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

November 1, 2022 updated by: Hull University Teaching Hospitals NHS Trust
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

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

3728

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Hull, United Kingdom
        • Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

About 1 in 100- to 1 in 200 patients have IBD and up to 550,000 patients are estimated in the UK.

Description

Inclusion Criteria:

  • Patients with IBD +/- flare +/- COVID 19 positivity

Exclusion Criteria:

  • Patients below 16
  • Patient with inactive IBD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Admitted patients with IBD (with IBD OR due to COVID) whether tested or not tested for COVID between 1st March and 30th June 2020
2
Patients with IBD self-isolating with suggestive COVID19 symptoms (Fever or persistent Cough) or tested positive for COVID19 during same period
3
Patients with active IBD identified during the same study period. (definition: increased symptoms suggestive of flare, raised calprotectin, raised CRP, endoscopy or imaging during the previous 6 weeks showing active disease and contacted/reviewed during the study period , admission with IBD ( These will be identified through your helpline/ virtual clinics/Hot clinics/flare lines
Control Group
Consecutive patients with active IBD between 1st March 2019-30th June 2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flare of IBD needing change in therapy or surgery
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Shaji Sebastian, Hull and East Yorkshire NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2020

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 284920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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