COVERAGEFrance: Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT04356495

Collaborator

University of Bordeaux (Other)

412

Enrollment

Locations

Arms

14.8

Actual Duration (Months)

58.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection Sars-CoV2	Dietary Supplement: Vitamins Drug: Telmisartan Drug: Ciclesonide Drug: interferon β-1b	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

412 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jul 29, 2020

Actual Primary Completion Date :

Oct 8, 2021

Actual Study Completion Date :

Oct 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Vitamins Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days	Dietary Supplement: Vitamins 2 tablets daily from the first day (day 0) to day 9
Experimental: Telmisartan Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days	Drug: Telmisartan 1 tablet daily from the first day (day 0) to day 9
Experimental: Ciclesonide Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days	Drug: Ciclesonide 2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
Experimental: interferon β-1b Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Proportion of 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]
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]
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
Acceptability of the treatment [from inclusion (day 0) to day 10]
Acceptability of the treatment by participant will be assessed with an interview
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	Groupe hospitalier Paris Saint Joseph	Paris	France	75014
6	CNGE	Paris	France
7	CHU de Toulouse	Toulouse	France