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Monoclonal Antibodies

Low Dose for Sepsis (PLEASe Trial)

Phase 2
Waitlist Available
Led By John Boyd, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days or less (may be discharged from critical care before day 28)
Awards & highlights

PLEASe Trial Summary

This study evaluates using evolocumab, a currently approved and marketed biologic drug, in a novel way. Patients who present to the emergency room or intensive care unit (ICU) with severe infection are eligible. Either the patient or their designated decision maker will be approached for consent. If they choose to participate they will be given either a single dose of evolocumab, a higher single dose of evolocumab,or a single dose of placebo. Participants will be followed during their stay in the ICU and will receive follow up phone calls at Day 28 and 90.

Eligible Conditions
  • Sepsis

PLEASe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days or less (may be discharged from critical care before day 7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days or less (may be discharged from critical care before day 7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma LTA and LPS curves
Secondary outcome measures
Changes in 28-day mortality
Changes in Vitals: fluid balance
Changes in Vitals: heart rate
+21 more

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288
5%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
HPR - Evolocumab
HPR - Placebo
NPR - Evolocumab
NPR - Placebo

PLEASe Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment1 Intervention
This treatment arm will receive the highest dose of evolocumab currently marketed and approved: 420mg. The dose will be given at a single time point within 4 hours of randomization. The dose will be administered through three subcutaneous injections, each in a different quadrant of the abdomen.
Group II: High DoseExperimental Treatment1 Intervention
This treatment arm will receive double the highest dose of evolocumab currently marketed and approved: 840mg. The dose will be given at a single time point within 4 hours of randomization. The dose will be administered through three subcutaneous injections, each in a different quadrant of the abdomen.
Group III: PlaceboPlacebo Group1 Intervention
This treatment arm will receive saline solution. The dose will be given at a single time point within 4 hours of randomization. The dose will be administered through three subcutaneous injections, each in a different quadrant of the abdomen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
FDA approved

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,980 Total Patients Enrolled
12 Trials studying Sepsis
40,501 Patients Enrolled for Sepsis
John Boyd, MDPrincipal InvestigatorUniversity of British Columbia, Providence Health Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study)
john boyd 2019. "Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03869073.
All > Sepsis
~6 spots leftby Apr 2025
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