Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04709120
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2968}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': '4 weeks', 'description': 'death for any reason'}], 'secondaryOutcomes': [{'measure': 'Number of cases of Acute Kidney Injury depending on Coexisting Conditions', 'timeFrame': '4 weeks', 'description': 'Number of cases of Acute Kidney Injury depending on Coexisting Conditions'}, {'measure': 'Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions', 'timeFrame': '4 weeks', 'description': 'Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions'}, {'measure': 'Number of cases of Cytokine Storm depending on Coexisting Conditions', 'timeFrame': '4 weeks', 'description': 'Number of cases of Cytokine Storm depending on Coexisting Conditions'}, {'measure': 'Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions', 'timeFrame': '4 weeks', 'description': 'Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions'}, {'measure': 'Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions', 'timeFrame': '4 weeks', 'description': 'Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions'}, {'measure': 'Rate of cases of health status worsening occured during hospitalisation', 'timeFrame': '4 weeks', 'description': 'Rate of cases of health status worsening occured during hospitalisation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'Comorbidities and Coexisting Conditions', 'Risk Factor', 'SARS-CoV-2', 'COVID-19 Second Wave', 'COVD-19 First Wave', 'Death'], 'conditions': ['Covid19', 'Comorbidities and Coexisting Conditions', 'Risk Factor, Cardiovascular', 'Death', 'Diabetes', 'COPD', 'Atrial Fibrillation', 'DVT', 'CKD']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://russjcardiol.elpub.ru/jour/article/view/4358/', 'label': 'design of observational studies "Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients" and "Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection"'}, {'url': 'https://russjcardiol.elpub.ru/jour/article/view/5042', 'label': 'Lipid profile in hospitalized patients with COVID-19 depending on the outcome of its acute phase: data from the international registry "Dynamics analysis of comorbidities in SARS-CoV-2 infection survivors"'}, {'url': 'https://www.medarhive.ru/jour/article/view/1594/1214', 'label': 'Impact of Kidney Damage on the Course and Prognosis of COVID-19 Infection According to the International Registry "Analysis of Chronic Non-Infectious Diseases Dynamics After Covid-19 Infection in Adult Patients"'}, {'url': 'https://www.probl-endojournals.ru/jour/article/view/13175', 'label': 'The impact of carbohydrate metabolism disorders on the early and long-term clinical outcomes of patients with COVID-19 according to the AKTIV and AKTIV 2 registries.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection', 'detailedDescription': 'Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 in first and second waves of the novel coronavirus infection in cohort of Russian adult patients.\n\nRetrospective analysis of medical histories and outcomes in adults with pre-existing conditions after SARS-CoV-2 infection. Comorbidities worsening risk factors measuring through evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma, incidence of hypertonic crises, vascular events and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anonymized male and female patients over the age of 18 hospitalised since October, 1st, 2020', 'eligibilityCriteria': 'Inclusion Criteria:\n\nSuspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)\n\nExclusion Criteria:\n\n1. Unwillingness to participate in the study;\n2. Age under 18.'}, 'identificationModule': {'nctId': 'NCT04709120', 'acronym': 'ACTIV-2', 'briefTitle': 'Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Eurasian Association of Therapists'}, 'officialTitle': 'Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection', 'orgStudyIdInfo': {'id': 'ACTIV-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '101000', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Eurasian Association of Therapists', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Grigoriy Arutyunov, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eurasian Association of Therapists'}, {'name': 'Ekaterina Tarlovskaya, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Eurasian Association of Therapists'}, {'name': 'Aleksander Arutyunov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurasian Association of Therapists'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurasian Association of Therapists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Eurasian Association of Therapists', 'investigatorFullName': 'Tamara Kriukova', 'investigatorAffiliation': 'Eurasian Association of Therapists'}}}}