NCT04356495

Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation

Randomized Trial to Evaluate the Safety and Efficacy of Outpatient Treatments to Reduce the Risk of Worsening in Individuals With COVID-19 With Risk Factors (COVERAGE France)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.

Detailed 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 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.

Conditions

• Corona Virus Infection
• Sars-CoV2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamins	2 tablets daily from the first day (day 0) to day 9
DRUG	Telmisartan	1 tablet daily from the first day (day 0) to day 9
DRUG	Ciclesonide	2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
DRUG	interferon β-1b	A 10-minute nebulization, once a day, from the first day (day 0) to day 4, of 9.6 MIU / 300 µg of IFN-β-1b (EXTAVIA®) diluted in 2 mL of water

Timeline

• Start date: 2020-07-29
• Primary completion: 2021-10-08
• Completion: 2021-10-22
• First posted: 2020-04-22
• Last updated: 2022-02-04

Locations

7 sites across 1 country: France