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

NHS Trust

Status: Completed

Conditions: Inflammatory Bowel Diseases; Coronavirus Infection

Study type: Observational

Funder types: Other

Identifiers

NCT04410484

284920

Details and patient eligibility

About

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

Full 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

Enrollment: 3,728 patients

Sex: All

Ages: 16 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients below 16
• Patient with inactive IBD

Trial design

3,728 participants in 4 patient groups

1

Description:

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

Description:

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

3

Description:

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

Description:

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