Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-03-07 @ 2:28 PM
Study NCT ID:
NCT05935566
Status:
WITHDRAWN
Last Update Posted:
2024-08-16
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073222', 'term': 'Patient Health Questionnaire'}], 'ancestors': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'no control patients, so study not launched without comparator', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with a history of tonsillectomy or adenoidectomy.', 'timeFrame': 'immédiat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tonsillectomy', 'COVID-19', 'Adenoidectomy']}, 'descriptionModule': {'briefSummary': 'Little is known about the impact of tonsillectomy and/or adenoidectomy on the severity and presentation of respiratory infections, let alone COVID-19. Current knowledge of the role of NALT suggests that its absence may be associated with an increased risk of severe disease.\n\nAssessing the impact of tonsillectomy and adenoidectomy on the risk of adverse evolution in COVID-19 would help to better identify patients at risk of adverse evolution, so that they can be rapidly offered appropriate treatment. It would also provide a better understanding of the pathophysiology of this infection.\n\nPrimary objective: to determine whether there is a link between a history of tonsillectomy or adenoidectomy and the risk of severe COVID-19.\n\nPrimary endpoint: proportion of patients with a history of tonsillectomy or adenoidectomy among those hospitalized for severe COVID-19.\n\nThe results of this study will be compared with a data-driven study of Covid patients without severe disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized at SMIT for severe COVID-19 infection between 01/03/20 and 31/11/21, not previously vaccinated against COVID-19.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 to 80\n* Hospitalized in SMIT at CHU d'Angers between 01/03/2020 and 30/11/2021 for severe COVID-19 infection (at least 1 severity criterion)\n\nExclusion Criteria:\n\nLong-term home oxygen therapy prior to COVID-19 infection\n\n* Vaccination against COVID-19 with at least one dose of vaccine received prior to COVID-19 infection Confidential Page 11 of 15\n* Inability to ascertain the presence or absence of a history of tonsillectomy or adenoidectomy\n* Person objecting to participation in research"}, 'identificationModule': {'nctId': 'NCT05935566', 'briefTitle': 'Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study', 'orgStudyIdInfo': {'id': '49RC23_0052'}}, 'armsInterventionsModule': {'interventions': [{'name': 'health questionnaire', 'type': 'OTHER', 'description': 'Telephone interview with patient to verify medical history, including tonsillectomy and adenoidectomy.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}