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

September 15, 2021 updated by: Allan Bybeck Nielsen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Copenhagen University Hospital Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SARS-CoV-2 PCR-positive children from two test centers in the Capital Region of Denmark

Description

Inclusion Criteria:

  • a PCR-positive SARS-CoV-2 test

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental home testing of saliva and feces is feasible in children
Time Frame: 1 year
measured by a questionnaire
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Ulrikka Nygaard, MD, PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Actual)

December 10, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20028631-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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