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

Corona Virus Infection Clinical Trial

— COVERAGEFrance  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356495
• Other study ID #: CHUBX 2020/12
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 29, 2020
• Est. completion date: October 22, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: October 22, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Sars-CoV2

Intervention

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
• Ciclesonide
2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
• interferon ß-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-ß-1b (EXTAVIA®) diluted in 2 mL of water

Locations

Country	Name	City	State
France	Bordeaux university Hospital	Bordeaux
France	CHU de Dijon-Bourgogne	Dijon
France	CHU de Montpellier	Montpellier
France	CHRU de Nancy	Nancy
France	CNGE	Paris
France	Groupe hospitalier Paris Saint Joseph	Paris
France	CHU de Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event		From inclusion (day0) to day 14
Primary	Efficacy phase: Death	Proportion of participants with an occurrence of death	From inclusion (day0) to day 14
Primary	Efficacy phase: oxygen therapy	Proportion of participants who had an indication for oxygen therapy	From inclusion (day0) to day 14
Primary	Efficacy phase: hospitalization	Proportion of participants who had an indication for hospitalization	From inclusion (day0) to day 14
Secondary	Proportion of hospitalizations, overall and by cause, in each group		From inclusion (day0) to day 28
Secondary	Death and causes of death	Proportion of deaths, overall and by cause, in each group	From inclusion (day0) to day 28
Secondary	Proportion of intensive care hospitalizations, overall and by cause, in each group		From inclusion (day0) to day 28
Secondary	Proportion of participants with negative SARS-CoV-2 RT-PCR		day 7
Secondary	Haematological markers evolution	Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR	from inclusion (day 0) to day 7
Secondary	Inflammatory markers evolution	Evolution of Inflammatory markers in each group : PCT, CRP	from inclusion (day 0) to day 7
Secondary	Adverse events	Number and proportion of grade 1,2,3,4 adverse events in each group	from inclusion (day 0) to day 28
Secondary	Adverse reactions	Number and proportion of grade 1,2,3,4 adverse events in each group	from inclusion (day 0) to day 28
Secondary	Acceptability of the treatment	Acceptability of the treatment by participant will be assessed with an interview	from inclusion (day 0) to day 10
Secondary	Antibiotic consumption	Proportion of participants who received at least one day of antibiotic therapy	from inclusion (day 0) to day 28
Secondary	Oxygen saturation worsening	Proportion of participants who experienced a worsening of oxygen saturation	from inclusion (day 0) to day 28
Secondary	protocol follow-up	Proportion of participants who completed the prescribed protocol treatment	from inclusion (day 0) to day 10