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.
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.
Dietary Supplement: Vitamins
2 tablets daily from the first day (day 0) to day 9
Drug: Telmisartan
1 tablet daily from the first day (day 0) to day 9
Drug: Ciclesonide
2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
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
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.
Bordeaux university Hospital
Bordeaux, France
CHU de Dijon-Bourgogne
Dijon, France
CHU de Montpellier
Montpellier, France
CHRU de Nancy
Nancy, France
Groupe hospitalier Paris Saint Joseph
Paris, France
CNGE
Paris, France
CHU de Toulouse
Toulouse, France