Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
NCT ID: NCT04356495
Last Updated: 2022-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
412 participants
INTERVENTIONAL
2020-07-29
2021-10-22
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
NONE
Study Groups
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Vitamins
Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
Vitamins
2 tablets daily from the first day (day 0) to day 9
Telmisartan
Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
Telmisartan
1 tablet daily from the first day (day 0) to day 9
Ciclesonide
Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days
Ciclesonide
2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
interferon β-1b
Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
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
Interventions
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Vitamins
2 tablets daily from the first day (day 0) to day 9
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 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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University of Bordeaux
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Denis MALVY, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Xavier ANGLARET, Dr
Role: STUDY_DIRECTOR
Inserm 1219
Laura RICHERT, Dr
Role: STUDY_CHAIR
University Hospital, Bordeaux
Locations
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Bordeaux university Hospital
Bordeaux, , France
CHU de Dijon-Bourgogne
Dijon, , France
CHU de Montpellier
Montpellier, , France
CHRU de Nancy
Nancy, , France
Groupe hospitalier Paris Saint Joseph
Paris, , France
CNGE
Paris, , France
CHU de Toulouse
Toulouse, , France
Countries
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References
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Garcia G, Labrouche-Colomer S, Duvignaud A, Clequin E, Dussiau C, Tregouet DA, Malvy D, Prevel R, Zouine A, Pellegrin I, Goret J, Mamani-Matsuda M, Dewitte A, James C. Impaired balance between neutrophil extracellular trap formation and degradation by DNases in COVID-19 disease. J Transl Med. 2024 Mar 7;22(1):246. doi: 10.1186/s12967-024-05044-7.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Duvignaud A, Lhomme E, Pistone T, Onaisi R, Sitta R, Journot V, Nguyen D, Peiffer-Smadja N, Cremer A, Bouchet S, Darnaud T, Poitrenaud D, Piroth L, Binquet C, Michel JF, Lefevre B, Lebeaux D, Lebel J, Dupouy J, Roussillon C, Gimbert A, Wittkop L, Thiebaut R, Orne-Gliemann J, Joseph JP, Richert L, Anglaret X, Malvy D; COVERAGE study group. Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial). Trials. 2020 Oct 13;21(1):846. doi: 10.1186/s13063-020-04619-1.
Other Identifiers
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CHUBX 2020/12
Identifier Type: -
Identifier Source: org_study_id
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