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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853316
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Calgary

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.

Condition or disease
Covid19 SARS-CoV-2

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Case-Control
Time Perspective: Prospective
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, 2021
Estimated Study Completion Date : June 1, 2022

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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
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.


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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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:

    1. Exposed (SARS-CoV-2 positive) specific: Was found positive by SARS-CoV-2 NAT testing in the ongoing active surveillance program
    2. Unexposed (SARS-CoV-2 negative/control) specific: Was found negative by SARS-CoV-2 NAT testing in the ongoing active surveillance program

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Alissa Kazakoff, BSc 403-955-3197 akazakof@ucalgary.ca
Contact: Sarah Williamson-Urquhart, BScKIN 4039552482 sarah.urquhart@ahs.ca

Locations
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United States, Alabama
Children's of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Nipam Shah, MBBS, MPH       nshah@peds.uab.edu   
Sub-Investigator: Nipam Shah, MBBS, MPH         
United States, California
University of California, San Diego - Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Mike Gardiner, MD       magardiner@health.ucsd.edu   
Sub-Investigator: Mike Gardiner, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mark Neuman, MD, MPH       mark.neuman@childrens.harvard.edu   
Sub-Investigator: Mark Neuman, MD         
United States, Texas
Children's Medical Center of Dallas - UT Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Mike Baldovsky, DO       Mike.Baldovsky@UTSouthwestern.edu   
Sub-Investigator: Mike Baldovsky, DO         
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Alissa Kazakoff    403-955-3197    akazakof@ucalgary.ca   
Principal Investigator: Anna Funk         
Principal Investigator: Stephen Freedman         
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Stephen Freedman, MD University of Calgary
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04853316    
Other Study ID Numbers: REB20-0609
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
COVID19
Household transmission
Pediatrics
Asymptomatic
Public health