Clinical Characteristics and Outcomes of Children Potentially Infected by Severe Acute Respiratory Distress Syndrome (SARS)-CoV-2 Presenting to Pediatric Emergency Departments

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.