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NCT04410484 Clinical Trial

PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic

Inflammatory Bowel Diseases Clinical Trial

— PREPARE IBD  

Official title:
PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04410484
Other study ID # 284920
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 22, 2020
Est. completion date August 31, 2022

Study information
Verified date November 2022
Source Hull University Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease

Description:

An observational, retrospective, case-controlled study to determine the status of IBD during development of COVID-19 symptoms/positive COVID-19. The aim is to describe the adaptations in therapies for active IBD during SARS COV 2 in patients with active IBD and positive or negative COVID-19 symptoms. It will evaluate IBD outcomes following development of COVID-19 symptoms / positive COVID-19 and determine any predictors of outcomes in IBD patients with COVID-19 symptoms / positive COVID-19 as well as determine the impact on IBD outcomes resulting from adaptations to treatments during COVID-19

Recruitment information / eligibility
Status Completed
Enrollment 3728
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 100 Years
Eligibility Inclusion Criteria: - Patients with IBD +/- flare +/- COVID 19 positivity Exclusion Criteria: - Patients below 16 - Patient with inactive IBD

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust Hull

Sponsors (1)
Lead Sponsor Collaborator
Hull University Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Flare of IBD needing change in therapy or surgery 3 months
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