Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study)

Sponsor
University of British Columbia
Study ID
NCT03869073
Phase
PHASE2
Status
Unknown

Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Three pre-filled shrouded syringes for subcutaneous injection in abdomen.
  • Placebo — DRUG
    Preservative free 0.9% sodium chloride. Three pre-filled shrouded syringes for subcutaneous injection in abdomen.

Study Details

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.

Key Dates

Start date
Feb 11, 2019
Status verified
Mar 2020
Primary completion
Feb 11, 2021
Completion
Feb 11, 2021

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose
    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.
  • Experimental: High Dose
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Area under the plasma LTA and LPS curves [ Time Frame: 7 days or less (as data is collected from participants only while they are admitted to critical care, they may be discharged or moved to a different ward before day 7 and therefore subsequent time points would be not be collected) ]

Central Contacts

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