Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population. Goals: Primary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children. Secondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes. Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days. Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements. Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.
Pediatric COVID-19: The characteristics of pediatric 2019 novel coronavirus disease
(COVID-19) are not yet well understood. Preliminary findings indicate that atypical
presentations of COVID-19 occur in children. Thus, there is an urgent need to identify risk
factors for pediatric COVID-19 infection, the range of clinical manifestations, predictors of
severe outcomes, and successful treatment strategies.
Objectives: Primary: To contribute to the optimization of medical countermeasures to
pediatric COVID-19 through describing and comparing the clinical characteristics of
SARS-CoV-2 infected children (i.e. test positive) with children who were screened for
SARS-CoV-2 but tested negative. We will also describe and compare SARS-CoV-2 infected
children with mild versus those with severe outcomes. This study will also describe the
health care resources utilized for screening, isolation, and care of pediatric COVID-19,
examined alongside relevant public health policies.
Methods: This is a two-year prospective observational study that will take place at 50 EDs
across 19 countries. We will enroll children (<18 years old) presenting to participating
study EDs who meet institutional screening guidelines and undergo testing for COVID-19. Data
collection is aligned with WHO templates and focuses on epidemiological factors,
demographics, signs, symptoms, exposures, interventions, and test results. Collection will
occur at the time of enrolment, during the course of illness, at hospital discharge (if
admitted), and at two weeks and three months following enrolment. Over a period of 18 months
(starting March 31st, 2020) we aim to enroll and complete follow-up for a total of 5000
children with screened for suspected SARS-CoV-2 infection. Data will be entered into a
centralized database, and analyzed using simple and multiple ordinal logistic regression
models. Data will be interpreted alongside detailed, prospectively collected, information on
the changes to case isolation, screening, and management policies that occur throughout the
epidemic in each institution and study region.
Feasibility: The Pediatric Emergency Research Networks (PERN) represents the largest
international acute pediatric care collaboration in the world, including more than 200
hospitals across 35 countries. Currently, PERN is carrying out the PERN-Pneumonia prospective
cohort study, designed to identify predictors of severe pneumonia at 70 hospitals around the
globe, including at eight Canadian pediatric emergency departments (ED). This study will
build onto the PERN-Pneumonia study infrastructure (e.g. ethics approvals, data sharing
agreements, research teams) in order to facilitate a unique, rapid, and global response to
the COVID-19 epidemic. Feasibility is enhanced by our design - we will not interfere with the
existing COVID-19 screening and management procedures in-place in study EDs; we will not
collect any biological specimens, and will not prescribe any interventions.
Project Team: This international multidisciplinary team includes pediatric emergency medicine
and infectious disease clinicians, epidemiologists, statisticians, and public health leaders
from around the globe. Team members have led many landmark trials in pediatric emergency
medicine, and lead large pediatric research networks and studies including the PERN-Pneumonia
study. They also came together to study the H1N1 pandemic and identified predictors of severe
outcomes. Team members also have expertise in pediatric lower respiratory tract infections,
biostatistics, and epidemiology (including the CDC lead on the MERS-CoV outbreak). This study
team also includes the Public Health Agency of Canada's senior medical/technical expert on
COVID-19.
Impact of the research: The results of this study, which will be shared in real-time with
appropriate national and international authorities, will enable policymakers to make rapid
evidence-based adaptations to case screening and management procedures that will then allow
for the earlier identification of children likely to have confirmed infection with COVID-19
as well as to prioritize those children likely to have severe outcomes. Finally, the
establishment of this global multi-site study will be the first trial of a rapid PERN
networks response to a pandemic novel respiratory virus, which, applying lessons-learned, can
be urgently reactivated for future public health emergencies.
Other: Exposure (not intervention) - SARS-CoV-2 infection
Exposure is infection with the virus. There is no intervention
Inclusion Criteria:
1. < 18 years-old, and
2. Present to a participating ED for care, and
3. Undergo SARS-CoV-2 testing.
Exclusion Criteria:
1) Refusal to participate (no informed consent)
University of Calgary/Alberta Children's Hospital
Calgary, Alberta, Canada
Stephen Freedman, MD, Principal Investigator
University of Calgary