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

NCT04356495 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Corona Virus Infection
  • Sars-CoV2

Interventions

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

Sponsors & Collaborators

  • University of Bordeaux

    collaborator OTHER

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Denis MALVY, Pr · University Hospital, Bordeaux

  • Xavier ANGLARET, Dr · Inserm 1219

  • Laura RICHERT, Dr · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-10-08
Completion
2021-10-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356495 on ClinicalTrials.gov