Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-30 @ 1:33 PM
Study NCT ID:
NCT04365595
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SARS-CoV-2 Associated Respiratory Failure Recovery (COVID-19 CAir)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality-of-life', 'timeFrame': '3 months', 'description': 'European Quality of Life - 5 Dimensions - 5 Levels Instrument (EQ-5D-5L). Scoring: Index ranges from 1 to \\<0, with lower scores indicating more limitations.'}], 'secondaryOutcomes': [{'measure': 'Anxiety and depression', 'timeFrame': '3 months', 'description': 'Hospital Axiety and Depression Score (HADS). Scoring: Scores range from 0 to 42, with higher scores indicating more anxiety or depression symptoms.'}, {'measure': 'Symptom burden', 'timeFrame': '3 months', 'description': 'COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms due to respiratory limitations.'}, {'measure': 'Spirometry', 'timeFrame': '1 month', 'description': 'Forced expiratory volume in one second (FEV1) in liters and percent predicted.'}, {'measure': 'Spirometry', 'timeFrame': '1 month', 'description': 'Forced vital capacity (FVC) in liters and percent predicted.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV 2', 'COVID']}, 'referencesModule': {'references': [{'pmid': '36188784', 'type': 'DERIVED', 'citation': 'Kohlbrenner D, Kuhn M, Stussi-Helbling M, Nordmann Y, Spielmanns M, Clarenbach CF. Longitudinal Smartphone-Based Post-hospitalisation Symptom Monitoring in SARS-CoV-2 Associated Respiratory Failure: A Multi-Centre Observational Study. Front Rehabil Sci. 2021 Nov 24;2:777396. doi: 10.3389/fresc.2021.777396. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Currently it is unknown a) how fast patients recover after being discharged from hospital and b) what underlying predictors may influence recovery.', 'detailedDescription': 'Study aims:\n\n* To evaluate subjective and objective recovery after discharge from hospital in patients with respiratory failure due to COVID-19.\n* To identify risk factors for COVID-19 associated respiratory failure and prolonged recovery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with SARS-CoV-2 associated respiratory failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalization at University Hospital Zurich due to COVID-19 infection\n* hospital discharge max. 4 weeks ago\n* requiring supplemental oxygen\n\nExclusion Criteria:\n\n* \\<18 years\n* non-German speaking\n* no smartphone access'}, 'identificationModule': {'nctId': 'NCT04365595', 'briefTitle': 'SARS-CoV-2 Associated Respiratory Failure Recovery (COVID-19 CAir)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Recovery in Patients With SARS-CoV-2 Associated Respiratory Failure', 'orgStudyIdInfo': {'id': '2020-00745'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV-2 associated respiratory failure', 'description': 'Participants will receive a daily HrQoL questionnaire on their personal smartphone using the docdok health application during 3 months. A selection of participants will furthermore receive a custom-built home disease monitoring device during 1 month. Both procedures start at least 4 weeks after hospital discharge.', 'interventionNames': ['Other: Questionnaires, spirometry']}], 'interventions': [{'name': 'Questionnaires, spirometry', 'type': 'OTHER', 'description': 'Questionnaires targeting health-related quality-of-life, symptoms, anxiety and depression', 'armGroupLabels': ['SARS-CoV-2 associated respiratory failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Christian F Clarenbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}