Covid19NCT04646525
The Relationship Between Covid-19 Infection in Pediatric Patients and Secondary Lymphoid Organs
An observational study of Covid19 and Immune Deficiency, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Covid19, Immune Deficiency, Tonsillitis
- What is being tested?
- Physical examination
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Feb 2021
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Patients with COVID-19 infection.
- Patients aged between 1-16 years
- Patients whose PCR test becomes negative
Who cannot join
- Patients with lymphoid tissue malignant disease
- Patients with known lung disease
- Patients with known systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selcuk University
Konya, Selcuklu, 42100
Selcen Celik, etikselcuk@gmail.com
Merih Onal, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Immune Deficiency, Tonsillitis, Tonsil Hypertrophy, Adenoiditis, Adenoid Hypertrophy
- Being tested
- Physical examination
- Keywords
- pediatric, covid19, İmmune system
- Medical subject headings
- COVID-19, Immunologic Deficiency Syndromes, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examinationDiagnostic test
Also called Only the tonsil and adenoid tissues of the patients will be examined by physical examination, no intervention will be done
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Oct 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Onal, Selcuk University
- Investigators
- Merih Onal, Assist. Prof., Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646525
- Sponsor's protocol ID
- 2020/480
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share our study data after completing collecting patient data and preparing the article about the study.
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.
PubMed 32212348Dong 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.
PubMed 32179660
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Mild Covid-19 Infection in Pediatric Patients and Protection of Secondary Lymphoid Organs
- ClinicalTrials.gov ID
- NCT04646525
- Acronym / sponsor ID
- 2020/480
- Conditions
- Covid19, Immune Deficiency, Tonsillitis, Tonsil Hypertrophy, Adenoiditis, Adenoid Hypertrophy
- Keywords
- pediatric, covid19, İmmune system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 30 Nov 2020 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Patients with COVID-19 infection.
- Patients aged between 1-16 years
- Patients whose PCR test becomes negative
Key exclusion criteria (3 listed)
- Patients with lymphoid tissue malignant disease
- Patients with known lung disease
- Patients with known systemic disease
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 |
|---|---|---|
| Physical examinationAlso: Only the tonsil and adenoid tissues of the patients will be examined by physical examination, no intervention will be donePediatric 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 32212348Brodin 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.
- Background: PubMed 32179660Dong 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.
- Individual participant dataSharing planned: Undecided. We plan to share our study data after completing collecting patient data and preparing the article about the study.
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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.
Merih Onal, Assist. Prof. principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Immune Deficiency, run by Selcuk University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selcen Celik (+9033222443963, etikselcuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646525, which also lists 2 linked publications.
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 30 Nov 2020.