Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-02 @ 1:13 AM
Study NCT ID:
NCT04314232
Status:
UNKNOWN
Last Update Posted:
2020-06-26
First Post:
2020-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms for Covid-19 Disease Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2020-03-17', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with ICU admission or death', 'timeFrame': 'From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)', 'description': 'Combined outcome measure of either ICU admission or death'}], 'secondaryOutcomes': [{'measure': 'Number of participants with ICU admission', 'timeFrame': 'From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)', 'description': 'ICU admission'}, {'measure': 'Number of participants with death from all causes', 'timeFrame': 'From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)', 'description': 'Hospital mortality'}, {'measure': 'Total duration of ICU stay', 'timeFrame': 'From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)', 'description': 'Total time admitted to the ICU'}, {'measure': 'Total duration of hospital stay', 'timeFrame': 'From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Biomarkers', 'Cardiovascular disease', 'Prognosis'], 'conditions': ['COVID', 'Coronavirus Infection']}, 'referencesModule': {'references': [{'pmid': '34933965', 'type': 'DERIVED', 'citation': 'Omland T, Prebensen C, Jonassen C, Svensson M, Berdal JE, Seljeflot I, Myhre PL. Soluble ST2 concentrations associate with in-hospital mortality and need for mechanical ventilation in unselected patients with COVID-19. Open Heart. 2021 Dec;8(2):e001884. doi: 10.1136/openhrt-2021-001884.'}, {'pmid': '34400140', 'type': 'DERIVED', 'citation': 'Myhre PL, Heck SL, Skranes JB, Prebensen C, Jonassen CM, Berge T, Mecinaj A, Melles W, Einvik G, Ingul CB, Tveit A, Berdal JE, Rosjo H, Lyngbakken MN, Omland T. Cardiac pathology 6 months after hospitalization for COVID-19 and association with the acute disease severity. Am Heart J. 2021 Dec;242:61-70. doi: 10.1016/j.ahj.2021.08.001. Epub 2021 Aug 13.'}, {'pmid': '33596668', 'type': 'DERIVED', 'citation': 'Myhre PL, Prebensen C, Jonassen CM, Berdal JE, Omland T. SARS-CoV-2 Viremia is Associated With Inflammatory, But Not Cardiovascular Biomarkers, in Patients Hospitalized for COVID-19. J Am Heart Assoc. 2021 May 4;10(9):e019756. doi: 10.1161/JAHA.120.019756. Epub 2021 Feb 18.'}, {'pmid': '33058695', 'type': 'DERIVED', 'citation': 'Myhre PL, Prebensen C, Strand H, Roysland R, Jonassen CM, Rangberg A, Sorensen V, Sovik S, Rosjo H, Svensson M, Berdal JE, Omland T. Growth Differentiation Factor 15 Provides Prognostic Information Superior to Established Cardiovascular and Inflammatory Biomarkers in Unselected Patients Hospitalized With COVID-19. Circulation. 2020 Dec;142(22):2128-2137. doi: 10.1161/CIRCULATIONAHA.120.050360. Epub 2020 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'Covid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. Several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with Covid-19 remains unclear. This study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with SARS-CoV2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a positive test for SARS-CoV2 admitted to Akershus University Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients \\>18 years of age with a positive test for SARS-CoV2 are eligble for inclusion.\n* Healty age-matched volunteers will be included as a control group\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04314232', 'acronym': 'COVID MECH', 'briefTitle': 'Mechanisms for Covid-19 Disease Complications', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19', 'orgStudyIdInfo': {'id': '117589'}}, 'contactsLocationsModule': {'locations': [{'city': 'Lørenskog', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Peder Myhre, MD, PhD', 'role': 'CONTACT', 'email': 'p.l.myhre@medisin.uio.no', 'phone': '6790000'}], 'facility': 'Akershus University Hospital'}], 'centralContacts': [{'name': 'Torbjørn Omland, MD, PhD', 'role': 'CONTACT', 'email': 'torbjorn.omland@medisin.uio.no', 'phone': '67960000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Torbjorn Omland', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}