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

University Hospital of Bordeaux

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sars-CoV2; Corona Virus Infection

Treatments: Dietary Supplement: Vitamins; Drug: Telmisartan; Drug: interferon β-1b; Drug: Ciclesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT04356495

CHUBX 2020/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 412 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

• 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 :

    • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

412 participants in 4 patient groups

Vitamins

Sham Comparator group

Description:

Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days

Treatment:

Dietary Supplement: Vitamins

Telmisartan

Experimental group

Description:

Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days

Treatment:

Drug: Telmisartan

Ciclesonide

Experimental group

Description:

Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days

Treatment:

Drug: Ciclesonide

interferon β-1b

Experimental group

Description:

Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days

Treatment:

Drug: interferon β-1b