Clinical trial NCT04838834: Monitoring Serologic Response to Severe Acute Respiratory Syndrome-2 (SARS-COV-2)/COVID-19 in Children
Official title: Monitoring Serologic Response to SARS-COV-2 / Coronavirus Disease 2019 (COVID-19) in Children, Adolescents, and Young Adults Receiving Biologic Therapies (RECONN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2
Inflammatory Bowel Diseases
Keywords: COVID-19 Serological Testing
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: The Jackson Laboratory
name: Food and Drug Administration (FDA)
First posted: 2021-04-09
Enrollment: 472
Sex: ALL
Minimum age (years): 2
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults with inflammatory bowel disease or juvenile idiopathic arthritis receiving treatment with biologic agents at Connecticut Children's Infusion Center

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.


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

Primary outcomes:
measure: Presence of anti-SARS-CoV-2 Immunoglobulin G (IgG)
timeFrame: At the time of infusions for up to 2 years
Secondary outcomes:
measure: Presence of anti-SARS-CoV-2 IgG neutralizing antibodies
timeFrame: At the time of infusions for up to 2 years
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Ctr
name: Jeffrey Hyams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neurath MF. COVID-19 and immunomodulation in IBD. Gut. 2020 Jul;69(7):1335-1342. doi: 10.1136/gutjnl-2020-321269. Epub 2020 Apr 17.
citation: Brenner EJ, Ungaro RC, Gearry RB, Kaplan GG, Kissous-Hunt M, Lewis JD, Ng SC, Rahier JF, Reinisch W, Ruemmele FM, Steinwurz F, Underwood FE, Zhang X, Colombel JF, Kappelman MD. Corticosteroids, But Not TNF Antagonists, Are Associated With Adverse COVID-19 Outcomes in Patients With Inflammatory Bowel Diseases: Results From an International Registry. Gastroenterology. 2020 Aug;159(2):481-491.e3. doi: 10.1053/j.gastro.2020.05.032. Epub 2020 May 18.
citation: Brenner EJ, Pigneur B, Focht G, Zhang X, Ungaro RC, Colombel JF, Turner D, Kappelman MD, Ruemmele FM. Benign Evolution of SARS-Cov2 Infections in Children With Inflammatory Bowel Disease: Results From Two International Databases. Clin Gastroenterol Hepatol. 2021 Feb;19(2):394-396.e5. doi: 10.1016/j.cgh.2020.10.010. Epub 2020 Oct 12.
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