Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT04356495
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04356495
Study Brief:
Protocol Section:
NCT04356495