Corona Virus Infection, Sars-CoV2
Conditions
Keywords
Corona virus, Sars-CoV2, telmisartan, ciclesonide, interferon β-1b
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. No treatment is currently validated for this indication.
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 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.
Interventions
DIETARY_SUPPLEMENTVitamins
2 tablets daily from the first day (day 0) to day 9
DRUGTelmisartan
1 tablet daily from the first day (day 0) to day 9
DRUGCiclesonide
2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
DRUGinterferon 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
Sponsors
University of Bordeaux
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event | From inclusion (day0) to day 14 | — |
| Efficacy phase: Death | From inclusion (day0) to day 14 | Proportion of participants with an occurrence of death |
| Efficacy phase: oxygen therapy | From inclusion (day0) to day 14 | Proportion of participants who had an indication for oxygen therapy |
| Efficacy phase: hospitalization | From inclusion (day0) to day 14 | Proportion of participants who had an indication for hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haematological markers evolution | from inclusion (day 0) to day 7 | Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR |
| Inflammatory markers evolution | from inclusion (day 0) to day 7 | Evolution of Inflammatory markers in each group : PCT, CRP |
| Adverse events | from inclusion (day 0) to day 28 | Number and proportion of grade 1,2,3,4 adverse events in each group |
| Adverse reactions | from inclusion (day 0) to day 28 | Number and proportion of grade 1,2,3,4 adverse events in each group |
| Proportion of hospitalizations, overall and by cause, in each group | From inclusion (day0) to day 28 | — |
| Antibiotic consumption | from inclusion (day 0) to day 28 | Proportion of participants who received at least one day of antibiotic therapy |
| Oxygen saturation worsening | from inclusion (day 0) to day 28 | Proportion of participants who experienced a worsening of oxygen saturation |
| protocol follow-up | from inclusion (day 0) to day 10 | Proportion of participants who completed the prescribed protocol treatment |
| Acceptability of the treatment | from inclusion (day 0) to day 10 | Acceptability of the treatment by participant will be assessed with an interview |
| Death and causes of death | From inclusion (day0) to day 28 | Proportion of deaths, overall and by cause, in each group |
| Proportion of intensive care hospitalizations, overall and by cause, in each group | From inclusion (day0) to day 28 | — |
| Proportion of participants with negative SARS-CoV-2 RT-PCR | day 7 | — |
Countries
France
Outcome results
None listed