Trials / Completed
CompletedNCT04666207
Viral Shedding, Symptoms and Exposure of SARS-CoV-2 in Non-hospitalized Children With COVID-19
A Cohort Study of Non-hospitalized SARS-CoV-2 Positive Children in Denmark: Viral Shedding, Symptoms and Exposure
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 0 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | PCR | RT-PCR for SARS-CoV-2 |
Timeline
- Start date
- 2020-05-25
- Primary completion
- 2020-12-10
- Completion
- 2020-12-30
- First posted
- 2020-12-14
- Last updated
- 2021-09-16
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04666207. Inclusion in this directory is not an endorsement.