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

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.

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.