Inflammatory Bowel DiseasesPREPARE IBDNCT04410484
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 of Inflammatory Bowel Diseases and Coronavirus Infection, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Coronavirus Infection
- How many people
- 3,728 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2020to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: About 1 in 100- to 1 in 200 patients have IBD and up to 550,000 patients are estimated in the UK.
Who may be able to join
- Patients with IBD +/- flare +/- COVID 19 positivity
Who cannot join
- Patients below 16
- Patient with inactive IBD
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
Hull
About this study
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
- Conditions
- Inflammatory Bowel Diseases, Coronavirus Infection
- Medical subject headings
- Inflammatory Bowel Diseases, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flare of IBD needing change in therapy or surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start22 May 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shaji Sebastian, Principal investigator, Hull and East Yorkshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410484
- Sponsor's protocol ID
- 284920
- Acronym
- PREPARE IBD
- Status last verified
- Nov 2022
- First submitted
- 29 May 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04410484
- Acronym / sponsor ID
- PREPARE IBD / 284920
- Conditions
- Inflammatory Bowel Diseases, Coronavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,728 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 22 May 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- About 1 in 100- to 1 in 200 patients have IBD and up to 550,000 patients are estimated in the UK.
Key inclusion criteria (1 listed)
- Patients with IBD +/- flare +/- COVID 19 positivity
Key exclusion criteria (2 listed)
- Patients below 16
- Patient with inactive IBD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flare of IBD needing change in therapy or surgery
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Resulting publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaji Sebastian principal investigator
Hull and East Yorkshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Coronavirus Infection, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flare of IBD needing change in therapy or surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.