Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 3:53 PM
Study NCT ID:
NCT04559100
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus
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': 'D014965', 'term': 'X-Rays'}, {'id': 'D013147', 'term': 'Spirometry'}, {'id': 'D000070857', 'term': 'Walk Test'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung function', 'timeFrame': '6 months after hospital discharge', 'description': 'Spirometry in Liters'}, {'measure': 'Lung function', 'timeFrame': '12 months after hospital discharge', 'description': 'Spirometry in Liters'}, {'measure': 'Lung function', 'timeFrame': '6 months after hospital discharge', 'description': 'Diffusing capacity of carbon monoxide (% predicted)'}, {'measure': 'Lung function', 'timeFrame': '12 months after hospital discharge', 'description': 'Diffusing capacity of carbon monoxide (% predicted)'}, {'measure': 'Lung function', 'timeFrame': '6 months after hospital discharge', 'description': '6 min walk test in Meters'}, {'measure': 'Lung function', 'timeFrame': '12 months after hospital discharge', 'description': '6 min walk test in Meters'}, {'measure': 'Radiological alterations', 'timeFrame': '6 months after hospital discharge', 'description': 'Alterations in chest radiography'}, {'measure': 'Radiological alterations', 'timeFrame': '12 months after hospital discharge', 'description': 'Alterations in chest radiography'}, {'measure': 'Radiological alterations', 'timeFrame': '6 months after hospital discharge', 'description': 'Alterations in thoracic CT scan'}, {'measure': 'Radiological alterations', 'timeFrame': '12 months after hospital discharge', 'description': 'Alterations in thoracic CT scan'}, {'measure': 'Quality of life alterations', 'timeFrame': '6 months after hospital discharge', 'description': 'Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)'}, {'measure': 'Quality of life alterations', 'timeFrame': '12 months after hospital discharge', 'description': 'Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid19', 'lung function', 'quality of life'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a severe or critical disease caused by SARS-COV-2 infection who were treated at the ICU of Fundación Valle del Lili and were alive at 6 months of hospital discharge.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 19 years old who had a positive test for SARS-COV-2 virus\n* Patients with a severe and critical disease by SARS-COV-2, who were treated at the ICU of Fundación Valle del Lili, and survived\n* Patients with chest radiography or CT scan at admission to the hospital\n\nExclusion Criteria:\n\n* Patients who do not sign informed consent.'}, 'identificationModule': {'nctId': 'NCT04559100', 'briefTitle': 'Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinica Valle del Lili'}, 'officialTitle': 'Clinical, Radiological, Lung Function, and Quality of Life Characterization of Patients With Severe/Critical Infection by SARS-COV-2 (COVID-19) Virus, After 6 and 12 Months of Hospital Discharge', 'orgStudyIdInfo': {'id': '1631 COVID-LFT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe and critical COVID-19 survivors', 'description': 'Radiological alterations assessed by chest radiography and/or thoracic computed tomography Lung function alterations assessed by spirometry, diffusing capacity for carbon monoxide, 6 minute walk.\n\nQuality of life alterations: saint george respiratory questionnaire', 'interventionNames': ['Radiation: chest radiography', 'Radiation: thoracic computed tomography scan', 'Diagnostic Test: spirometry', 'Diagnostic Test: Diffusing capacity of carbon monoxide', 'Diagnostic Test: 6 minute walk test', 'Diagnostic Test: saint george respiratory questionnaire']}], 'interventions': [{'name': 'chest radiography', 'type': 'RADIATION', 'description': '6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.', 'armGroupLabels': ['Severe and critical COVID-19 survivors']}, {'name': 'thoracic computed tomography scan', 'type': 'RADIATION', 'description': '6 and 12 months after hospital discharge, if the patient had a CT scan upon admission to the hospital. If the study is normal at 6 months it will not be repeated at 12 months.', 'armGroupLabels': ['Severe and critical COVID-19 survivors']}, {'name': 'spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': '6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.', 'armGroupLabels': ['Severe and critical COVID-19 survivors']}, {'name': 'Diffusing capacity of carbon monoxide', 'type': 'DIAGNOSTIC_TEST', 'description': '6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.', 'armGroupLabels': ['Severe and critical COVID-19 survivors']}, {'name': '6 minute walk test', 'type': 'DIAGNOSTIC_TEST', 'description': '6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.', 'armGroupLabels': ['Severe and critical COVID-19 survivors']}, {'name': 'saint george respiratory questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': '6 and 12 months after hospital discharge.', 'armGroupLabels': ['Severe and critical COVID-19 survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '760001', 'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Fundacion Valle del Lili', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}], 'overallOfficials': [{'name': 'Fernandez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion Clinica Valle del Lili'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinica Valle del Lili', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}