Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04853316 |
| Other study ID # |
REB20-0609 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 31, 2021 |
| Est. completion date |
August 22, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
University of Calgary |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
of COVID-19 pandemic control1. While pediatric SARS-CoV-2 infection is yet to be fully
characterized, and generally children are more likely to experience asymptomatic
infection or mild disease compared with adults, severe outcomes are possible. Although
person-to-person spread is well described in children, as schools have been closed, the
transmission risk in that environment remains unknown. More importantly, the
contribution of pre/asymptomatic children to overall transmission of SARS-CoV-2 is
unclear with most pediatric cases linked to a symptomatic household member. According to
China's National Health Commission, 130 (78%) of 166 new infections identified on April
1, 2020 were asymptomatic. In addition, data from an adult long-term care facility in
Washington indicates that symptom-based screening failed to identify a significant
proportion of COVID-19 cases. Furthermore, based on RT-PCR cycle threshold values, large
quantities of viral RNA were detected in pre/asymptomatic residents, suggesting the
potential for transmission regardless of symptoms. Asymptomatic pediatric colonization,
while reported, is poorly described.
Rationale: SARS-CoV-2 shedding has been noted to occur in minimally symptomatic and
asymptomatic infected persons. Children therefore, who appear to more commonly
experience mild and asymptomatic infection, may represent a significant risk of
household and community transmission. Recommendations for school closures are currently
based on assumptions as well as evidence gathered from influenza outbreaks where these
measures are known to reduce social contacts and interrupt transmission. School
closures, however, disrupt the lives of students and their families and may have
negative consequences on child health16. Moreover, COVID-19 transmission modelling
studies predict that school closures alone prevent only 2 - 4% of COVID-19-related
deaths in the general population, much less than other physical distancing
interventions. It should be noted that as school closures were in place before
observational studies could begin, the secondary clinical attack rate of
pre/asymptomatic children is unknown.
2. Research Questions & Objectives:
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 by determining the following:
If the proportion of household members who develop symptomatic illness over the
subsequent 12 days is greater among households of pre/asymptomatic SARS-CoV-2 positive
children relative to negative children. Mathematical models will be developed to
understand the risks associated with other community transmission settings.
In SARS-CoV-2 positive children, if quantitative viral loads differ between those who
become symptomatic relative to those who remain asymptomatic and have secondary
household cases.
Secondary aims of this study include the following:
Determining risk factors for SARS-CoV-2 pre/asymptomatic infection in children.
3. Study Design and Methods:
A prospective cohort study, taking place at multiple institutions throughout the United
States and Canada, of children brought to the Emergency Department for care due to a
condition or illness unrelated to SARS-CoV-2 infection who are tested as part of ongoing
local asymptomatic surveillance programs.
For every SARS-CoV-2-positive asymptomatic child enrolled, three asymptomatic SARS-CoV-2-test
negative children will also be recruited.
Any child that is tested for the presence of SARS-CoV-2 who is asymptomatic as part of
clinical care, will be potentially eligible for the study. Locally, any child who is tested
for the presence of SARS-CoV-2 and who is not displaying any known COVID-19 symptoms will be
asked by an Alberta Health Services ED staff member for consent to provide their information
to the research team to be contacted about potential participation in the study (consent to
contact). Due to testing result timelines and to minimize possible exposure, informed
consent/assent will be obtained via telephone and a copy of the consent documentation will be
sent via email to the consenting individual, if required. Eligibility for the study based on
inclusion and exclusion criteria will be determined over the telephone. Data will be obtained
from the participant, their caregiver, and their medical chart, as appropriate. To obtain
data related to symptomology, additional medical care, additional testing, and household
transmission, a follow up questionnaire will be performed 14 days after the baseline ED
visit. If a member of the household is waiting on SARS-CoV-2 testing results at the 14 day
follow up time point, an additional call will be made 21 days after the baseline ED visit to
obtain SARS-CoV-2 test results. A follow-up call will be performed at 90 days to identify any
chronic symptoms that may have developed.
