Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05249751
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Copeptin in COVID-19
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The role of Copeptin in severity stratification of CoVID-19', 'timeFrame': 'By the end of the study (September 2021)', 'description': "to determine the effect of COVID-19 severity on the serum copeptin level, which serves as a stress indicator for infection-related complications. Additionally, to link this effect with that of COVID-19's other inflammatory biomarkers, including C-reactive protein (CRP), ferritin, and D-dimer. Additionally, to investigate its utility as a differentiating factor amongst COVID-19 severity classes."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the change in serum level of copeptin, a neuroendocrine biomarker, in differentiation between mild-moderate and severe COVID-19 cases on admission time and to find its diagnostic potential.', 'detailedDescription': "This prospective study enrolled 160 individuals with confirmed COVID-19 infection using PCR. They were recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt, which was specifically designated for the isolation of SARS-CoV-2 positive patients. According to the Egyptian ministry of health and population's (MOHP) recommendations, patients were divided into 80 mild-moderate COVID-19 patients and 80 severe COVID-19 patients. Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent), while severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent). All participants or their corresponding companions signed a free informed consent form. The study was approved by the research ethics committee of Al-Azhar University's Faculty of Medicine (Girls), Cairo, Egypt, with approval number (202106884), and adhered to the Helsinki Declaration's precepts. Pregnancy, COVID-19 patients with morbid obesity, cancer, or autoimmune disease, and those who took immunomodulators or initiated the COVID-19 treatment programme were excluded. Additionally, patients having a history of recurrent COVID-19 infection were excluded from the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian patients recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients \\> 18 years with the positive result of real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) for SARS-CoV-2 RNA.\n\nSeverity stratification is based on the guidance of the Egyptian MOH protocol.\n\nExclusion Criteria:\n\nPregnant COVID-19 patients. COVID-19 patients with morbid obesity, malignancy, autoimmune diseases and those who received immunomodulators or began COVID-19 treatment protocol.\n\nAlso, patients with a history of recurrent COVID-19 will be excluded.'}, 'identificationModule': {'nctId': 'NCT05249751', 'briefTitle': 'Copeptin in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Copeptin; A Neuroendocrine Biomarker of COVID-19 Severity', 'orgStudyIdInfo': {'id': 'Al-Azhar Pharmacy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild-moderate', 'description': 'Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent),', 'interventionNames': ['Diagnostic Test: Assessement of serum copeptin by ELISA technique']}, {'label': 'Severe', 'description': 'severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent).', 'interventionNames': ['Diagnostic Test: Assessement of serum copeptin by ELISA technique']}], 'interventions': [{'name': 'Assessement of serum copeptin by ELISA technique', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessement of serum copeptin by ELISA technique', 'armGroupLabels': ['Severe', 'mild-moderate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al-Zahraa Hospital, Al-Azhar University, Cairo, Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Through the published research article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Assistant of Medical Biochemistry and Molecular Biology', 'investigatorFullName': 'Ahmed Elshafei', 'investigatorAffiliation': 'Al-Azhar University'}}}}