NCT03869073: PLEASe

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

Status unknown Phase 2 Last updated 3 March 2020

What this trial tests

Phase 2 trial testing Evolocumab in Sepsis in 36 participants. Status unknown.

Timeline

11 February 2019

Primary endpoint
11 February 2021

11 February 2021

Quick facts

Lead sponsor	University of British Columbia
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	36
Start date	11 February 2019
Primary completion	11 February 2021
Estimated completion	11 February 2021
Sites	3 locations across Canada

Drugs / interventions tested

• Evolocumab (EVOLOCUMAB) — full drug profile →
• Placebo

Conditions studied

• Sepsis — all drugs for Sepsis →

Sponsor

University of British Columbia

Who can join

19 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside.
   Bao X, Liang Y, Chang H, Cai T, et al · · 2024 · cited 101× · PMID 38185721 · DOI 10.1038/s41392-023-01690-3
2. Endothelial Activation and Microcirculatory Disorders in Sepsis.
   Raia L, Zafrani L. · · 2022 · cited 34× · PMID 35721048 · DOI 10.3389/fmed.2022.907992
3. The evolving landscape of PCSK9 inhibition in cancer.
   Oza PP, Kashfi K. · · 2023 · cited 32× · PMID 37059376 · DOI 10.1016/j.ejphar.2023.175721
4. Proprotein Convertase Subtilisin/Kexin Type 9 Loss-of-Function Is Detrimental to the Juvenile Host With Septic Shock.
   Atreya MR, Whitacre BE, Cvijanovich NZ, Bigham MT, et al · · 2020 · cited 18× · PMID 32769621 · DOI 10.1097/ccm.0000000000004487
5. Genetic variants associated with sepsis.
   Engoren M, Jewell ES, Douville N, Moser S, et al · · 2022 · cited 17× · PMID 35275946 · DOI 10.1371/journal.pone.0265052
6. Multiomic molecular patterns of lipid dysregulation in a subphenotype of sepsis with higher shock incidence and mortality.
   Augustin B, Wu D, Black LP, Bertrand A, et al · · 2024 · cited 3× · PMID 39716214 · DOI 10.1186/s13054-024-05216-3
7. Detrimental effects of PCSK9 loss-of-function in the pediatric host response to sepsis are mediated through independent influence on Angiopoietin-1.
   Atreya MR, Cvijanovich NZ, Fitzgerald JC, Weiss SL, et al · · 2023 · cited 2× · PMID 37365661 · DOI 10.1186/s13054-023-04535-1
8. Low PCSK-9 levels Are Associated with Favorable Neurologic Function after Resuscitation from out of Hospital Cardiac Arrest.
   Merrelaar A, Buchtele N, Schriefl C, Clodi C, et al · · 2020 · cited 2× · PMID 32796672 · DOI 10.3390/jcm9082606