NCT04838834

Monitoring Serologic Response to Severe Acute Respiratory Syndrome-2 (SARS-COV-2)/COVID-19 in Children

Monitoring Serologic Response to SARS-COV-2 / Coronavirus Disease 2019 (COVID-19) in Children, Adolescents, and Young Adults Receiving Biologic Therapies (RECONN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 472 (actual)
• Sponsor: Connecticut Children's Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 27 Years
• Healthy volunteers: Not accepted

Summary

Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. Whether children and young adults with inflammatory bowel disease (IBD) or juvenile idiopathic arthritis (JIA) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from COVID-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (MISC), is entirely unclear. This research focuses on the heretofore uncharacterized immune response to SARS-CoV-2 infection in children and young adults with IBD or JIA who are receiving maintenance immunosuppressive biologic therapies. Given the large Connecticut based infusion program, in a region of the United States with a recent large outbreak of COVID-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. The investigators will longitudinally determine antibody development and durability to SARS-CoV-2 in approximately 450-500 children and young adults with IBD or JIA receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. This period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-SARS CoV-2 vaccines. The specific aim is to study the acute and convalescent antibody responses to SARS-CoV-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for IBD and JIA.

Conditions

• COVID-19
• SARS-CoV-2
• Inflammatory Bowel Diseases

Timeline

• Start date: 2020-05-15
• Primary completion: 2025-02-10
• Completion: 2025-02-10
• First posted: 2021-04-09
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States