- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646525
The Relationship Between Covid-19 Infection in Pediatric Patients and Secondary Lymphoid Organs
November 26, 2020 updated by: Merih Onal, Selcuk University
The Relationship Between Mild Covid-19 Infection in Pediatric Patients and Protection of Secondary Lymphoid Organs
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.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Selcen Celik
- Phone Number: +9033222443963
- Email: etikselcuk@gmail.com
Study Locations
-
-
Selcuklu
-
Konya, Selcuklu, Turkey, 42100
- Recruiting
- Selcuk University
-
Contact:
- Selcen Celik
- Email: etikselcuk@gmail.com
-
Principal Investigator:
- Merih Onal, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 2020-2021
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merih Onal, Assist. Prof., Selcuk University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
November 5, 2020
First Submitted That Met QC Criteria
November 26, 2020
First Posted (Actual)
November 30, 2020
Study Record Updates
Last Update Posted (Actual)
November 30, 2020
Last Update Submitted That Met QC Criteria
November 26, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Pathological Conditions, Anatomical
- Pharyngitis
- COVID-19
- Immunologic Deficiency Syndromes
- Hypertrophy
- Tonsillitis
Other Study ID Numbers
- 2020/480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We plan to share our study data after completing collecting patient data and preparing the article about the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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