NCT04646525

Brief Summary

We aimed to find out whether the tonsils and nasal tissues of pediatric patients are the main factors that protects the children's immune system against COVID-19 infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 5, 2020

Last Update Submit

November 26, 2020

Conditions

Keywords

pediatriccovid19İmmune system

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of our study was the evaluation of pediatric patients diagnosed with COVID-19 and who had COVID-19 infection in terms of adenoid and tonsillar tissue hypertrophy and the presence of chronic or recurrent infection.

    The structure of the tonsil and adenoid tissues will be examined by physical examination, and the presence of tonsil and adenoid hypertrophy, tonsillitis, and adenoiditis conditions will be identified. The severity of covid-19 will be determined according to the cases of patients with tonsil and adenoid tissue disorders, who are hospitalized in intensive care, have infiltration in the lungs, and receive oxygen support.

    2020-2021

Interventions

Physical examinationDIAGNOSTIC_TEST

Pediatric patients diagnosed with COVID-19 and who have had infection will be examined, adenoid and tonsillar tissues will be evaluated in terms of hypertrophy, chronic, or recurrent infection.

Also known as: Only the tonsil and adenoid tissues of the patients will be examined by physical examination, no intervention will be done

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients between the ages of 1-16 diagnosed with Covid-19 will be examined by the ENT doctor in terms of tonsil and adenoid tissues after they overcome the active infection period and PCR tests turn negative.

You may qualify if:

  • Patients with COVID-19 infection.
  • Patients aged between 1-16 years
  • Patients whose PCR test becomes negative

You may not qualify if:

  • Patients with lymphoid tissue malignant disease
  • Patients with known lung disease
  • Patients with known systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Brodin P. Why is COVID-19 so mild in children? Acta Paediatr. 2020 Jun;109(6):1082-1083. doi: 10.1111/apa.15271. Epub 2020 Apr 15. No abstract available.

    PMID: 32212348BACKGROUND
  • Dong Y, Mo X, Hu Y, Qi X, Jiang F, Jiang Z, Tong S. Epidemiology of COVID-19 Among Children in China. Pediatrics. 2020 Jun;145(6):e20200702. doi: 10.1542/peds.2020-0702. Epub 2020 Mar 16.

    PMID: 32179660BACKGROUND

MeSH Terms

Conditions

COVID-19Immunologic Deficiency SyndromesTonsillitis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesImmune System DiseasesPharyngitisPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Merih Onal, Assist. Prof.

    Selcuk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 30, 2020

Study Start

October 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations