The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study

Abstract

Background Data regarding the kinetics of anti–SARS-CoV-2 antibodies and information about post–COVID-19 condition (colloquially known as “long COVID”) in children are scarce, especially in low-income countries. Even though cases of COVID-19 in children are less prevalent than adults, post–COVID-19 condition cases in children are high and have a burden that may impact their growth and development. There are other features of antibody kinetics in connection with SARS-CoV-2 infection that are yet unknown as of this writing, especially in children following infection. Furthermore, the long-term results, risk factors, and underlying pathophysiology are still uncertain. To better understand post–COVID-19 condition in children, it is necessary to further investigate the impact of clinically significant factors such multisystem inflammatory syndrome and disease severity among hospitalized survivors through their SARS-CoV-2 antibody response. Objective We aim to analyze anti–receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies over time and characterize the signs and symptoms of post–COVID-19 condition in pediatric patients at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. Methods This is a longitudinal observational study in Indonesia. Pediatric patients diagnosed with COVID-19 by positive molecular assay using nasopharyngeal swab will be tested for anti–SARS-CoV-2 antibodies using the Roche Elecsys Anti-SARS-CoV-2 S assay at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. Antibody titer data will be reported as means and SDs. The respondents’ signs and symptoms will be observed up to 6 months after the onset of infection, including the vaccination event, reinfection, rehospitalization, and mortality. The clinical features will be reported as frequencies and percentages. Results Participant enrollment began in February 2022. As of September 30, 2022, a total of 58 patients were enrolled. After data collection, results are expected to be analyzed in August 2023. Conclusions This study will allow us to know the kinetics of anti–receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies and data regarding post–COVID-19 condition up to 6 months following infection in the Indonesian pediatric population. Furthermore, this study has the potential to serve as a foundation for government decisions about vaccination programs and prevention measures. International Registered Report Identifier (IRRID) DERR1-10.2196/43344