Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-28 @ 8:09 PM
Study NCT ID:
NCT05293561
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Impact in Patients With COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive impairment', 'timeFrame': '1 month', 'description': 'degree of affection in cognition due to COVID-19 infection'}], 'secondaryOutcomes': [{'measure': 'Level of Anxiety and depression among COVID-19 cases', 'timeFrame': '1 month', 'description': 'Level of Anxiety and depression among COVID-19 cases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19; Cognitive Impairment; Anxiety; Depression'], 'conditions': ['Cognitive Impairment', 'COVID-19 Respiratory Infection']}, 'referencesModule': {'references': [{'pmid': '33556127', 'type': 'BACKGROUND', 'citation': 'Alemanno F, Houdayer E, Parma A, Spina A, Del Forno A, Scatolini A, Angelone S, Brugliera L, Tettamanti A, Beretta L, Iannaccone S. COVID-19 cognitive deficits after respiratory assistance in the subacute phase: A COVID-rehabilitation unit experience. PLoS One. 2021 Feb 8;16(2):e0246590. doi: 10.1371/journal.pone.0246590. eCollection 2021.'}, {'pmid': '33364996', 'type': 'BACKGROUND', 'citation': 'Germani A, Buratta L, Delvecchio E, Gizzi G, Mazzeschi C. Anxiety Severity, Perceived Risk of COVID-19 and Individual Functioning in Emerging Adults Facing the Pandemic. Front Psychol. 2020 Dec 7;11:567505. doi: 10.3389/fpsyg.2020.567505. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'SARS-COV-2 (severe acute respiratory syndrome- corona virus - 2) infection reframed medical knowledge in many aspects, yet there is still a lot to be discovered. Coronavirus disease 19 (COVID-19) can cause neuropsychiatric, psychological and psychosocial impairments. Literature regarding cognitive impact of COVID-19 is still limited.\n\nObjective: evaluation of cognitive function, anxiety and depression among patients with Coronavirus disease 19.', 'detailedDescription': "COVID-19 results in a variety of symptoms with multi-organ affection, including fever, cough; grave respiratory symptoms, gastrointestinal manifestations and fatigue. As more is learned, neurological and psychological symptoms appear to manifest in a large subscale of patients. Headache, dizziness and even a cerebrovascular event have been reported. Anosmia and ageusia reported as early indicators of SARS-CoV-2 infection, suggesting that early neurological involvement may be relevant.\n\nPublic health emergencies as COVID-19 are likely to cause adverse neuropsychiatric impacts. Cognitive impairments after SARS-COV-2 infection were noticed, COVID-19 patients complain of poor concentration, declined memory, and insomnia, as well as anxiety and depression symptoms.\n\nThe battle against COVID-19 is still continuing worldwide. People's adherence to confinement regulations and response to vaccination campaigns is essential, which is largely affected by their knowledge, attitudes, and practices towards COVID-19. Home isolation and social distancing are also associated with fear, frustrations, uncertainty, anxiety and depressive symptoms.\n\nDuring the acute phase of COVID-19 infection, about 36% of cases develop neurological symptoms of which 25% can be attributed to the direct involvement of the central nervous system. Patients who show neurological symptoms included cases with or without pre-existing neurological disorders. While on intensive care units, patients showed agitation, confusion, and corticospinal tract signs such as enhanced tendon reflexes and clonus. COVID-19 can further lead to changes of coagulation and, in particular, to inflammation-induced disseminated intravascular coagulation (DIC)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis and healthy control belonging to either gender. COVID-19 patients recruited from home isolation at first visit in outpatient clinic and then after end of isolation period for 14 days, patients included from hospital isolation ward; also recruited from the respiratory isolation ICU, chest department of Assiut university hospital.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* COVID-19 patients diagnosed using Real Time-Polymerase Chain Reaction to confirm the diagnosis\n\nExclusion Criteria:\n\n* neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions"}, 'identificationModule': {'nctId': 'NCT05293561', 'briefTitle': 'Cognitive Impact in Patients With COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Cognitive Impact in Patients With COVID-19 Infection', 'orgStudyIdInfo': {'id': 'WGEK-NCG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 cases', 'description': "O2 saturation readings, Mini-mental state examination (MMSE), Hamilton's anxiety (HAM-A) Hamilton's depression rating scales (HAM-D)"}, {'label': 'control', 'description': "O2 saturation readings, Mini-mental state examination (MMSE), Hamilton's anxiety (HAM-A) Hamilton's depression rating scales (HAM-D)"}]}, 'contactsLocationsModule': {'locations': [{'zip': '711111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Waleed Gamal elddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut university hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Chest diseases and tuberculosis', 'investigatorFullName': 'Waleed Gamal Elddin Khaleel', 'investigatorAffiliation': 'Assiut University'}}}}