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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: Completed study of COVID-19 and Inflammatory Bowel Diseases, sponsored by Connecticut Children's Medical Center.
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 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
Study Locations (1)
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 472 participants |
| Start Date | 2020-05-15 |
| Est. Completion | 2025-02-10 |
What the finished NCT04838834 record still lists
NCT04838834 is an observational study that tracks outcomes without assigning an intervention. The registered 472 participants enrollment target is mid-sized for trials with a published cap, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 0 interventions.
NCT04838834 reports a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04838834's enrollment target sits among peer trials
472 116th of 298 higher than 183 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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