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Viral Shedding, Symptoms and Exposure of SARS-CoV-2 in Non-hospitalized Children With COVID-19

A Cohort Study of Non-hospitalized SARS-CoV-2 Positive Children in Denmark: Viral Shedding, Symptoms and Exposure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04666207
Enrollment
24
Registered
2020-12-14
Start date
2020-05-25
Completion date
2020-12-30
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

Data on COVID-19 in children are still scarce, and their role in SARS-CoV-2 transmission is poorly described. Furthermore, documentation of the best SARS-CoV-2 sampling methods in children are limited. In adults, saliva seems like a promising specimen to collect by noninvasive procedure to diagnose and monitor viral load of SARS-CoV-2, but this has not been tested in children yet. We want to test the following hypothesis: 1. Shedding load and duration of SARS-CoV-2 in children are related to age, gender, clinical symptoms and exposure 2. Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2 3. Parental home testing of saliva and feces is feasible in children The study is a prospective cohort study of SARS-CoV-2 PCR-positive children from two test centers in the Capital Region of Denmark. Children aged 0-17 years with a PCR-positive SARS-CoV-2 test from a nasal or pharyngeal swab is included from May 2020 to January 2021 and followed-up for a period of 28 days with weekly sample collection and questionnaires. Samples include a saliva sample, a nasal swap and a rectal swap for children under four years of age. A semiquantitative RT-PCR method, will identify positive and negative samples and provide a Ct value estimating viral load. Saliva and fecal samples will be analyzed from November 2020-February 2021. Shedding duration will be related to medial history, clinical presentation, exposure, gender and age.

Interventions

DIAGNOSTIC_TESTPCR

RT-PCR for SARS-CoV-2

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* a PCR-positive SARS-CoV-2 test

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-21 yearMeasured by RT-PCR

Secondary

MeasureTime frameDescription
Parental home testing of saliva and feces is feasible in children1 yearmeasured by a questionnaire

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026