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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04646525
Other study ID # 2020/480
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date February 1, 2021

Study information

Verified date November 2020
Source Selcuk University
Contact Selcen Celik
Phone +9033222443963
Email etikselcuk@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Since it is known that the tonsil and adenoid tissues that are known as a secondary lymphoid organ, which form the first line of defense, are more active in childhood than adults, especially in the childhood age group, and since it has been scientifically shown that patients diagnosed with COVID-19 infection in the pediatric age group overcome this disease lightly than adults, we aimed to reveal whether the defined tonsil and adenoid tissues are the main factors that protect the children's immune system against COVID-19 infection.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 16 Years
Eligibility Inclusion Criteria: - Patients with COVID-19 infection. - Patients aged between 1-16 years - Patients whose PCR test becomes negative Exclusion Criteria: - Patients with lymphoid tissue malignant disease - Patients with known lung disease - Patients with known systemic disease

Study Design


Intervention

Diagnostic Test:
Physical examination
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.

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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). pii: e20200702. doi: 10.1542/peds.2020-0702. Epub 2020 Mar 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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