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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04411784
Recruitment Status : Active, not recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
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 June 2, 2020
Actual Study Start Date May 20, 2020
Estimated Primary Completion Date July 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
Change History No Changes Posted
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, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 1, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 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
Removed Location Countries  
 
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
Responsible Party Hull University Teaching Hospitals NHS Trust
Study Sponsor Hull University Teaching Hospitals NHS Trust
Collaborators Not Provided
Investigators
Principal Investigator: Shaji Sebastian Hull University Teaching Hospitals
PRS Account Hull University Teaching Hospitals NHS Trust
Verification Date May 2020