Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 9:30 AM
Study NCT ID:
NCT04496128
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2020-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID19 Neurological Manifestation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-30', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of neurological manifestations', 'timeFrame': 'During hospital course, up to 1 month', 'description': 'Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.'}, {'measure': 'Hospital Mortality', 'timeFrame': 'At hospital discharge, approximately 1 month'}, {'measure': 'Global functional outcomes using modified Rankin score', 'timeFrame': 'At hospital discharge, approximately 1 month', 'description': 'Patients will be assessed on a scale score of 0 (no symptoms at all) to 5 (severe disability; bedridden, incontinent and requiring constant nursing care and attention)'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': 'At hospital discharge, approximately 1 month'}, {'measure': 'Length of hospital stay (in days)', 'timeFrame': 'At hospital discharge, approximately 1 month'}, {'measure': '30-day mortality', 'timeFrame': '30 days from the first day of hospitalization'}, {'measure': '90-day mortality', 'timeFrame': '90 days from the first day of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV 2', 'Neurologic Manifestations']}, 'referencesModule': {'references': [{'pmid': '32346843', 'type': 'BACKGROUND', 'citation': 'Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.'}, {'pmid': '32445105', 'type': 'BACKGROUND', 'citation': 'Frontera J, Mainali S, Fink EL, Robertson CL, Schober M, Ziai W, Menon D, Kochanek PM, Suarez JI, Helbok R, McNett M, Chou SH; GCS-NeuroCOVID Study. Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale. Neurocrit Care. 2020 Aug;33(1):25-34. doi: 10.1007/s12028-020-00995-3.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective observational cohort study to document the prevalence and types of neurological manifestations among hospitalized patients with confirmed or suspected novel coronavirus infection (COVID-19).', 'detailedDescription': 'This study is a prospective observational cohort study to document the prevalence and types of neurological manifestations among hospitalized patients with confirmed or suspected novel coronavirus infection (COVID-19). Severe acute respiratory syndrome 2 (SARS-CoV-2), the virus that causes COVID-19, shares significant structural and biological similarities with SARS-CoV, which is known to be neuroinvasive particularly with brainstem involvement. There are emerging reports of neurological symptoms associated with COVID-19 infections, including seizures, coma, encephalitis, Guillan-Barre syndrome, and cerebrovascular events including ischemic stroke, ICH, and cerebral venous sinus thromboses. However, the exact prevalence of these conditions and their impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continue to rapidly rise globally, it is imperative to capture prospective data to accurately document prevalence, severity and clinical characterization of neurological components of COVID 19, the influence of treatment regimens of neurological complications, and role of these confounders on patient and organizational outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to acute care hospital who are suspected and/or confirmed to have COVID 19.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients greater than or equal to 18 years old\n* Admitted with suspected or confirmed COVID19 infection\n* Patient exhibiting acute neurological symptoms\n\nExclusion Criteria:\n\n* Patients under the age of 18 years old\n* Pre-existing, baseline severe neurologic dysfunction including baseline coma/vegetative state, baseline quadriparesis, baseline refractory seizure disorder with frequent breakthrough seizures despite anticonvulsant use'}, 'identificationModule': {'nctId': 'NCT04496128', 'briefTitle': 'COVID19 Neurological Manifestation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Neurological Complications of COVID-19', 'orgStudyIdInfo': {'id': 'STUDY20040037'}}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Sherry H Chou, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sherry Hsiang-Yi Chou', 'investigatorAffiliation': 'University of Pittsburgh'}}}}