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

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Rigshospitalet

Status

Completed

Conditions

Covid19

Treatments

Diagnostic Test: PCR

Study type

Observational

Funder types

Other

Identifiers

NCT04666207
H-20028631-1

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • a PCR-positive SARS-CoV-2 test

Exclusion criteria

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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