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

NCT ID: NCT04410484

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3728 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-22

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases Coronavirus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

2

Patients with IBD self-isolating with suggestive COVID19 symptoms (Fever or persistent Cough) or tested positive for COVID19 during same period

No interventions assigned to this group

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

No interventions assigned to this group

Control Group

Consecutive patients with active IBD between 1st March 2019-30th June 2019

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients below 16
* Patient with inactive IBD
Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shaji Sebastian

Role: PRINCIPAL_INVESTIGATOR

Hull and East Yorkshire NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Hull, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

284920

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.