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OpenTrials
Completed

NCT Number: NCT04666207

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

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.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a PCR-positive SARS-CoV-2 test

Exclusion criteria

-

Treatment and study plan

PCR

Diagnostic Test

RT-PCR for SARS-CoV-2

Primary outcomes

  1. Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2

    Time frame: 1 year

    Measured by RT-PCR

Secondary outcomes

  1. Parental home testing of saliva and feces is feasible in children

    Time frame: 1 year

    measured by a questionnaire

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2020
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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