Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT04724434
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Study of COVID-19 Patients in the District Konstanz
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], '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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'In the Control group a SARS-CoV-2 antibody test will be performed.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 526}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-23', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Hospitalization', 'timeFrame': 'Between 1 year after enrollment and 5 years after last patient in', 'description': 'Primary endpoint'}], 'secondaryOutcomes': [{'measure': 'EQ-5D-5L', 'timeFrame': 'Between 1 year after enrollment and 5 years after last patient in', 'description': 'Secondary endpoint'}, {'measure': 'KCCQ-12', 'timeFrame': 'Between 1 year after enrollment and 5 years after last patient in', 'description': 'Secondary endpoint'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 Virus disease', 'SARS-CoV-2', 'Hospitalization', 'Quality of life', 'EQ-5D-5L', 'Cardiomyopathy, Kansas City (KCCQ-12)'], 'conditions': ['SARS-CoV-2 Positive Patients']}, 'referencesModule': {'references': [{'pmid': '36035510', 'type': 'BACKGROUND', 'citation': 'Haberland E, Haberland J, Richter S, Schmid M, Hromek J, Zimmermann H, Geng S, Winterer H, Schneider S, Kollum M. Seven Months after Mild COVID-19: A Single-Centre Controlled Follow-Up Study in the District of Constance (FSC19-KN). Int J Clin Pract. 2022 Aug 12;2022:8373697. doi: 10.1155/2022/8373697. eCollection 2022.'}, {'pmid': '40094912', 'type': 'BACKGROUND', 'citation': 'Kohler AK, Richter S, Schmid M, Zimmermann H, Winterer H, Schneider S, Kollum M. Three-Year Follow-Up of COVID-19 Cases in District of Constance, Germany. A Prospective, Controlled Cohort Study (FSC19-KN). J Clin Med. 2025 Feb 21;14(5):1439. doi: 10.3390/jcm14051439.'}]}, 'descriptionModule': {'briefSummary': "This is a prospective single-center study for the follow-up of SARS-CoV-2 positive patients in the district of Konstanz (LKN). As part of the coronavirus pandemic, patients with SARS-CoV-2 infection are currently being treated in the clinics of the LKN's health network at the Singen (Hegau-Bodensee Clinic) and Konstanz (Konstanz Clinic) locations. So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part of this study, the disease progression of these patients will be monitored. Study objective: Prospective, controlled follow-up observation of SARS-CoV-2 positive patients regarding their secondary diseases and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The SARS-CoV-2 positive patients in the Konstanz district are invited to participate in the study by information letter. The addressing and sending of the study documents will take place via the Health Department of the district of Konstanz. The study team only gets knowledge of those positively tested patients who responded to the cover letter and declare their informed consent to the study.\n\nProbands for the control group will be contacted and invited to the study by announcements in local newspapers and flyers in our hospital. Only those probands are included to the study, who can be matched to one participant of the SARS-CoV-2 positive group by age, gender and cardiovascular risk factors such as smoking, diabetes mellitus and arterial hypertension.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA Inclusion Criteria of SARS-CoV-2 positive patients:\n\nPatient must meet all of the following criteria.\n\n1. Positive test for SARS-CoV-2 by PCR\n2. Signed informed consent and privacy policy\n\nB Inclusion Criteria of the control Group:\n\nVolunteer must meet all of the following criteria.\n\n1. No contact to SARS-CoV-2 positive patients\n2. negative SARS-CoV-2 antibody test\n3. Signed informed consent and privacy policy\n\nExclusion Criteria:\n\nPatient/Volunteer will be excluded if any of the following conditions apply:\n\n1. Patient/Volunteer age \\< 18 years\n2. Patient/Volunteer who are unable to read the information and understand the nature of the study\n3. Patient/Volunteer participate in any other clinical study'}, 'identificationModule': {'nctId': 'NCT04724434', 'acronym': 'FSC19-KN', 'briefTitle': 'Follow-up Study of COVID-19 Patients in the District Konstanz', 'organization': {'class': 'OTHER', 'fullName': 'Hegau-Bodensee-Klinikum Singen'}, 'officialTitle': 'Single Center Prospective Controlled Follow-up Study of COVID-19 Patients in the District Konstanz (FSC19-KN)', 'orgStudyIdInfo': {'id': '20-1020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with positive test for SARS-CoV-2 by PCR'}, {'label': 'Control group', 'description': 'Patients with negative SARS-CoV-2 antibody test'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78224', 'city': 'Singen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Hegau-Bodensee-Klinikum Singen', 'geoPoint': {'lat': 47.75935, 'lon': 8.8403}}], 'overallOfficials': [{'name': 'Marc Kollum, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hegau-Bodensee-Klinikum Singen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hegau-Bodensee-Klinikum Singen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health and Human Services', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiology and Internal Medicine', 'investigatorFullName': 'PD Dr. med. Marc Kollum', 'investigatorAffiliation': 'Hegau-Bodensee-Klinikum Singen'}}}}