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Corona Virus InfectionPhase 2/3COVERAGEFranceNCT04356495

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

A Phase 2/3 study testing Vitamins, Telmisartan and Ciclesonide in people with Corona Virus Infection and Sars-CoV2, run by University Hospital, Bordeaux at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Corona Virus Infection, Sars-CoV2
What is being tested?
Vitamins, Telmisartan and Ciclesonide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
412 participants
Where
7 sitesFrance
Study dates
29 Jul 2020to 22 Oct 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical picture suggestive of COVID-19 dated 7 days or less.
  • Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.
  • Absence of criteria for hospitalization or oxygen therapy according to current recommendations.
  • Age :
  • greater than or equal to 60 years of age without any risk factor
  • or between 50 and 59 years of age and the presence of at least one of the following risk factors :
Show all 21Show fewer
  • Arterial hypertension under treatment (all stages)
  • Obesity (BMI ≥30 kg/m2)
  • Diabetes under treatment (all types)
  • Ischemic heart disease (all stages)
  • Heart failure (all stages)
  • Stroke History
  • Chronic Obstructive Pulmonary Disease (all stages)
  • Stage 3 chronic renal failure (30 ≤ Estimated GFR < 60 mL/min/1.73 m²)
  • Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.
  • Immunodeficiency
  • of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids > 15 mg/d of prednisone equivalent taken for at least 2 months);
  • HIV infection with CD4<200/mm3.
  • Valid, ambulatory person, fully able to understand the issues of the trial
  • Beneficiary of a Social Security scheme
  • Signed informed consent

Who cannot join

  • Asymptomatic person
  • Inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship)
  • Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • Bordeaux university Hospital

    Bordeaux, 33000

  • CHU de Dijon-Bourgogne

    Dijon

  • CHU de Montpellier

    Montpellier, 34295

  • CHRU de Nancy

    Nancy

  • Groupe hospitalier Paris Saint Joseph

    Paris, 75014

  • CNGE

    Paris

  • CHU de Toulouse

    Toulouse

Other trials in France

About this study

Official title: 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)

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.

Read the 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.

Being tested
Vitamins, Telmisartan, Ciclesonide, interferon β-1b
Keywords
Corona virus, Sars-CoV2, telmisartan, ciclesonide, interferon β-1b
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VitaminsDietary supplement

    2 tablets daily from the first day (day 0) to day 9

  • TelmisartanDrug

    1 tablet daily from the first day (day 0) to day 9

  • CiclesonideDrug

    2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9

  • interferon β-1bDrug

    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

Study groups in NCT04356495
Study groupRoleWhat they receive
VitaminsSham comparatorPatients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
Receives: Dietary Supplement: Vitamins
TelmisartanExperimentalPatients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
Receives: Drug: Telmisartan
CiclesonideExperimentalPatients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days
Receives: Drug: Ciclesonide
interferon β-1bExperimentalPatients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
Receives: Drug: interferon β-1b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event

    Measured: From inclusion (day0) to day 14

  2. Efficacy phase: Death

    Proportion of participants with an occurrence of death

    Measured: From inclusion (day0) to day 14

  3. Efficacy phase: oxygen therapy

    Proportion of participants who had an indication for oxygen therapy

    Measured: From inclusion (day0) to day 14

  4. Efficacy phase: hospitalization

    Proportion of participants who had an indication for hospitalization

    Measured: From inclusion (day0) to day 14

Secondary outcomes (12)

  1. Proportion of hospitalizations, overall and by cause, in each group

    Measured: From inclusion (day0) to day 28

  2. Death and causes of death

    Proportion of deaths, overall and by cause, in each group

    Measured: From inclusion (day0) to day 28

  3. Proportion of intensive care hospitalizations, overall and by cause, in each group

    Measured: From inclusion (day0) to day 28

  4. Proportion of participants with negative SARS-CoV-2 RT-PCR

    Measured: day 7

  5. Haematological markers evolution

    Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR

    Measured: from inclusion (day 0) to day 7

  6. Inflammatory markers evolution

    Evolution of Inflammatory markers in each group : PCT, CRP

    Measured: from inclusion (day 0) to day 7

  7. Adverse events

    Number and proportion of grade 1,2,3,4 adverse events in each group

    Measured: from inclusion (day 0) to day 28

  8. Adverse reactions

    Number and proportion of grade 1,2,3,4 adverse events in each group

    Measured: from inclusion (day 0) to day 28

  9. Acceptability of the treatment

    Acceptability of the treatment by participant will be assessed with an interview

    Measured: from inclusion (day 0) to day 10

  10. Antibiotic consumption

    Proportion of participants who received at least one day of antibiotic therapy

    Measured: from inclusion (day 0) to day 28

  11. Oxygen saturation worsening

    Proportion of participants who experienced a worsening of oxygen saturation

    Measured: from inclusion (day 0) to day 28

  12. protocol follow-up

    Proportion of participants who completed the prescribed protocol treatment

    Measured: from inclusion (day 0) to day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start29 Jul 2020
  3. Primary completion8 Oct 2021
  4. Study completion22 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356495
Sponsor's protocol ID
CHUBX 2020/12
Other IDs
2020-001435-27
Acronym
COVERAGEFrance
Status last verified
Feb 2022
First submitted
11 Apr 2020
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Garcia G, Labrouche-Colomer S, Duvignaud A, Clequin E, Dussiau C, Tregouet DA, Malvy D, Prevel R, Zouine A, Pellegrin I, Goret J, Mamani-Matsuda M, Dewitte A, James C. Impaired balance between neutrophil extracellular trap formation and degradation by DNases in COVID-19 disease. J Transl Med. 2024 Mar 7;22(1):246. doi: 10.1186/s12967-024-05044-7.

    PubMed 38454482

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PubMed 34473343

  • Duvignaud A, Lhomme E, Pistone T, Onaisi R, Sitta R, Journot V, Nguyen D, Peiffer-Smadja N, Cremer A, Bouchet S, Darnaud T, Poitrenaud D, Piroth L, Binquet C, Michel JF, Lefevre B, Lebeaux D, Lebel J, Dupouy J, Roussillon C, Gimbert A, Wittkop L, Thiebaut R, Orne-Gliemann J, Joseph JP, Richert L, Anglaret X, Malvy D; COVERAGE study group. 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). Trials. 2020 Oct 13;21(1):846. doi: 10.1186/s13063-020-04619-1.

    PubMed 33050924

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vitamins, Telmisartan and Ciclesonide in people with Corona Virus Infection and Sars-CoV2, run by University Hospital, Bordeaux at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event (time frame: From inclusion (day0) to day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04356495, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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