Randomized Trial to Evaluate the Safety and Efficacy of Outpatient Treatments to Reduce the Risk of Worsening in Individuals With COVID-19 With Risk Factors (COVERAGE France)
Overview
- Phase
- Phase 2
- Intervention
- Vitamins
- Conditions
- Corona Virus Infection
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 412
- Locations
- 7
- Primary Endpoint
- Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
- •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)
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.
Arms & Interventions
Vitamins
Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
Intervention: Vitamins
Telmisartan
Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
Intervention: Telmisartan
Ciclesonide
Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days
Intervention: Ciclesonide
interferon β-1b
Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
Intervention: interferon β-1b
Outcomes
Primary Outcomes
Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event
Time Frame: From inclusion (day0) to day 14
Efficacy phase: hospitalization
Time Frame: From inclusion (day0) to day 14
Proportion of participants who had an indication for hospitalization
Efficacy phase: oxygen therapy
Time Frame: From inclusion (day0) to day 14
Proportion of participants who had an indication for oxygen therapy
Efficacy phase: Death
Time Frame: From inclusion (day0) to day 14
Proportion of participants with an occurrence of death
Secondary Outcomes
- Proportion of 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)
- Haematological markers evolution(from inclusion (day 0) to day 7)
- Proportion of intensive care hospitalizations, overall and by cause, in each group(From inclusion (day0) to day 28)
- Death and causes of death(From inclusion (day0) to day 28)
- Inflammatory markers evolution(from inclusion (day 0) to day 7)
- Adverse events(from inclusion (day 0) to day 28)
- Adverse reactions(from inclusion (day 0) to day 28)
- Acceptability of the treatment(from inclusion (day 0) to day 10)
- Oxygen saturation worsening(from inclusion (day 0) to day 28)
- Antibiotic consumption(from inclusion (day 0) to day 28)
- protocol follow-up(from inclusion (day 0) to day 10)