ClinicalTrials.gg
Status unknownNCT04646525Updated Nov 30, 2020

The Relationship Between Covid-19 Infection in Pediatric Patients and Secondary Lymphoid Organs

An observational study in Covid19, Immune Deficiency and Tonsillitis, sponsored by Selcuk University. Status unknown at 1 site in Turkey. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by Selcuk University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
1 Year to 16 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Covid19
  • Immune Deficiency
  • Tonsillitis
  • Tonsil Hypertrophy
  • Adenoiditis
  • Adenoid Hypertrophy

Keywords

  • pediatric
  • covid19
  • İmmune system
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 300 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Selcuk University is the lead sponsor of 258 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testPhysical 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.

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

06

What researchers measure

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.

    Time frame: 2020-2021

07

Study locations

1 of 1 sites recruiting
  • Selcuk University
    Konya, Selcuklu 42100, Turkey
    Recruiting
08

References and documents

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 32212348 ↗
  • 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. PubMed 32179660 ↗

Individual participant data

Plan to share: Undecided — We plan to share our study data after completing collecting patient data and preparing the article about the study.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2020 (actual). Primary completion is estimated for Feb 2021, 4 months after the start.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 4 months is below that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2020
First posted
Nov 30, 2020
StartActual
Oct 1, 2020
Primary completionEst.
Feb 1, 2021
CompletionEst.
Feb 1, 2021
Last update
Nov 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04646525
Lead sponsor
Selcuk University
Responsible party
Merih Onal (Assistant Professor, Selcuk University) — Principal investigator
First posted
Nov 30, 2020
Start date
Oct 1, 2020
Primary completion
Feb 1, 2021 (estimated)
Completion
Feb 1, 2021 (estimated)
Last update
Nov 30, 2020

Study contacts

Selcen Celik
Contact
etikselcuk@gmail.com
+9033222443963
Merih Onal, Assist. Prof.
principal investigator · Selcuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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