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NCT05935566 Clinical Trial

Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study

COVID-19 Clinical Trial

Official title:
Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05935566
Other study ID # 49RC23_0052
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2023
Est. completion date March 2024

Study information
Verified date June 2023
Source University Hospital, Angers
Contact Vincent Dubée, Pr
Phone 02 41 35 39 30
Email Vincent.Dubee@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. Assessing 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. Primary objective: to determine whether there is a link between a history of tonsillectomy or adenoidectomy and the risk of severe COVID-19. Primary endpoint: proportion of patients with a history of tonsillectomy or adenoidectomy among those hospitalized for severe COVID-19. The results of this study will be compared with a data-driven study of Covid patients without severe disease.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 144
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adults aged 18 to 80 - 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) Exclusion Criteria: Long-term home oxygen therapy prior to COVID-19 infection - Vaccination against COVID-19 with at least one dose of vaccine received prior to COVID-19 infection Confidential Page 11 of 15 - Inability to ascertain the presence or absence of a history of tonsillectomy or adenoidectomy - Person objecting to participation in research

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• health questionnaire
Telephone interview with patient to verify medical history, including tonsillectomy and adenoidectomy.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with a history of tonsillectomy or adenoidectomy. immédiat
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