Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT05225194
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diffusion capacity for carbon monoxide', 'timeFrame': 'The outcome will be assessed 6 months after enrollment', 'description': 'Proportion of participants with diffusion capacity for carbon monoxide \\< 80% of predicted'}], 'secondaryOutcomes': [{'measure': 'Physical functional status', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence)'}, {'measure': 'Instrumental Activities of Daily Living', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'The outcome will be assessed using the Lawton \\& Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence)'}, {'measure': 'Muscular function and strength', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'Muscular function and strength as assessed by Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire. Scale scores range from 0 (best) to 10 (worst)'}, {'measure': 'Score of dyspnea', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'The outcome will be assessed using the modified medical research council dyspnea scale. Scores ranges from 0 to 4, with higher scores indicating worse symptoms.'}, {'measure': 'Utility score of health related quality of life', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).'}, {'measure': 'Radiologic patterns of intersticial lung disease', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Radiologic patterns of intersticial lung disease as assessed by high resolution computed tomography chest scan.'}, {'measure': 'Radiologic patterns of myocarditis sequalae', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Radiologic patterns of myocarditis sequalae as assessed by cardiac magnetic resonance imaging'}, {'measure': 'Radiologic patterns of sarcopenia', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Radiologic patterns of sarcopenia as assessed by high resolution computed tomography chest scan.'}, {'measure': 'Incidence of major cardiovascular events', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death)'}, {'measure': 'Incidence of thromboembolic events', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'Incidence of thromboembolic events (composite endpoint of pulmonary embolism and deep venous thrombosis)'}, {'measure': 'Incidence of all-cause mortality', 'timeFrame': 'The outcome will be assessed at 3 and 6 months after enrollment', 'description': 'Incidence of all-cause mortality'}, {'measure': 'Percentage of predicted peak oxygen consumption', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Percentage of predicted peak oxygen consumption as assessed by treadmill cardiopulmonary exercise cardiopulmonary exercise'}, {'measure': 'Peak oxygen consumption', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Peak oxygen as assessed by treadmill cardiopulmonary exercise'}, {'measure': 'Peak oxygen pulse', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise'}, {'measure': 'Oxygen uptake efficiency slope', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Oxygen uptake efficiency slope as assessed by treadmill cardiopulmonary exercise'}, {'measure': 'Minute ventilation/carbon dioxide production slope ratio', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Minute ventilation/carbon dioxide production slope as assessed by treadmill cardiopulmonary exercise'}, {'measure': 'Forced vital capacity', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Forced expiratory capacity as assessed by spirometry'}, {'measure': 'Forced expiratory volume in one second', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Forced expiratory volume in one second as assessed by spirometry'}, {'measure': 'Forced expiratory volume in one second/ Forced vital capacity ratio', 'timeFrame': 'The outcome will be assessed at 6 months after enrollment', 'description': 'Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'ARDS']}, 'descriptionModule': {'briefSummary': 'The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS).\n\nThis is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization', 'eligibilityCriteria': 'COHORT OF SURVIVORS OF ARDS CAUSED BY COVID-19\n\nInclusion Criteria:\n\n* Age ≥18 years;\n* Hospitalization due to COVID-19;\n* Positive polymerase chain reaction (PCR) test for SARS-CoV-2;\n* Diagnosis of ARDS during hospitalization according to the Berlin definition;\n* Expected to survive and be discharged directly home from the hospital.\n\nExclusion Criteria:\n\n* Severe comorbidity with life expectancy less than 3 months;\n* Unavailability to attend the study follow-up appointment;\n* Death during hospitalization;\n* Absence of proxy for patients with communication difficulties;\n* Refusal or withdrawal of agreement to participate.\n\nCOHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19\n\nInclusion Criteria:\n\n* Age ≥18 years;\n* Hospitalization;\n* Diagnosis of ARDS during hospitalization according to the Berlin definition;\n* Expected to survive and be discharged directly home from the hospital.\n\nExclusion Criteria:\n\n* Severe comorbidity with life expectancy less than 3 months;\n* Unavailability to attend the study follow-up appointment;\n* Death during hospitalization;\n* History of SARS-CoV-2 infection within the last 12 months;\n* Absence of proxy for patients with communication difficulties;\n* Refusal or withdrawal of agreement to participate.\n\nFAMILY CONTROLS\n\nInclusion Criteria:\n\n* Age ≥18 years;\n* Family member of a enrolled participant (either from the COVID-19 ARDS cohort or from the non-COVID-19 ARDS cohort)\n\nExclusion Criteria:\n\n* Severe comorbidity with life expectancy less than 3 months;\n* Unavailability to attend the study follow-up appointment;\n* History of SARS-CoV-2 infection within the last 12 months;\n* History of non-elective hospitalization due to medical condition within the last 12 months;\n* Refusal or withdrawal of agreement to participate.'}, 'identificationModule': {'nctId': 'NCT05225194', 'briefTitle': 'Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Moinhos de Vento'}, 'officialTitle': 'Prospective Study for the Assessment of Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil', 'orgStudyIdInfo': {'id': 'Pos-COVID Brasil 3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 ARDS survivors', 'description': 'Survivors of hospitalization due to ARDS caused by SAS-CoV-2.', 'interventionNames': ['Other: COVID-19', 'Other: ARDS']}, {'label': 'Non-COVID-19 ARDS survivors', 'description': 'Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.', 'interventionNames': ['Other: ARDS']}, {'label': 'Family controls', 'description': 'Family controls of participants with ARDS (either due to COVID-19 or other etiologies) without history of COVID-19 or hospitalization in the last 12 months.'}], 'interventions': [{'name': 'COVID-19', 'type': 'OTHER', 'description': 'SARS-CoV-2 infection', 'armGroupLabels': ['COVID-19 ARDS survivors']}, {'name': 'ARDS', 'type': 'OTHER', 'description': 'Acute respiratory distress syndrome', 'armGroupLabels': ['COVID-19 ARDS survivors', 'Non-COVID-19 ARDS survivors']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Geraldine Trott, PhD', 'role': 'CONTACT', 'email': 'geraldine.trott@hmv.org.br', 'phone': '+5551994407117'}], 'overallOfficials': [{'name': 'Regis G Rosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Moinhos de Vento'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Moinhos de Vento', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}