NCT04666207

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. 1.Shedding load and duration of SARS-CoV-2 in children are related to age, gender, clinical symptoms and exposure
  2. 2.Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2
  3. 3.Parental home testing of saliva and feces is feasible in children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

November 8, 2020

Last Update Submit

September 15, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

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

    Measured by RT-PCR

    1 year

Secondary Outcomes (1)

  • Parental home testing of saliva and feces is feasible in children

    1 year

Interventions

PCRDIAGNOSTIC_TEST

RT-PCR for SARS-CoV-2

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • a PCR-positive SARS-CoV-2 test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

feces, saliva, nasal secretions

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ulrikka Nygaard, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 8, 2020

First Posted

December 14, 2020

Study Start

May 25, 2020

Primary Completion

December 10, 2020

Study Completion

December 30, 2020

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)