Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-06 @ 7:51 PM
Study NCT ID:
NCT04608266
Status:
TERMINATED
Last Update Posted:
2022-02-10
First Post:
2020-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034532', 'term': 'camostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biobanking for biomarker assessment', 'timeFrame': 'Day 1, 7, 14, 21, 90', 'description': 'Biobanking of blood samples for predictive biomarker assessment'}], 'primaryOutcomes': [{'measure': 'Hospitalization for COVID-19 deterioration or death without hospitalization', 'timeFrame': 'Day 21', 'description': 'Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Day 21', 'description': 'Number of patients with at least one adverse event'}, {'measure': 'Serious adverse events', 'timeFrame': 'Day 21', 'description': 'Number of patients with at least one serious adverse event'}, {'measure': 'Investigational medication discontinuation', 'timeFrame': 'Day 21', 'description': 'Number of patients who discontinued the investigational medication'}, {'measure': 'Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee', 'timeFrame': 'Day 21', 'description': 'Proportion of patients hospitalized for COVID-19 deterioration (reviewed by independent adjudication comitter) or who died without hospitalization'}, {'measure': 'Clinical improvement using the Word Health Organization (WHO) COVID-19 scale', 'timeFrame': 'Day 7, 14, 21', 'description': 'WHO clinical scale: Uninfected - No clinical or virological evidence of infection: 0; Ambulatory - No limitation of activities: 1; Ambulatory - limitation of activities: 2; Hospitalized - no oxygen therapy: 3; Hospitalized - oxygen by mask or nasal prongs: 4; Hospitalized; oxygen by non invasive ventilation or High flow: 5; Intubation and Mechanical ventilation: 6; Mechanical ventilation + additional organ support (pressors, Renal replacement therapy, ECMO):7; Dead: 8'}, {'measure': 'Need for intensive care', 'timeFrame': 'Day 21', 'description': 'Proportion of patients admitted to an intensive care unit'}, {'measure': 'Duration of hospitalization', 'timeFrame': 'Day 21', 'description': 'Number of days alive without hospitalization up to day 21'}, {'measure': 'Need for invasive mechanical ventilation for severe COVID-19', 'timeFrame': 'Day 21', 'description': 'Proportion of patients with initiation of invasive mechanical ventilation'}, {'measure': 'Need for oxygen therapy for COVID-19', 'timeFrame': 'Day 21', 'description': 'Proportion of patients with initiation of oxygen therapy'}, {'measure': 'Overall survival', 'timeFrame': 'Day 90', 'description': 'Proportion of patients alive at day 90'}, {'measure': 'Duration of symptoms', 'timeFrame': 'Day 21', 'description': 'Number of days alive without symptoms at day 21'}, {'measure': 'SARS-CoV-2 virological assessment', 'timeFrame': 'Day 7, 14, 21', 'description': 'By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) on nasal swab and droplet quantification of SARS-CoV2 ribonucleic acid-emia (RNAemia)'}, {'measure': 'SARS-CoV-2 serological assessment', 'timeFrame': 'Day 7, 14, 21 and 90', 'description': 'SARS-CoV2 antibodies quantification in blood'}, {'measure': 'Peripheral blood lymphocyte phenotyping', 'timeFrame': 'Day 1, 14, 90', 'description': 'Peripheral blood lymphocyte phenotyping with telomere length measurement'}, {'measure': 'Acute kidney failure', 'timeFrame': 'Day 21', 'description': 'Acute kidney failure defined as at least serum creatinine increase of 0.3mg/dl or 1.5-1.9 times baseline and/or oliguria \\< 0.5ml/kg/h'}, {'measure': 'Renal function', 'timeFrame': 'Day 7, 14 and 21', 'description': 'estimated glomerular filtration rate'}, {'measure': 'Concentration of urea in blood', 'timeFrame': 'Day 7, 14 and 21', 'description': 'Uricemia in mmol/L or mg/dL'}, {'measure': 'Concentration of potassium in blood', 'timeFrame': 'Day 7, 14 and 21', 'description': 'Kaliemia in mmol/L'}, {'measure': 'Liver function', 'timeFrame': 'Day 7, 14 and 21', 'description': 'Liver transaminases dosage on blood sample'}, {'measure': 'Liver function (2)', 'timeFrame': 'Day 7, 14 and 21', 'description': 'Gamma-glutamyl transferase (gamma-GT) dosage on blood sample'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines.\n\nCamostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Patients with an increased risk of severe COVID-19 belonging to one or more of the following groups :\n\n * Age ≥ 50 years\n * Body Mass Index ≥ 30 kg/m²\n * Diabetes\n * Hypertension\n * Chronic renal failure (eGFR \\<60 mL/min)\n * Chronic heart disease\n * Asthma/Chronic Obstructive Pumonary Disease/Cystic fibrosis\n * Chronic liver disease\n * Chronic neurological disease\n * Solid organ transplant\n * Bone marrow transplant\n * Sickle cell anemia/ Major thalassemias\n * Active or currently treated or \\<1 year diagnosed cancer\n * Active or currently treated or \\<1 year diagnosed malignant blood disease\n * Immunosuppressive treatment observed for more than 1 month\n* Laboratory confirmed SARS-CoV2 infection with mild COVID-19, fulfilling all the following criteria:\n\n * Positive SARS-CoV-2 RT-PCR nasal swab samples AND\n * Clinical symptoms and signs consistent with SARS-CoV2 infection including but not limited to, fever, upper respiratory tract infection signs, digestive signs, muscle pain, anosmia, dysgueusia…(1)\n* Informed consent to participate to the trial\n* Patients must be able and willing to comply with study visits and procedures\n\nExclusion Criteria:\n\n* Initial need for hospitalization for COVID-19 management\n* Pregnancy and breastfeeding\n* Participation to another interventional drug trial\n* Subject protected by law under guardianship or curatorship\n* Absence of health insurance\n* Known hypersensitivity to camostat mesylate\n* Known person sharing the same household already included in the study\n* Participation to another COVID-19 ambulatory interventional study\n* Patients having completed a full SARS-CoV2 vaccine immunization procedure less than 4 weeks prior to COVID-19 diagnosis (last vaccine injection performed less than 4 weeks prior to COVID-19 diagnosis)'}, 'identificationModule': {'nctId': 'NCT04608266', 'acronym': 'CAMOVID', 'briefTitle': 'CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID)', 'orgStudyIdInfo': {'id': 'APHP200702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Camostat mesylate', 'description': 'Camostat mesylate, oral administration 600mg/day', 'interventionNames': ['Drug: Camostat Mesylate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets, oral administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Camostat Mesylate', 'type': 'DRUG', 'description': 'Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days', 'armGroupLabels': ['Camostat mesylate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets, oral administration 2 tablets every 8 hours for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Argenteuil', 'country': 'France', 'facility': 'Centre Hospitalier Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Créteil', 'country': 'France', 'facility': 'AP-HP Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Melun', 'country': 'France', 'facility': 'Centre Hospitalier Sud Ile de France - Melun', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP - Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Centre de Santé Richerand', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}