This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations.
What Does the Study Involve?
This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics of the immune response to SARS-CoV-2, genetic factors associated with long-term outcomes, and the extent and duration of protective immunity.
Who Can Participate?
Participants aged 3 to 21 years with confirmed history of symptomatic SARS CoV-2 infection (including COVID-19), MIS C, or asymptomatic SARS CoV-2 infection (n = up to 1000), as well as healthy contacts (aged ≤21 years; n = up to 1000). Additionally, a parent or guardian of each participant will be enrolled to complete targeted questionnaires (n = up to 2000).
Where Is It Taking Place?
National Institutes of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland United States 20852
Is There a Cost?
Is Compensation Provided?
The total amount for completion of all scheduled study visits will be $320 for survivors in the recovery group, $280 for survivors in the convalescent group, and $160 for household contact participants.
Number of Visits Required:
Recovery Group: 8 visits
Convalescent Group: 6 visits
Healthy Contact: 4 visits
Steps to Participate:
Fill out our interest form on the Formstack website - https://childrensnational.formstack.com/forms/covid_misc_study
Visit ClinicalTrials.gov for details.
Gina A. Montealegre Sanchez, MD, MS; Karyl Barron, MD; Roberta DeBiasi, MD