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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05935566
Recruitment Status : Not yet recruiting
First Posted : July 7, 2023
Last Update Posted : July 7, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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
Tonsillectomy COVID-19 Adenoidectomy Other: health questionnaire

Study Design
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Study Type : Observational
Estimated 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
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with a history of tonsillectomy or adenoidectomy. [ Time Frame: immédiat ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05935566


Contacts
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Contact: Vincent Dubée, Pr 02 41 35 39 30 Vincent.Dubee@chu-angers.fr
Contact: DRCI Promotion Interne DRCI-Promotion-Interne@chu-angers.fr

Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT05935566    
Other Study ID Numbers: 49RC23_0052
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases