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

NCT04838834 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 472

Last updated 2025-04-01

No results posted yet for this study

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

Sponsors & Collaborators

  • The Jackson Laboratory

    collaborator OTHER

  • Food and Drug Administration (FDA)

    collaborator FED

  • Connecticut Children's Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Hyams, MD · Connecticut Children's Medical Ctr

Eligibility

Min Age
2 Years
Max Age
27 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2025-02-10
Completion
2025-02-10

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838834 on ClinicalTrials.gov