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

NCT03869073 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-03-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Evolocumab

Three pre-filled shrouded syringes for subcutaneous injection in abdomen.

DRUG

Placebo

Preservative free 0.9% sodium chloride. Three pre-filled shrouded syringes for subcutaneous injection in abdomen.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • John Boyd, MD · University of British Columbia, Providence Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2021-02-11
Completion
2021-02-11
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869073 on ClinicalTrials.gov