Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 1057
Summary
- Conditions
- Corona Virus Infection
- SARS COV2
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multicenter, randomized, controlled clinical trial with for each drug : A safety study pilot phase. An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the efficacy phase. Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
COVERAGE France is Multicenter, randomized, controlled clinical trial with for each drug : A safety study pilot phase. An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the effic...
COVERAGE France is Multicenter, randomized, controlled clinical trial with for each drug : A safety study pilot phase. An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the efficacy phase. Pilot phase will evaluate the tolerance of experimental treatments for drugs given for the first time ("first in home-based care") in ambulatory individuals with COVID-19 with aggravating risk factors. Efficacy Phase: To estimate the effectiveness of experimental ambulatory treatments, compared to vitamin supplementation, in reducing the risk of hospitalization, oxygen therapy indication or death in ambulatory individuals with COVID-19 with aggravating risk factors. The trial is a national platform with the vocation to open as many centers as possible, subject to criteria set by the Scientific Advisory Board.
Tracking Information
- NCT #
- NCT04356495
- Collaborators
- University of Bordeaux
- Investigators
- Principal Investigator: Denis MALVY, Pr University Hospital, Bordeaux Study Director: Xavier ANGLARET, Dr Inserm 1219 Study Chair: Laura RICHERT, Dr University Hospital, Bordeaux
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