Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate 5.5 mmol/L or