COVID-19, Inflammatory Bowel Diseases, SARS-CoV-2
Conditions
Keywords
COVID-19 Serological Testing
Brief 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.
Interventions
None listed
Sponsors
Connecticut Children's Medical Center
The Jackson Laboratory
Food and Drug Administration (FDA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 27 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of anti-SARS-CoV-2 Immunoglobulin G (IgG) | At the time of infusions for up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Presence of anti-SARS-CoV-2 IgG neutralizing antibodies | At the time of infusions for up to 2 years |
Countries
United States
Outcome results
None listed