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

NCT04410484 | Completed

• 1 other identifier: 284920
• Study Type: observational
• Target: 3,728
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Inflammatory Bowel Diseases; Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• Flare of IBD needing change in therapy or surgery

  3 months

Study Arms (4)

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

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients below 16
• Patient with inactive IBD

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust

Hull, United Kingdom

Location

Related Links

• Resulting publication

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Coronavirus Infections

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Shaji Sebastian

  Hull and East Yorkshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 1, 2020
• Study Start: May 22, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

GB (1)