Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT05143320
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive and neuropsychiatirc symptoms in Covid-19 patients', 'timeFrame': 'About 20 days after hospital dismission', 'description': 'Prevalence of neuropsychological and neuropsychiatric impairment in patients after hospitalization in patients with Sars-Cov2 infection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Cognition', 'Teleneuropsychology', 'Memory', 'Executive Functions'], 'conditions': ['COVID-19', 'Sars-CoV-2 Infection']}, 'referencesModule': {'references': [{'pmid': '35686079', 'type': 'DERIVED', 'citation': 'Cian V, De Laurenzis A, Siri C, Gusmeroli A, Canesi M. Cognitive and Neuropsychiatric Features of COVID-19 Patients After Hospital Dismission: An Italian Sample. Front Psychol. 2022 May 24;13:908363. doi: 10.3389/fpsyg.2022.908363. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Recent studies suggest cognitive, emotional and behavioural impairments occur in patients after SARS-CoV-2 infection. Problems with memory, attention, information processing and executive functions are particularly prevalent in these patients, probably due to hypothesised sensitivity of the hippocampus to the virus. Cognitive impairment is also present in patients with no neurological, neuropsychological and neuropsychiatric history. Therefore, the aim of the present study is to describe neuropsychological and neuropsychiatric features in patients recovered from moderate to severe forms of Covid-19 some weeks after hospital dismission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were hospitalized in the Covid ward and recovered from the acute phase of Covid-19 with no need of ICU admission. All patients had SARS-Cov-2 infection confirmed by positive PCR from nasopharyngeal swab. Neuropsychological study was performed on average 20 days after hospital discharge to have the most recent possible cognitive profile related to the infection. We enrolled 29 healthy controls (Covid-) who did not have SARS COV 2 infections with a 1:1 match by age, education and gender.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive PCR from nasopharyngeal swab\n* No ICU admission\n\nExclusion Criteria:\n\n* Diagnosis of neurologic or psychiatric disorders;\n* Previous cognitive impairment;\n* Other medical conditions negatively affecting the cognitive status.'}, 'identificationModule': {'nctId': 'NCT05143320', 'briefTitle': 'Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Generale Di Zona Moriggia-Pelascini'}, 'officialTitle': 'Cognitive and Neuropsychiatric Features of COVID-19 Patients After Hospital Dismission: an Italian Sample.', 'orgStudyIdInfo': {'id': 'NPS impairment in Covid-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid+'}, {'label': 'Covid-'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22015', 'city': 'Gravedona', 'state': 'Como', 'country': 'Italy', 'facility': '"Moriggia Pelascini" Hospital', 'geoPoint': {'lat': 46.14639, 'lon': 9.30094}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Generale Di Zona Moriggia-Pelascini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}