Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation (COVERAGEFrance)
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ClinicalTrials.gov Identifier: NCT04356495 |
Recruitment Status :
Recruiting
First Posted : April 22, 2020
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Corona Virus Infection Sars-CoV2 | Dietary Supplement: Vitamins Drug: Telmisartan Drug: Ciclesonide Drug: interferon β-1b | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 820 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Multicenter, randomized, controlled clinical trial with for each drug :
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Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | July 29, 2020 |
Estimated Primary Completion Date : | August 15, 2021 |
Estimated Study Completion Date : | August 31, 2021 |

Arm | Intervention/treatment |
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Sham Comparator: Vitamins
Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
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Dietary Supplement: Vitamins
2 tablets daily from the first day (day 0) to day 9 |
Experimental: Telmisartan
Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
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Drug: Telmisartan
1 tablet daily from the first day (day 0) to day 9 |
Experimental: Ciclesonide
Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days
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Drug: Ciclesonide
2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9 |
Experimental: interferon β-1b
Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
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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 |
- Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event [ Time Frame: From inclusion (day0) to day 14 ]
- Efficacy phase: Death [ Time Frame: From inclusion (day0) to day 14 ]Proportion of participants with an occurrence of death
- Efficacy phase: oxygen therapy [ Time Frame: From inclusion (day0) to day 14 ]Proportion of participants who had an indication for oxygen therapy
- Efficacy phase: hospitalization [ Time Frame: From inclusion (day0) to day 14 ]Proportion of participants who had an indication for hospitalization
- Proportion of hospitalizations, overall and by cause, in each group [ Time Frame: From inclusion (day0) to day 28 ]
- Death and causes of death [ Time Frame: From inclusion (day0) to day 28 ]Proportion of deaths, overall and by cause, in each group
- Proportion of intensive care hospitalizations, overall and by cause, in each group [ Time Frame: From inclusion (day0) to day 28 ]
- Proportion of participants with negative SARS-CoV-2 RT-PCR [ Time Frame: day 7 ]
- Haematological markers evolution [ Time Frame: from inclusion (day 0) to day 7 ]Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR
- Inflammatory markers evolution [ Time Frame: from inclusion (day 0) to day 7 ]Evolution of Inflammatory markers in each group : PCT, CRP
- Adverse events [ Time Frame: from inclusion (day 0) to day 28 ]Number and proportion of grade 1,2,3,4 adverse events in each group
- Adverse reactions [ Time Frame: from inclusion (day 0) to day 28 ]Number and proportion of grade 1,2,3,4 adverse events in each group
- Acceptability of the treatment [ Time Frame: from inclusion (day 0) to day 10 ]Acceptability of the treatment by participant will be assessed with an interview
- Antibiotic consumption [ Time Frame: from inclusion (day 0) to day 28 ]Proportion of participants who received at least one day of antibiotic therapy
- Oxygen saturation worsening [ Time Frame: from inclusion (day 0) to day 28 ]Proportion of participants who experienced a worsening of oxygen saturation
- protocol follow-up [ Time Frame: from inclusion (day 0) to day 10 ]Proportion of participants who completed the prescribed protocol treatment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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Age :
- greater than or equal to 60 years of age without any risk factor
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or between 50 and 59 years of age and the presence of at least one of the following risk factors :
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356495
Contact: Denis MALVY, Pr | 0557822796 ext +33 | denis.malvy@chu-bordeaux.fr | |
Contact: Xavier ANGLARET, Dr | 0557571258 ext +33 | xavier.anglaret@u-bordeaux.fr |
France | |
CH de Bastia | Recruiting |
Bastia, France | |
Contact: Thomas DARNAUD, Dr thomas.darnaud@ch-bastia.fr | |
Bordeaux university Hospital | Recruiting |
Bordeaux, France, 33000 | |
Contact: Alexandre DUVIGNAUD, Dr alexandre.duvignaud@chu-bordeaux.fr | |
Contact: Xavier ANGLARET, Dr 0557571258 ext +33 xavier.anglaret@u-bordeaux.fr | |
CHU de Dijon-Bourgogne | Recruiting |
Dijon, France | |
Contact: Lionel PIROTH, Pr lionel.piroth@chu-dijon.fr | |
CHU de Montpellier | Recruiting |
Montpellier, France, 34295 | |
Contact: Alain MAKINSON, Dr a-makinson@chu-montpellier.fr | |
CHRU de Nancy | Recruiting |
Nancy, France | |
Contact: Benjamin LEFEVRE, Dr B.LEFEVRE@chru-nancy.fr | |
Groupe hospitalier Paris Saint Joseph | Not yet recruiting |
Paris, France, 75014 | |
Contact: Jean-Marc NACCACHE, Dr jmnaccache@ghpsj.fr | |
IMEA | Not yet recruiting |
Paris, France, 75018 | |
Contact: Roland LANDMAN, Dr landman.roland@gmail.com | |
CHU de Toulouse | Recruiting |
Toulouse, France | |
Contact: Julie DUPOUY, Dr julie.dupouy@dumg-toulouse.fr |
Principal Investigator: | Denis MALVY, Pr | University Hospital, Bordeaux | |
Study Director: | Xavier ANGLARET, Dr | Inserm 1219 | |
Study Chair: | Laura RICHERT, Dr | University Hospital, Bordeaux |
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT04356495 |
Other Study ID Numbers: |
CHUBX 2020/12 |
First Posted: | April 22, 2020 Key Record Dates |
Last Update Posted: | January 22, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Corona virus Sars-CoV2 telmisartan ciclesonide interferon β-1b |
Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Infections Respiratory Tract Diseases Ciclesonide Interferons Interferon-beta Telmisartan Interferon beta-1b Physiological Effects of Drugs |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Allergic Agents Immunologic Factors Adjuvants, Immunologic |