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RANDOMIZED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF OUTPATIENT TREATMENTS IN INDIVIDUALS WITH COVID-19 WITH RISK FACTORS. COVERAGE FRANCE TRIAL: A STRUCTURED SUMMARY

Racha Onaisi 1 Alexandre Duvignaud 2, 3 Antoine Nguyen Binh 4 Julie Dupouy 5, 6 Julie Chastang 4, 7 Josselin Le Bel 8 Roland Landman 8, 9 Jean Marc Naccache 10 Benjamin Lefèvre 11 Lionel Piroth 12, 13 C Binquet 13, * Alain Makinson 14 Thomas Darnaud 15 Cyril Begue 16 Laurence Weiss 17 Laura Richert 18, 19 Xavier Anglaret 2 Malvy Denis 3, 2 Jean Philippe Joseph 18 Pierre Louis Druais 20 David Darmon 21, 22, * Cedric Ral 23, 24 Edouard Lhomme 18, 19 Olivier Saint-Lary 25 
* Corresponding author
19 SISTM - Statistics In System biology and Translational Medicine
Inria Bordeaux - Sud-Ouest, BPH - Bordeaux population health
Abstract : Context. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.
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https://www.hal.inserm.fr/inserm-03647560
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Submitted on : Wednesday, April 20, 2022 - 4:20:59 PM
Last modification on : Saturday, June 25, 2022 - 3:53:12 AM

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  • HAL Id : inserm-03647560, version 1

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Racha Onaisi, Alexandre Duvignaud, Antoine Nguyen Binh, Julie Dupouy, Julie Chastang, et al.. RANDOMIZED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF OUTPATIENT TREATMENTS IN INDIVIDUALS WITH COVID-19 WITH RISK FACTORS. COVERAGE FRANCE TRIAL: A STRUCTURED SUMMARY. Exercer, 2021, 178, pp.451-458. ⟨inserm-03647560⟩

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