Status:
COMPLETED
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
University of Bordeaux
Conditions:
Corona Virus Infection
Sars-CoV2
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief 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....
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2021
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT04356495
Start Date
July 29 2020
End Date
October 22 2021
Last Update
February 4 2022
Active Locations (7)
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1
Bordeaux university Hospital
Bordeaux, France, 33000
2
CHU de Dijon-Bourgogne
Dijon, France
3
CHU de Montpellier
Montpellier, France, 34295
4
CHRU de Nancy
Nancy, France