Asymptomatic SARS-CoV-2 Detection in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04853316|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2021
Last Update Posted : May 18, 2022
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||372 participants|
|Official Title:||Household Transmission Dynamics and Viral Load Among Asymptomatic SARS-CoV-2 Infected Children|
|Actual Study Start Date :||November 16, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
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.
- Symptoms of COVID-19 in household members of participating children in the subsequent 14 days following enrollment [ Time Frame: 14 days ]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.
- Viral Load of SARS-CoV-2 in positive children [ Time Frame: 14 days ]The difference in typical viral loads between children of different symptom and case statuses, as well as those with and without clinical secondary cases.
- Presence of epidemiological risk factors for SARS-CoV-2 infection [ Time Frame: 14 days ]Risk factors such as exposures, travel, following public health policy. The frequency of such risk factors among participating children will allow for calculation of the relative risk of such factors.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853316
|United States, Alabama|
|Children's of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|University of California, San Diego - Rady Children's Hospital|
|San Diego, California, United States, 92123|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|Children's Medical Center of Dallas - UT Southwestern|
|Dallas, Texas, United States, 75235|
|Alberta Children's Hospital|
|Calgary, Alberta, Canada, T3B 6A8|
|Principal Investigator:||Stephen Freedman, MD||University of Calgary|