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Patients with COVID-19 for Coronavirus

N/A
Recruiting
Led By Brittany Dennis, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥18 years old projected to receive invasive mechanical ventilation for ≥48 hours according to the treating physician
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days (during the index hospital admission, censored at 90 days)
Awards & highlights

Summary

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.

Eligible Conditions
  • Coronavirus
  • Gastrointestinal Bleeding

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days (while in icu,censored at 90 days after randomization)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days (while in icu,censored at 90 days after randomization) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Safety Outcome: 90 Day Mortality
Rate of clinically important gastro-intestinal bleeding
Secondary outcome measures
C. difficile infection
Hospital mortality
Patient important GI bleeding
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients without COVID-19Experimental Treatment1 Intervention
Group II: Patients with COVID-19Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,612,641 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,518,642 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
27,827 Total Patients Enrolled
~160 spots leftby Sep 2025