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

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ClinicalTrials.gov Identifier: NCT04410484
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

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

Condition or disease
Inflammatory Bowel Diseases Coronavirus Infection

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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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Flare of IBD needing change in therapy or surgery [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients below 16
  • Patient with inactive IBD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410484


Locations
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United Kingdom
Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
Hull, United Kingdom
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
Investigators
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Principal Investigator: Shaji Sebastian Hull and East Yorkshire NHS Trust
Additional Information:
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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04410484    
Other Study ID Numbers: 284920
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases