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NCT04838834 · ClinicalTrials.gov registry record

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

A clinical trial of COVID-19 and Inflammatory Bowel Diseases, sponsored by Connecticut Children's Medical Center.

Completed
Registry status
472
Enrollment target
1
Study location

NCT04838834 is a study of COVID-19 and Inflammatory Bowel Diseases that has completed, run by Connecticut Children's Medical Center. The registered enrollment target is 472 participants, below the 55,212-participant average among 203 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04838834, a study of COVID-19 and Inflammatory Bowel Diseases, has completed, sponsored by Connecticut Children's Medical Center.

COMPLETED
Registry status
472 participants
Enrollment target
1
Study location

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.

Study Locations (1)

Connecticut

  • Connecticut Children's Medical Center - Hartford

Trial Details

FieldValue
Enrollment Target 472 participants
Start Date 2020-05-15
Est. Completion 2025-02-10

What the Registry Record Tells You About NCT04838834

The ClinicalTrials.gov registry entry for NCT04838834 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 472 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,212-participant average among 203 other COVID-19 trials with a reported enrollment target (99% lower). The listed sponsor is Connecticut Children's Medical Center, which has 55 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 0 interventions.

NCT04838834 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT04838834 about?

NCT04838834 is a clinical study titled "Monitoring Serologic Response to Severe Acute Respiratory Syndrome-2 (SARS-COV-2)/COVID-19 in Children". 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, under...

What is the current status of trial NCT04838834?

This trial is currently completed. The enrollment target is 472 participants. The study started on 2020-05-15. Estimated completion is 2025-02-10.

What conditions does trial NCT04838834 study?

This clinical trial studies the following conditions: COVID-19, Inflammatory Bowel Diseases, SARS-CoV-2.

Who is sponsoring clinical trial NCT04838834?

This trial is sponsored by Connecticut Children's Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04838834 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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