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CompletedNCT04410484PREPARE IBDUpdated Nov 4, 2022

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

An observational study in Inflammatory Bowel Diseases and Coronavirus Infection, sponsored by Hull University Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by Hull University Teaching Hospitals NHS Trust · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
3,728
Ages
16 Years to 100 Years
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Inflammatory Bowel Diseases
  • Coronavirus Infection
03

In context

Inflammatory Bowel Diseases

1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.

This study's enrollment of 3,728 is above the median of 146 across 659 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Hull University Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients below 16
  • Patient with inactive IBD
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
3,728 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Flare of IBD needing change in therapy or surgery

    Time frame: 3 months

07

Study locations

1 site
  • Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
    Hull, United Kingdom
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References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04410484
Lead sponsor
Hull University Teaching Hospitals NHS Trust
Responsible party
Sponsor
First posted
Jun 1, 2020
Start date
May 22, 2020
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Nov 4, 2022

Study contacts

Shaji Sebastian
principal investigator · Hull and East Yorkshire NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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