TonsillectomyNCT05935566
Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study
An observational study of Tonsillectomy and COVID-19, run by University Hospital, Angers.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tonsillectomy, COVID-19, Adenoidectomy
- What is being tested?
- health questionnaire
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
Read more
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.
- Conditions
- Tonsillectomy, COVID-19, Adenoidectomy
- Being tested
- health questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health questionnaireOther
Telephone interview with patient to verify medical history, including tonsillectomy and adenoidectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a history of tonsillectomy or adenoidectomy.
Measured: immédiat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: no control patients, so study not launched without comparator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935566
- Sponsor's protocol ID
- 49RC23_0052
- Status last verified
- Aug 2024
- First submitted
- 5 Jul 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study
- ClinicalTrials.gov ID
- NCT05935566
- Acronym / sponsor ID
- 49RC23_0052
- Conditions
- Tonsillectomy, COVID-19, Adenoidectomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no control patients, so study not launched without comparator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health questionnaireTelephone interview with patient to verify medical history, including tonsillectomy and adenoidectomy. | Other | – |
Primary outcome
Proportion of patients with a history of tonsillectomy or adenoidectomy.
Time frame: immédiat
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillectomy and COVID-19, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a history of tonsillectomy or adenoidectomy. (time frame: immédiat). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.