PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis (PROTECT-ASUC)

• ClinicalTrials.gov Identifier: NCT04411784
• Recruitment Status: Completed
• First Posted: June 2, 2020
• Last Update Posted: November 8, 2022
• Sponsor: Hull University Teaching Hospitals NHS Trust
• Information provided by (Responsible Party): Hull University Teaching Hospitals NHS Trust

Tracking Information

• First Submitted Date: May 29, 2020
• First Posted Date: June 2, 2020
• Last Update Posted Date: November 8, 2022
• Actual Study Start Date: May 20, 2020
• Actual Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 1, 2020)

• 2.1: Duration and type/route of steroid use [ Time Frame: 3 months ]
  Duration and type/route of steroid use
• 2.2: 30 day colectomy free survival rates [ Time Frame: 3 months ]
  30 day colectomy free survival rates
• 2.3: Covid-19 infection rates [ Time Frame: 3 months ]
  Covid-19 infection rates
• 2.4: Rate of Rescue therapy use [ Time Frame: 3 months ]
  Rate of Rescue therapy use
• 2.5: Duration of hospital stay [ Time Frame: 3 months ]
  Duration of hospital stay
• 2.6: Admission severity scoring [ Time Frame: 3 months ]
  Admission severity scoring
• 2.7: Readmission rates [ Time Frame: 3 months ]
  Readmission rates

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis
• 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
• Brief 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
• 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 Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: In The UK alone approximately 6500 patients are admitted with ASUC each year

Condition

• Inflammatory Bowel Diseases
• COVID

• Intervention: Not Provided

Study Groups/Cohorts

• 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

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.
• Sebastian 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. Erratum In: Lancet Gastroenterol Hepatol. 2021 Apr;6(4):e3.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 3, 2022): 10
• Original Estimated Enrollment (submitted: June 1, 2020): 200
• Actual Study Completion Date: August 31, 2020
• Actual Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients aged 16 -100 inclusive
• Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 100 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04411784
• Other Study ID Numbers: 284030
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Hull University Teaching Hospitals NHS Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Hull University Teaching Hospitals NHS Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shaji Sebastian; Hull University Teaching Hospitals

• PRS Account: Hull University Teaching Hospitals NHS Trust
• Verification Date: November 2022