Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-05 @ 1:55 AM
Study NCT ID:
NCT04468035
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS on COVID-19 Pneumonia Requiring Mechanical Ventilation
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medium-term evolution between 3 and 6 months', 'timeFrame': 'Month 6', 'description': 'This ouctome corresponds to the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with recourse to ventilatory resuscitation.'}], 'secondaryOutcomes': [{'measure': 'Cognitive impairment at M3', 'timeFrame': 'Month 3', 'description': 'This outcome corresponds to MMSE orientation score.'}, {'measure': 'Cognitive impairment at M6', 'timeFrame': 'Month 6', 'description': 'This outcome corresponds to MMSE orientation score.'}, {'measure': 'Memory Scores at M3', 'timeFrame': 'Month 3', 'description': 'This outcome corresponds to Memory scores.'}, {'measure': 'Memory Scores at M6', 'timeFrame': 'Month 6', 'description': 'This outcome corresponds to Memory scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32383778', 'type': 'BACKGROUND', 'citation': 'Alkeridy WA, Almaghlouth I, Alrashed R, Alayed K, Binkhamis K, Alsharidi A, Liu-Ambrose T. A Unique Presentation of Delirium in a Patient with Otherwise Asymptomatic COVID-19. J Am Geriatr Soc. 2020 Jul;68(7):1382-1384. doi: 10.1111/jgs.16536. Epub 2020 May 16.'}, {'pmid': '32294339', 'type': 'BACKGROUND', 'citation': 'Helms J, Kremer S, Merdji H, Clere-Jehl R, Schenck M, Kummerlen C, Collange O, Boulay C, Fafi-Kremer S, Ohana M, Anheim M, Meziani F. Neurologic Features in Severe SARS-CoV-2 Infection. N Engl J Med. 2020 Jun 4;382(23):2268-2270. doi: 10.1056/NEJMc2008597. Epub 2020 Apr 15. No abstract available.'}, {'pmid': '31762923', 'type': 'BACKGROUND', 'citation': 'Bouattour N, Farhat N, Hadjkacem H, Hdiji O, Sakka S, Dammak M, Mhiri C. [Five-word test calibration in a Tunisian population of healthy subjects]. Pan Afr Med J. 2019 Sep 30;34:58. doi: 10.11604/pamj.2019.34.58.14472. eCollection 2019. French.'}, {'pmid': '27590305', 'type': 'BACKGROUND', 'citation': 'Maillet D, Matharan F, Le Clesiau H, Bailon O, Peres K, Amieva H, Belin C. TNI-93: A New Memory Test for Dementia Detection in Illiterate and Low-Educated Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):896-903. doi: 10.1093/arclin/acw065.'}, {'pmid': '35610098', 'type': 'RESULT', 'citation': 'Vialatte de Pemille C, Ray A, Michel A, Stefano F, Yim T, Bruel C, Zuber M. Prevalence and prospective evaluation of cognitive dysfunctions after SARS due to SARS-CoV-2 virus. The COgnitiVID study. Rev Neurol (Paris). 2022 Oct;178(8):802-807. doi: 10.1016/j.neurol.2022.03.014. Epub 2022 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The new coronavirus pandemic responsible for the severe acute respiratory syndrome SARS-CoV2 requires, in its severe forms, the use of invasive ventilation in intensive care.\n\nThe first patients seen in intensive care presented with neurological symptoms and usually not seen in non-viral ARDS or due to other viral causes. These were mainly restless awakenings, attempts at self-extubation and confusional syndromes. Although the data in the literature do not seem to reveal the presence of SARS-CoV2 in the CSF of these patients, certain elements seem to show parenchymal brain damage with the description of hypometabolism of the frontal regions. In addition, most of these patients present a memory complaint after going into intensive care (personal data not published).\n\nWe do not know to date what is the cognitive and psychic profile of these patients, nor what will be their future evolution. Some patients may require specific neuro-cognitive rehabilitation.\n\nThe aim of this study is to assess the cognitive profile of patients infected with COVID-19 who have used invasive ventilation in the intensive care unit of Paris Saint-Joseph hospital since April 2020, in order to be able to compare them between them and follow their evolution in the medium term. This work could make it possible to describe the specific cognitive impairment of SARS-CoV2, by trying to evade other causes of cognitive disorders in patients hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic disorders, etc.).\n\nThe main objective is to follow the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with the use of ventilatory resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the intensive care unit of the Paris Saint-Joseph Hospital (HPSJ), for the management of their respiratory distress following COVID infection, between April 2020 and April 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient whose age ≥ 18 years\n* Patient with SARS-CoV2 treated in the intensive care unit of the HPSJ for respiratory distress, using invasive ventilation by oro-tracheal intubation from April 2020\n* French speaking patient\n\nExclusion Criteria:\n\n* Patient with an alertness disorder with Glasgow eye score \\<3 and / or motor \\<6 (confusion being a poor criterion for evaluating the Glasgow score apart from head trauma).\n* Patient with impossibility to communicate (mutism, aphonia, major language barrier)\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient objecting to the use of his data for this research'}, 'identificationModule': {'nctId': 'NCT04468035', 'acronym': 'CognitiVID', 'briefTitle': 'Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS on COVID-19 Pneumonia Requiring Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS (Acute Respiratory Distress Syndrome) on SARS-CoV2 Viral Pneumonia Requiring Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'CognitiVID'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Clement Vialatte de Pémille, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}