Status:
COMPLETED
Asymptomatic SARS-CoV-2 Detection in Children
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Covid19
SARS-CoV-2
Eligibility:
All Genders
Up to 18 years
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.
Detailed Description
1. Background \& Rationale: Background: Transmission from individuals with pre-symptomatic and asymptomatic (hereafter abbreviated as pre/asymptomatic) SARS-CoV-2 infections is the Achilles' heel ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT04853316
Start Date
January 31 2021
End Date
August 22 2022
Last Update
November 2 2022
Active Locations (5)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
University of California, San Diego - Rady Children's Hospital
San Diego, California, United States, 92123
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
Children's Medical Center of Dallas - UT Southwestern
Dallas, Texas, United States, 75235