Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-26 @ 6:06 AM
Study NCT ID:
NCT05822193
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'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': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1694}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post COVID-19 condition according to the WHO definition', 'timeFrame': '3 to 24 months', 'description': 'Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis'}, {'measure': 'EQ5D-3L', 'timeFrame': '3 to 24 months', 'description': 'Health-related quality of life assessed using the EuroQol five-dimensional 3-level descriptive system (EQ5D-3L). This outcome will be considered as primary when Post COVID-19 condition be used as exposure.'}], 'secondaryOutcomes': [{'measure': 'Instrumental activities of daily living', 'timeFrame': '3 to 24 months', 'description': 'Instrumental activities of daily living assessed with the Lawton \\& Brody Instrumental Activities of Daily Living'}, {'measure': 'Functional status', 'timeFrame': '3 to 24 months', 'description': 'Functional status assessed with the Modified Barthel Index'}, {'measure': 'Cognition', 'timeFrame': '3 to 24 months', 'description': 'Cognition assessed with the Telephone Interview for Cognitive Status'}, {'measure': 'Anxiety symptoms', 'timeFrame': '3 to 24 months', 'description': 'Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;'}, {'measure': 'Depression symptoms', 'timeFrame': '3 to 24 months', 'description': 'Depression symptoms assessed with the Hospital Anxiety and Depression Scale;'}, {'measure': 'Posttraumatic stress symptoms', 'timeFrame': '3 to 24 months', 'description': 'Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised'}, {'measure': 'Time to return to work or studies', 'timeFrame': '3 to 24 months', 'description': 'Time to return to work or studies after COVID-19'}, {'measure': 'Healthcare utilization', 'timeFrame': '3 to 24 months', 'description': 'Medical and rehabilitation appointments, medication use and diagnostic tests'}, {'measure': 'Costs', 'timeFrame': '3 to 24 months', 'description': 'Individual health-related and COVID-19-related costs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Acute COVID-19 Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a national retrospective cohort study with internet-based recruitment which intends to enroll 1,694 adult patients with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil. Participants with confirmed symptomatic COVID-19 after january 2022 will be evaluated in order to assess incidence, potential risk factors and impact of post COVID-19 condition according to the WHO definition on health-related quality of life and other relevant patient-centered outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study target population is composed by adult participants with confirmed symptomatic COVID-19 during the SARS-CoV-2 omicron wave in Brazil (January 2022 to date, representing the period of time with absolute dominance of omicron as circulating variant). The study will include patients with distinct levels of acute illness severity (i.e., both outpatients and patients who required hospitalization for COVID-19).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Brazilian resident;\n* Symptomatica COVID-19 confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test for SARS-COV-2 after January 2022, with diagnosis at least 90 days before recruitment.\n\nExclusion Criteria:\n\n* No availability to participate in remote research appointments;\n* Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)\n* Refuse to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05822193', 'briefTitle': 'Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Inova Medical'}, 'officialTitle': 'Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil', 'orgStudyIdInfo': {'id': '2023/001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil', 'interventionNames': ['Other: Multiple exposures']}], 'interventions': [{'name': 'Multiple exposures', 'type': 'OTHER', 'description': 'Exposures variables (observational study): age, gender, education, comorbidities, vaccination status, severity of the acute episode of COVID-19, treatments used for acute COVID-19.', 'armGroupLabels': ['Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cachoeirinha', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Maicon Falavigna', 'role': 'CONTACT'}], 'facility': 'Inova Medical', 'geoPoint': {'lat': -29.95111, 'lon': -51.09389}}], 'centralContacts': [{'name': 'Maicon Falavigna, MD, PhD', 'role': 'CONTACT', 'email': 'maicon@inovamedical.com.br', 'phone': '+5551994408818'}, {'name': 'Régis G Rosa, MD, PhD', 'role': 'CONTACT', 'email': 'regis@inovamedical.com.br', 'phone': '+5551991303877'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'To be disclosed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Medical', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}