Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 4:58 AM
Study NCT ID:
NCT04356495
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2020-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014815', 'term': 'Vitamins'}, {'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'C120481', 'term': 'ciclesonide'}], 'ancestors': [{'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, randomized, controlled clinical trial with for each drug :\n\n* A safety study pilot phase.\n* 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 412}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2020-04-11', 'studyFirstSubmitQcDate': '2020-04-19', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event', 'timeFrame': 'From inclusion (day0) to day 14'}, {'measure': 'Efficacy phase: Death', 'timeFrame': 'From inclusion (day0) to day 14', 'description': 'Proportion of participants with an occurrence of death'}, {'measure': 'Efficacy phase: oxygen therapy', 'timeFrame': 'From inclusion (day0) to day 14', 'description': 'Proportion of participants who had an indication for oxygen therapy'}, {'measure': 'Efficacy phase: hospitalization', 'timeFrame': 'From inclusion (day0) to day 14', 'description': 'Proportion of participants who had an indication for hospitalization'}], 'secondaryOutcomes': [{'measure': 'Proportion of hospitalizations, overall and by cause, in each group', 'timeFrame': 'From inclusion (day0) to day 28'}, {'measure': 'Death and causes of death', 'timeFrame': 'From inclusion (day0) to day 28', 'description': 'Proportion of deaths, overall and by cause, in each group'}, {'measure': 'Proportion of intensive care hospitalizations, overall and by cause, in each group', 'timeFrame': 'From inclusion (day0) to day 28'}, {'measure': 'Proportion of participants with negative SARS-CoV-2 RT-PCR', 'timeFrame': 'day 7'}, {'measure': 'Haematological markers evolution', 'timeFrame': 'from inclusion (day 0) to day 7', 'description': 'Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR'}, {'measure': 'Inflammatory markers evolution', 'timeFrame': 'from inclusion (day 0) to day 7', 'description': 'Evolution of Inflammatory markers in each group : PCT, CRP'}, {'measure': 'Adverse events', 'timeFrame': 'from inclusion (day 0) to day 28', 'description': 'Number and proportion of grade 1,2,3,4 adverse events in each group'}, {'measure': 'Adverse reactions', 'timeFrame': 'from inclusion (day 0) to day 28', 'description': 'Number and proportion of grade 1,2,3,4 adverse events in each group'}, {'measure': 'Acceptability of the treatment', 'timeFrame': 'from inclusion (day 0) to day 10', 'description': 'Acceptability of the treatment by participant will be assessed with an interview'}, {'measure': 'Antibiotic consumption', 'timeFrame': 'from inclusion (day 0) to day 28', 'description': 'Proportion of participants who received at least one day of antibiotic therapy'}, {'measure': 'Oxygen saturation worsening', 'timeFrame': 'from inclusion (day 0) to day 28', 'description': 'Proportion of participants who experienced a worsening of oxygen saturation'}, {'measure': 'protocol follow-up', 'timeFrame': 'from inclusion (day 0) to day 10', 'description': 'Proportion of participants who completed the prescribed protocol treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corona virus', 'Sars-CoV2', 'telmisartan', 'ciclesonide', 'interferon β-1b'], 'conditions': ['Corona Virus Infection', 'Sars-CoV2']}, 'referencesModule': {'references': [{'pmid': '38454482', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33050924', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'COVERAGE France is Multicenter, randomized, controlled clinical trial with for each drug :\n\n* A safety study pilot phase.\n* 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.\n* 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.\n* 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.\n\nThe trial is a national platform with the vocation to open as many centers as possible, subject to criteria set by the Scientific Advisory Board.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical picture suggestive of COVID-19 dated 7 days or less.\n* Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.\n* Absence of criteria for hospitalization or oxygen therapy according to current recommendations.\n* Age :\n\n * greater than or equal to 60 years of age without any risk factor\n * or between 50 and 59 years of age and the presence of at least one of the following risk factors :\n\n * Arterial hypertension under treatment (all stages)\n * Obesity (BMI ≥30 kg/m2)\n * Diabetes under treatment (all types)\n * Ischemic heart disease (all stages)\n * Heart failure (all stages)\n * Stroke History\n * Chronic Obstructive Pulmonary Disease (all stages)\n * Stage 3 chronic renal failure (30 ≤ Estimated GFR \\< 60 mL/min/1.73 m²)\n * Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.\n * Immunodeficiency\n* 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);\n* HIV infection with CD4\\<200/mm3.\n* Valid, ambulatory person, fully able to understand the issues of the trial\n* Beneficiary of a Social Security scheme\n* Signed informed consent\n\nExclusion Criteria:\n\n* Asymptomatic person\n* Inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship)\n* Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.'}, 'identificationModule': {'nctId': 'NCT04356495', 'acronym': 'COVERAGEFrance', 'briefTitle': 'Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CHUBX 2020/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Vitamins', 'description': 'Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days', 'interventionNames': ['Dietary Supplement: Vitamins']}, {'type': 'EXPERIMENTAL', 'label': 'Telmisartan', 'description': 'Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days', 'interventionNames': ['Drug: Telmisartan']}, {'type': 'EXPERIMENTAL', 'label': 'Ciclesonide', 'description': 'Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days', 'interventionNames': ['Drug: Ciclesonide']}, {'type': 'EXPERIMENTAL', 'label': 'interferon β-1b', 'description': 'Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days', 'interventionNames': ['Drug: interferon β-1b']}], 'interventions': [{'name': 'Vitamins', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 tablets daily from the first day (day 0) to day 9', 'armGroupLabels': ['Vitamins']}, {'name': 'Telmisartan', 'type': 'DRUG', 'description': '1 tablet daily from the first day (day 0) to day 9', 'armGroupLabels': ['Telmisartan']}, {'name': 'Ciclesonide', 'type': 'DRUG', 'description': '2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9', 'armGroupLabels': ['Ciclesonide']}, {'name': 'interferon β-1b', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['interferon β-1b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux university Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon-Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'CNGE', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Denis MALVY, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Xavier ANGLARET, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inserm 1219'}, {'name': 'Laura RICHERT, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bordeaux', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}