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

Completed

• Conditions: Covid19

• Registration Number: NCT04666207
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-25
• Study First Submitted: 2020-11-08
• Primary Completion: 2020-12-10
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-14
• Study Completion: 2020-12-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• a PCR-positive SARS-CoV-2 test

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2	1 year	Measured by RT-PCR

Secondary Outcome Measures

Name	Time	Method
Parental home testing of saliva and feces is feasible in children	1 year	measured by a questionnaire

Trial Locations

Locations (1)

Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark