Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 11:13 AM
Study NCT ID:
NCT04390594
Status:
TERMINATED
Last Update Posted:
2024-06-21
First Post:
2020-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal
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': 'C032855', 'term': 'nafamostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'whyStopped': 'In conclusion, the results of the SEN-CoV Fadj trial to date do not meet the objectives of the clinical trial and the sample size required to meet them is clearly too large to be achieved within a reasonable time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 viral load level', 'timeFrame': 'Day 7', 'description': 'Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample'}], 'secondaryOutcomes': [{'measure': 'Vital status', 'timeFrame': 'Day 15'}, {'measure': 'Proportion of patients with serious adverse events reported during the clinical trial.', 'timeFrame': 'through study completion, an average of 7 months'}, {'measure': 'Length of hospitalization', 'timeFrame': 'through hospitalization, an average of 2 weeks'}, {'measure': 'Length of hospitalization in a resuscitation unit', 'timeFrame': 'through hospitalization, an average of 2 weeks'}, {'measure': 'Duration of oxygen therapy', 'timeFrame': 'through hospitalization, an average of 2 weeks'}, {'measure': 'Maximum quick SOFA (qSOFA) score during hospitalisation', 'timeFrame': 'through hospitalization, an average of 2 weeks'}, {'measure': 'Clinical status on the seven-category ordinal scale', 'timeFrame': 'through hospitalization, an average of 2 weeks', 'description': '1. not hospitalized with resumption of normal activities;\n2. not hospitalized, but unable to resume normal activities;\n3. hospitalization, not requiring supplemental oxygen;\n4. hospitalization, requiring supplemental oxygen;\n5. hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;\n6. hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;\n7. death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'Efficacy', 'Safety', 'Senegal', 'Nafamostat mesilate'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019. A rapid spread of the disease has occurred at a global scale, associated with a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt and the first case in Senegal was declared on March 2nd, 2020.\n\nIn this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and safety, among adults, of different therapeutic regimens considered optimal according to current knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological, virologic and immunological characteristics of the infection. The protocol of the cohort is based and adapted from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol (CCP).\n\nThe Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe COVID-19 cases.', 'detailedDescription': 'COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019. A rapid spread of the disease has occurred at a global scale, associated with a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt and the first case in Senegal was declared on March 2nd, 2020.\n\nIn this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and tolerance, among adults, of different therapeutic options considered optimal according to current knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological, virologic and immunological characteristics of the infection. The protocol of the cohort is based and adapted from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol (CCP).\n\nThe Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe COVID-19 cases. Its efficacy and safety will be evaluated against the standard of care used in Senegal.\n\nThe primary objective is to :\n\nEvaluate and compare viral clearance between the different therapeutic interventions.\n\nThe secondary objectives are to:\n\n* Evaluate and compare efficacy of the different therapeutic regimens\n* Evaluate and compare the tolerance of the different therapeutic regimens\n* Evaluate and compare the impact of the different therapeutic interventions on the length of hospitalization and other clinical measurements'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed cases of SARS-CoV-2 infection hospitalized in reference services identified by the Ministry of Health and Social Action of Senegal\n* Adults (≥18 years)\n* Full understanding and consent to participate to the trial\n* No contraindications to taking the tested treatments\n* Clinical status from 3 to 5 on the seven-category ordinal scale\n* Pneumonia highlighted by infiltration of the lungs by chest CT scan or chest radiography\n* Absence of contraindications to radiographic examinations (X-ray and/or CT scan) for diagnosis and/or follow-up\n* Inclusion in the 72 hours following the radiological pneumonia confirmation\n\nNon-inclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Patient at high risk of death within 3 days of inclusion, in the clinician's opinion\n* Corrected QT interval (QTc) \\>500ms\n* Heart electrical dysfunction: atrioventricular block Mobitz type II second-degree, high-grade or complete without a functioning pacemaker\n* Uncontrolled and clinically significant heart diseases, such as arrhythmia, angina or decompensated congestive heart failure\n* Kidney failure (Cl \\< 30 mL/min)\n* Patients with liver cirrhosis whose Child-Puch score is B or C\n* Patients who have liver disease abnormalities with ALT or AST \\> 5 times ULN\n* Patients who have a known HIV status\n* Patients who have other clinically-important diseases in decompensation which may interfere with the evaluation or completion of the tested treatment's procedure, in the clinician's opinion\n* Patients with a clinical or psychological condition which, in the clinician's opinion, does not allow adequate evaluation of the tested treatment\n* Known allergy to the studied treatment regimen\n* Other contraindications with the studied treatment regimen\n* Known drug-drug interaction with a treatment usually taken by the participant contraindicating one of the studied treatment regimen"}, 'identificationModule': {'nctId': 'NCT04390594', 'acronym': 'SEN-CoV-Fadj', 'briefTitle': 'Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal', 'organization': {'class': 'OTHER', 'fullName': 'Institut Pasteur de Dakar'}, 'officialTitle': 'Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal', 'orgStudyIdInfo': {'id': '2020-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': "The Standard of Care is the treatment which is the most adapted to the patient in the clinician's opinion. It could include the combination of Hydroxychloroquine and Azithromycin in the absence of contraindication."}, {'type': 'EXPERIMENTAL', 'label': 'Standard of Care + Nafamostat mesilate', 'description': "* The Standard of Care is the treatment which is the most adapted to the patient in the clinician's opinion. It could include the combination of Hydroxychloroquine and Azithromycin in the absence of contraindication.\n* Nafamostat mesilate", 'interventionNames': ['Drug: Nafamostat Mesilate']}], 'interventions': [{'name': 'Nafamostat Mesilate', 'type': 'DRUG', 'description': 'Nafamostat mesilate continuous intravenous injection. Daily dose ranging between 0.1 mg/kg/h and 0.2 mg/kg/h, based on the severity and underlying disease of the clinical trial participant.\n\nAdministration for 10-14 days based on the severity and underlying disease of the clinical trial participant', 'armGroupLabels': ['Standard of Care + Nafamostat mesilate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dakar', 'country': 'Senegal', 'facility': 'Infectious and Tropical Diseases Department, Fann Hospital', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}, {'city': 'Diamniadio', 'country': 'Senegal', 'facility': 'Diamniadio Children Hospital', 'geoPoint': {'lat': 14.72051, 'lon': -17.1816}}, {'city': 'Guédiawaye', 'country': 'Senegal', 'facility': 'Dalal Jamm Hospital', 'geoPoint': {'lat': 14.77446, 'lon': -17.40212}}], 'overallOfficials': [{'name': 'Moussa Seydi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fann Hospital, Senegal'}, {'name': 'Amadou A. Sall, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Pasteur de Dakar, Senegal'}, {'name': 'Fabien Taieb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur de Dakar, Senegal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur de Dakar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fann Hospital, Senegal', 'class': 'UNKNOWN'}, {'name': 'Ministry of Health, Senegal', 'class': 'OTHER_GOV'}, {'name': 'Diamniadio Children Hospital, Senegal', 'class': 'UNKNOWN'}, {'name': 'Dalal Jamm Hospital, Senegal', 'class': 'OTHER'}, {'name': 'Institut Pasteur Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}