NCT05935566

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

July 5, 2023

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a history of tonsillectomy or adenoidectomy.

    immédiat

Interventions

Telephone interview with patient to verify medical history, including tonsillectomy and adenoidectomy.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized at SMIT for severe COVID-19 infection between 01/03/20 and 31/11/21, not previously vaccinated against COVID-19.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 7, 2023

Study Start

March 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share