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

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05935566
• Collaborator: (none)
• Enrollment: 144
• Anticipated Duration (Months): 8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tonsillectomy; COVID-19; Adenoidectomy	Other: health questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 144 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with a history of tonsillectomy or adenoidectomy. [immédiat]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT05935566
• Other Study ID Numbers: 49RC23_0052
• First Posted: Jul 7, 2023
• Last Update Posted: Jul 7, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jul 7, 2023