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

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ClinicalTrials.gov Identifier: NCT04356495
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
University of Bordeaux
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 820 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.
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 : July 29, 2020
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event [ Time Frame: From inclusion (day0) to day 14 ]
  2. Efficacy phase: Death [ Time Frame: From inclusion (day0) to day 14 ]
    Proportion of participants with an occurrence of death

  3. Efficacy phase: oxygen therapy [ Time Frame: From inclusion (day0) to day 14 ]
    Proportion of participants who had an indication for oxygen therapy

  4. Efficacy phase: hospitalization [ Time Frame: From inclusion (day0) to day 14 ]
    Proportion of participants who had an indication for hospitalization


Secondary Outcome Measures :
  1. Proportion of hospitalizations, overall and by cause, in each group [ Time Frame: From inclusion (day0) to day 28 ]
  2. Death and causes of death [ Time Frame: From inclusion (day0) to day 28 ]
    Proportion of deaths, overall and by cause, in each group

  3. Proportion of intensive care hospitalizations, overall and by cause, in each group [ Time Frame: From inclusion (day0) to day 28 ]
  4. Proportion of participants with negative SARS-CoV-2 RT-PCR [ Time Frame: day 7 ]
  5. Haematological markers evolution [ Time Frame: from inclusion (day 0) to day 7 ]
    Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR

  6. Inflammatory markers evolution [ Time Frame: from inclusion (day 0) to day 7 ]
    Evolution of Inflammatory markers in each group : PCT, CRP

  7. Adverse events [ Time Frame: from inclusion (day 0) to day 28 ]
    Number and proportion of grade 1,2,3,4 adverse events in each group

  8. Adverse reactions [ Time Frame: from inclusion (day 0) to day 28 ]
    Number and proportion of grade 1,2,3,4 adverse events in each group

  9. Acceptability of the treatment [ Time Frame: from inclusion (day 0) to day 10 ]
    Acceptability of the treatment by participant will be assessed with an interview

  10. Antibiotic consumption [ Time Frame: from inclusion (day 0) to day 28 ]
    Proportion of participants who received at least one day of antibiotic therapy

  11. Oxygen saturation worsening [ Time Frame: from inclusion (day 0) to day 28 ]
    Proportion of participants who experienced a worsening of oxygen saturation

  12. protocol follow-up [ Time Frame: from inclusion (day 0) to day 10 ]
    Proportion of participants who completed the prescribed protocol treatment


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356495


Contacts
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Contact: Denis MALVY, Pr 0557822796 ext +33 denis.malvy@chu-bordeaux.fr
Contact: Xavier ANGLARET, Dr 0557571258 ext +33 xavier.anglaret@u-bordeaux.fr

Locations
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France
CH de Bastia Recruiting
Bastia, France
Contact: Thomas DARNAUD, Dr       thomas.darnaud@ch-bastia.fr   
Bordeaux university Hospital Recruiting
Bordeaux, France, 33000
Contact: Alexandre DUVIGNAUD, Dr       alexandre.duvignaud@chu-bordeaux.fr   
Contact: Xavier ANGLARET, Dr    0557571258 ext +33    xavier.anglaret@u-bordeaux.fr   
CHU de Dijon-Bourgogne Recruiting
Dijon, France
Contact: Lionel PIROTH, Pr       lionel.piroth@chu-dijon.fr   
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Alain MAKINSON, Dr       a-makinson@chu-montpellier.fr   
CHRU de Nancy Recruiting
Nancy, France
Contact: Benjamin LEFEVRE, Dr       B.LEFEVRE@chru-nancy.fr   
Groupe hospitalier Paris Saint Joseph Not yet recruiting
Paris, France, 75014
Contact: Jean-Marc NACCACHE, Dr       jmnaccache@ghpsj.fr   
IMEA Not yet recruiting
Paris, France, 75018
Contact: Roland LANDMAN, Dr       landman.roland@gmail.com   
CHU de Toulouse Recruiting
Toulouse, France
Contact: Julie DUPOUY, Dr       julie.dupouy@dumg-toulouse.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
University of Bordeaux
Investigators
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Principal Investigator: Denis MALVY, Pr University Hospital, Bordeaux
Study Director: Xavier ANGLARET, Dr Inserm 1219
Study Chair: Laura RICHERT, Dr University Hospital, Bordeaux
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04356495    
Other Study ID Numbers: CHUBX 2020/12
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Corona virus
Sars-CoV2
telmisartan
ciclesonide
interferon β-1b
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Ciclesonide
Interferons
Interferon-beta
Telmisartan
Interferon beta-1b
Physiological Effects of Drugs
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents
Immunologic Factors
Adjuvants, Immunologic