NCT04853316

Brief Summary

The primary objective of this study is quantify the transmission risk posted by SARS-CoV-2 in pre/asymptomatic infected children in order to inform the public health response to the COVID-19 pandemic.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
2 countries

5 active sites

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

January 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

November 2, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

April 16, 2021

Last Update Submit

November 1, 2022

Conditions

Covid19SARS-CoV-2

Keywords

COVID19Household transmissionPediatricsAsymptomaticPublic health

Outcome Measures

Primary Outcomes (1)

  • Symptoms of COVID-19 in household members of participating children in the subsequent 14 days following enrollment

    The clinical secondary attack rate (SAR) for households of participating children, which will be compared to generate the relative SAR for households of children with varying case and symptom statuses.

    14 days

Secondary Outcomes (1)

  • Viral Load of SARS-CoV-2 in positive children

    14 days

Other Outcomes (1)

  • Presence of epidemiological risk factors for SARS-CoV-2 infection

    14 days

Study Arms (2)

Case: Exposed (SARS-CoV-2 positive)

Participants found positive by SARS-CoV-2 testing.

Control: Unexposed (SARS-CoV-2 negative)

Participants found negative by SARS-CoV-2 testing.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children younger than 18 years of age presenting to a participating ED who meet institutional surveillance screening guidelines (i.e. present with a non-infectious, non-viral concern) and undergo SARS-CoV-2 testing. The number of children eligible may vary based on evolving SARS-CoV-2 testing procedures, public health policy, and patient volumes.

You may qualify if:

  • Younger than 18 years of age
  • Had SARS-CoV-2 NAT testing performed during the ED visit as part of an ongoing active asymptomatic surveillance program:
  • Exposed (SARS-CoV-2 positive) specific: Was found positive by SARS-CoV-2 NAT testing in the ongoing active surveillance program
  • Unexposed (SARS-CoV-2 negative/control) specific: Was found negative by SARS-CoV-2 NAT testing in the ongoing active surveillance program

You may not qualify if:

  • Presence of any of the following viral symptoms commonly associated with SARS-CoV- 2 infection: fever, cough, dyspnea/difficulty breathing, generalized fatigue/weakness, myalgia (muscle or body aches), chills, feeling very unwell, sore throat, runny nose, gastrointestinal symptoms (vomiting, diarrhea), conjunctivitis, headache, anosmia (loss of smell), ageusia (loss of taste) or rash in the 24 hours preceding the index visit (when the child was tested for the presence of SARS-CoV-2).
  • Previously diagnosed with SARS-CoV-2 infection based on a positive swab or serology (blood) test.
  • Decline to provide informed consent and/or assent, as required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

University of California, San Diego - Rady Children's Hospital

San Diego, California, 92123, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Medical Center of Dallas - UT Southwestern

Dallas, Texas, 75235, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

SARS-CoV-2 Testing will be performed according to local public health and institutional guidelines. For any participants who tested positive for the presence of SARS-CoV-2, an aliquot of the corresponding positive test will be obtained. Viral load quantification will be performed on any specimens obtained.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stephen Freedman, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

January 31, 2021

Primary Completion

April 22, 2022

Study Completion

August 22, 2022

Last Updated

November 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(4)