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

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

Detailed Description

Not Provided

Active, not recruiting
COVID-19
SARS-CoV-2
Inflammatory Bowel Diseases
Eligibility Criteria

Inclusion Criteria:

1. Patients aged 2 to 27 years inclusive

2. Patients receiving biologic infusions for inflammatory or rheumatologic disorders at
the Connecticut Children's Infusion Center, at a minimum frequency of 2 infusions
over a 4 month period

3. Consent/assent as indicated

4. Have vein access placement as standard of care

Exclusion Criteria:

1. Patient and/or parent/legal guardian refused participation

2. Inability to draw requisite blood sample for serum collection

Eligibility Gender
All
Eligibility Age
Minimum: 2 Years ~ Maximum: 27 Years
Countries
United States
Locations

Connecticut Children's Medical Center
Hartford, Connecticut, United States

Jeffrey Hyams, MD, Principal Investigator
Connecticut Children's Medical Ctr

Connecticut Children's Medical Center
NCT Number
Keywords
COVID-19 Serological Testing
MeSH Terms
COVID-19
Inflammatory Bowel Diseases