Last reviewed · How we verify

NCT05715567

Re-EValuating the Inhibition of Stress Erosions (REVISE) - COVID-19 Cohort Study

Status unknown Last updated 8 February 2023
What this trial tests

trial testing Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial (NCT03374800) in COVID-19 in 600 participants. Status unknown.

Timeline
1 December 2021
Primary endpoint
31 October 2023
31 December 2024

Quick facts

Lead sponsorMcMaster University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment600
Start date1 December 2021
Primary completion31 October 2023
Estimated completion31 December 2024
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

McMaster University

Who can join

18 and older, any sex, with COVID-19 or GastroIntestinal Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Commonly employed medications used in critically ill patients requiring life support include proton pump inhibitors (PPIs). These medications are thought to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite their widespread use, they do hold some risks which include infection in the form of pneumonia and diarrheal illnesses such as Clostridioides difficile infection (C. difficile). Emerging high-quality studies suggest PPI usage does not influence susceptibility to COVID-19 infection, however some studies suggest PPI use leads to poor outcomes in this population, including prolonged time on life-support and death. While we can appreciate the negative effects of PPI may be magnified in the sickest of patients, namely hospitalized patients with COVID-19, the beneficial or potentially harmful role they play in this population remains unclear. We aim to build a clinical profile to further describe critically ill patients with COVID-19 in Ontario using the infrastructure of an ongoing multicenter clinical trial of acid suppression. We will identify characteristics that predict poor outcomes among sick COVID patients, examining the impact of PPIs on this population.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis.
    Dennis B, Deane A, Lauzier F, Zytaruk N, et al · · 2024 · cited 3× · PMID 38704520 · DOI 10.1186/s12874-024-02233-2
  2. Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial.
    Dennis BB, Thabane L, Heels-Ansdell D, Dionne JC, et al · · 2023 · cited 2× · PMID 37644556 · DOI 10.1186/s13063-023-07589-2

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other McMaster University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05715567.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing