Inflammatory Bowel DiseasesPROTECT-ASUCNCT04411784
PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis
An observational study of Inflammatory Bowel Diseases and COVID, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Inflammatory Bowel Diseases, COVID
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2020to 31 Aug 2020
- 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
- Child, Adult, Older adult
Study population: In The UK alone approximately 6500 patients are admitted with ASUC each year
Who may be able to join
- Patients aged 16 -100 inclusive
- Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period
Who cannot join
- Patients aged 16 -100 inclusive
- Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period
- Admission for elective colectomy
- Pouch or stoma
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
Official title: PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis: A Multi-centre Observational Case- Control Study
Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes
Read the detailed description
The study aims to evaluate the process, evaluation and therapy variation in management of ASUC with reference to 2019 British Society of Gastroenterology guidelines and see whether there are any differences between ambulatory and hospital management in ASUC. Also to evaluate the outcomes in ASUC patients managed during the COVID-19 pandemic
- Conditions
- Inflammatory Bowel Diseases, COVID
- Medical subject headings
- Inflammatory Bowel Diseases
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 |
|---|---|---|
| Main group | Patient with Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period | |
| Control Group | Patients with ASUC managed in the unit from 1st Jan to 31st June 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure: The need for in-hospital colectomy or rescue therapy
The need for in-hospital colectomy or rescue therapy
Measured: 3 months
Secondary outcomes (7)
2.1: Duration and type/route of steroid use
Duration and type/route of steroid use
Measured: 3 months
2.2: 30 day colectomy free survival rates
30 day colectomy free survival rates
Measured: 3 months
2.3: Covid-19 infection rates
Covid-19 infection rates
Measured: 3 months
2.4: Rate of Rescue therapy use
Rate of Rescue therapy use
Measured: 3 months
2.5: Duration of hospital stay
Duration of hospital stay
Measured: 3 months
2.6: Admission severity scoring
Admission severity scoring
Measured: 3 months
2.7: Readmission rates
Readmission rates
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 posted2 Jun 2020
- Study start20 May 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 10 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 University Teaching Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411784
- Sponsor's protocol ID
- 284030
- Acronym
- PROTECT-ASUC
- Status last verified
- Nov 2022
- First submitted
- 29 May 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sebastian S, Patel KV, Segal JP, Subramanian S, Conley TE, Gonzalez HA, Kent AJ, Saifuddin A, Hicks L, Mehta S, Bhala N, Brookes MJ, Lamb CA, Kennedy NA; PROTECT ASUC collaborators; Walker GJ. Ambulatory care management of 69 patients with acute severe ulcerative colitis in comparison to 695 inpatients: insights from a multicentre UK cohort study. BMJ Open Gastroenterol. 2022 Jan;9(1):e000763. doi: 10.1136/bmjgast-2021-000763.
PubMed 35101886Sebastian S, Walker GJ, Kennedy NA, Conley TE, Patel KV, Subramanian S, Kent AJ, Segal JP, Brookes MJ, Bhala N, Gonzalez HA, Hicks LC, Mehta SJ, Lamb CA; PROTECT-ASUC Study Group. Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study. Lancet Gastroenterol Hepatol. 2021 Apr;6(4):271-281. doi: 10.1016/S2468-1253(21)00016-9. Epub 2021 Feb 2.
PubMed 33545083
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis: A Multi-centre Observational Case- Control Study
- ClinicalTrials.gov ID
- NCT04411784
- Acronym / sponsor ID
- PROTECT-ASUC / 284030
- Conditions
- Inflammatory Bowel Diseases, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 2 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.
Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes
Detailed description
The study aims to evaluate the process, evaluation and therapy variation in management of ASUC with reference to 2019 British Society of Gastroenterology guidelines and see whether there are any differences between ambulatory and hospital management in ASUC. Also to evaluate the outcomes in ASUC patients managed during the COVID-19 pandemic
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main group | – | –Patient with Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period |
| Control Group | – | –Patients with ASUC managed in the unit from 1st Jan to 31st June 2019 |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- In The UK alone approximately 6500 patients are admitted with ASUC each year
Key inclusion criteria (2 listed)
- Patients aged 16 -100 inclusive
- Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period
Key exclusion criteria (4 listed)
- Patients aged 16 -100 inclusive
- Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period
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
Primary outcome measure: The need for in-hospital colectomy or rescue therapy
Time frame: 3 months
The need for in-hospital colectomy or rescue therapy
7 secondary outcomes
2.1: Duration and type/route of steroid use
Time frame: 3 months
2.2: 30 day colectomy free survival rates
Time frame: 3 months
2.3: Covid-19 infection rates
Time frame: 3 months
2.4: Rate of Rescue therapy use
Time frame: 3 months
2.5: Duration of hospital stay
Time frame: 3 months
2.6: Admission severity scoring
Time frame: 3 months
2.7: Readmission rates
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 8 Nov 2022.
- Derived from this study: PubMed 35101886Sebastian S, Patel KV, Segal JP, Subramanian S, Conley TE, Gonzalez HA, Kent AJ, Saifuddin A, Hicks L, Mehta S, Bhala N, Brookes MJ, Lamb CA, Kennedy NA; PROTECT ASUC collaborators; Walker GJ. Ambulatory care management of 69 patients with acute severe ulcerative colitis in comparison to 695 inpatients: insights from a multicentre UK cohort study. BMJ Open Gastroenterol. 2022 Jan;9(1):e000763. doi: 10.1136/bmjgast-2021-000763.
- Derived from this study: PubMed 33545083Sebastian S, Walker GJ, Kennedy NA, Conley TE, Patel KV, Subramanian S, Kent AJ, Segal JP, Brookes MJ, Bhala N, Gonzalez HA, Hicks LC, Mehta SJ, Lamb CA; PROTECT-ASUC Study Group. Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study. Lancet Gastroenterol Hepatol. 2021 Apr;6(4):271-281. doi: 10.1016/S2468-1253(21)00016-9. Epub 2021 Feb 2.
- Individual participant dataSharing planned: Undecided
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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 University Teaching Hospitals
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 COVID, 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 2 inclusion and 4 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 8 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?
Primary outcome measure: The need for in-hospital colectomy or rescue therapy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411784, which also lists 2 linked publications.
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 8 Nov 2022.