Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT04581135
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2020-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Coded biological material'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 620}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary follow-up sequelae in patients after COVID-19', 'timeFrame': '36 months', 'description': 'Number of patients with the long-term pulmonary complications by measuring lung function, exercise testing and radiological Imaging'}, {'measure': 'Evaluation of risk factors for adverse Outcome after COVID-19', 'timeFrame': '36 months', 'description': 'Number of patients with risk factors including comorbidities and other cofactors and correlate them to adverse outcome in patients after COVID-19'}], 'secondaryOutcomes': [{'measure': 'Compare the functional Pulmonary outcome of COVID-19 disease', 'timeFrame': '36 months', 'description': 'Compare pulmonary function measurements between mild and moderate to severe and critical COVID-19 disease'}, {'measure': 'Compare the radiological Pulmonary outcome of COVID-19 disease', 'timeFrame': '36 months', 'description': 'Compare imaging measurements between mild and moderate to severe and critical COVID-19 disease'}, {'measure': 'Quality of Life after COVID-19', 'timeFrame': '36 months', 'description': 'Compare Quality of Life questionnaires between mild and moderate to severe and critical COVID-19 disease'}, {'measure': 'Physical performance after COVID-19 using Clinical Frailty Scale', 'timeFrame': '36 months', 'description': 'To observe and compare the physical performance after COVID-19 via the Clinical Frailty Scale between mild and moderate to severe and critical COVID-19 disease'}, {'measure': 'Physical performance after COVID-19 using frailty assessment tests', 'timeFrame': '36 months', 'description': 'To observe and compare the physical performance after COVID-19 via frailty assessment tests between mild and moderate to severe and critical COVID-19 disease'}, {'measure': 'Microbiota and COVID-19', 'timeFrame': '36 months', 'description': 'Number of patients with changes in microbiota in response to COVID-19 by microbiota analysis of sputa, bronchoalveolar lavage and swaps'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Coronavirus infection', 'Lung abnormalities', 'Radiological abnormalities', 'ARDS', 'Quality of Life'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '37789266', 'type': 'DERIVED', 'citation': 'Abu Hussein N, Machahua C, Ruchti SC, Horn MP, Piquilloud L, Prella M, Geiser TK, von Garnier C, Funke-Chambour M. Circulating calprotectin levels four months after severe and non-severe COVID-19. BMC Infect Dis. 2023 Oct 3;23(1):650. doi: 10.1186/s12879-023-08653-7.'}]}, 'descriptionModule': {'briefSummary': 'Prospective Observational Swiss Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19.', 'detailedDescription': 'COVID-19 is a coronavirus induced viral pneumonia leading to Acute Respiratory Distress Syndrome. Previous coronavirus infections (SARS and MERS) led to pulmonary fibrosis in up to 30%. Prospective evaluation of lung abnormalities and pulmonary fibrosis after COVID-19 infection is crucial as novel treatments against lung fibrosis of different etiologies are available. No data on pulmonary longterm effects in COVID-19 survivors are currently available. The nation-wide Swiss COVID-19 lung group establishes a meticulously characterized prospective cohort study on pulmonary long-term sequela of patients living in Switzerland.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients included are survivors of COVID-19.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent.\n* All adult patients with COVID-19 over 18 years.\n\nExclusion Criteria:\n\n* Severe mental or physical disability precluding informed consent or compliance with the protocol for prospective data collection.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT04581135', 'briefTitle': 'Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Prospective Observational Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19', 'orgStudyIdInfo': {'id': '2020-00799'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 Lung', 'description': 'COVID-19 survivors in Switzerland', 'interventionNames': ['Other: COVID-19']}], 'interventions': [{'name': 'COVID-19', 'type': 'OTHER', 'otherNames': ['Sampling biological material', 'Collection of health-related personal data'], 'description': 'Research project in which biological material is sampled and health-related personal data are collected and used for further research. Coded data are used.', 'armGroupLabels': ['COVID-19 Lung']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4002', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'St. Claraspital AG - Department of Pulmonary Medicine', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universtiy Hospital Bern (Inselspital), Department of Pulmonary Medicine - Lead Center', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1708', 'city': 'Fribourg', 'country': 'Switzerland', 'facility': 'University and Hospital of Fribourg', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève - Service de Pneumologie', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'CHUV - Service de Pneumologie', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Clinica Moncucco', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonspital St. Gallen - Klinik für Pneumologie und Schlafmedizin Lungenzentrum', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '1950', 'city': 'Sion', 'country': 'Switzerland', 'facility': 'Hôpital du Valais - Service de Pneumologie', 'geoPoint': {'lat': 46.22739, 'lon': 7.35559}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich - Klinik für Pneumologie', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Manuela Funke-Chambour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bern, Department of Pulmonary Medicine - Lead Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}