Recruiting
Phase 2

Evolocumab

Sponsor:

University of British Columbia

Code:

NCT03869073

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Evolocumab

Placebo

Study Details

Brief 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

Sepsis

Study ID

NCT03869073

Start date

Feb 11, 2019

Status verified date

Mar, 2020

Completion date

Feb 11, 2021

Anticipated

Primary completion date

Feb 11, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Signed informed consent
  • At least 19 years of age
  • Known or suspected infection
  • AND one or more of the following organ dysfunctions judged due to sepsis:

1. Cardiovascular- refractory hypotension (a systolic blood pressure (SBP) < 90 mm Hg or mean arterial pressure (MAP) < 60 mm Hg despite an IV fluid challenge of at least 30 ml/kg fluids), or use of vasopressor(s) to maintain SAP > 90 mm Hg or MAP > 60 mm Hg, or;
2. Respiratory: PaO2/FiO2 < 300 or PaO2/FiO2 < 200 if lung is the only organ dysfunction or SaO2:FiO2 150

Exclusion Criteria:

  • Known pregnancy
  • Underlying severe congestive heart failure (New York Heart Association (NYHA) IV), severe COPD (need for chronic oxygen or mechanical ventilation), severe liver disease (Child-Pugh Class C), cancer requiring chemotherapy, or transplantation (bone marrow, heart, lung, liver, pancreas, or small bowel) in the past 6 months or likely within the next 6 months
  • Previous episode of sepsis during that hospital admission
  • Absolute Neutrophil Count < 500/mm³
  • CD4 count < 50/mm³
  • Treating physician deems aggressive care unsuitable (i.e. no commitment to active care)
  • Participation in another interventional drug study within previous 1 month
  • Allergic to the study drug or any of its components
  • Lactation
  • Have signed a Do No Resuscitate (DNR) Form

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Evolocumab

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

Placebo

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

Central contacts

Genevieve L Rocheleau

604-682-2344grocheleau@providencehealth.bc.ca

Lynda Lazosky

llazosky@providencehealth.bc.ca

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Principal Investigator:

John Boyd, MD

More Information

Sponsor

University of British Columbia

Last update posted

Mar 3, 2020

Last verified

Mar, 2020

Keywords

  • Bacterial
  • Infection
  • Blood
  • Systemic
  • ICU

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-03-03.