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

NCT04666207 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

PCR

RT-PCR for SARS-CoV-2

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Ulrikka Nygaard, MD, PhD · Rigshospitalet, Denmark

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2020-12-10
Completion
2020-12-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04666207 on ClinicalTrials.gov