Project 422544

The manifestations of COVID-19 in children are not yet well understood, and may be atypical when compared to adults. We propose to carry out a two-year global prospective study that will enroll and follow-up children with suspected COVID-19 from 50 participating emergency departments (ED) across 19 countries. Patient epidemiological and demographic information, clinical characteristics, and disease outcomes, will be collected at the time of ED admission, during the course of illness, and at three weeks and three months after enrollment, using WHO-compliant case report forms. Statistical analysis of the collected data will allow for the identification of risk factors associated with children having confirmed SARS-CoV-2 infection, and/or severe COVID-19 outcomes. In order to enable rapid implementation, this study will be built as a parallel study that borrows the infrastructure from an ongoing study - the called Pediatric Emergency Research Network (PERN)-Pneumonia study, which has ethics approval, a centralized database, data sharing agreements, and established study teams that are actively enrolling children in 70 sites worldwide. Our multidisciplinary team of investigators includes pediatric infectious disease and emergency medicine clinicians, epidemiologists, statisticians, and public health leaders (from PHAC and the CDC), all with extensive experience pertaining directly to the research topic. As data will be shared in real-time with appropriate national and international authorities, this study 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 at high risk of SARS-CoV-2 infection and severe COVID-19 outcomes. Furthermore, the establishment of this global multi-site study will be the first trial of a rapid PERN response to a novel virus, which, applying lessons-learned, can be urgently reactivated for future public health emergencies.