Alirocumab in Patients With Sepsis

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the drug alirocumab, which may lower cholesterol, can reduce the amount of inflammation caused by an infection that has caused either low blood pressure or difficulty breathing. Participants will be randomized to receive a single IV infusion of alirocumab or a placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonathan Sevransky
• Collaborator: Regeneron Pharmaceuticals

Criteria

Inclusion Criteria:

• Suspected or confirmed infection as evidenced by ordering of blood cultures and administration of at least one antimicrobial agent

• Acute respiratory or cardiovascular organ dysfunction attributed to sepsis as evidenced by at least one of the following requirements:

• Vasopressor Requirement - Continuous infusion of norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine or other vasopressor agents at any dose for greater than 1 hour and required to maintain a mean arterial pressure ≥ 65 mm Hg despite intravenous crystalloid infusion of at least 1000cc

• Respiratory Support Requirement - Acute hypoxemic respiratory failure defined as persistent hypoxemia requiring (1) intubation and mechanical ventilation, or (2) positive pressure ventilation via tight-fitting face mask or (3) high flow nasal cannula ≥ 45 liters per minute (LPM) flow and fraction of inspired oxygen (FiO2) ≥ 0.40

• Anticipated or confirmed intensive care unit (ICU) admission

Exclusion Criteria:

• Organ dysfunction present > 24 hours at time randomization

• Limitations of care (defined as refusal of cardiovascular and respiratory support described under inclusion criteria) including "do not intubate" (DNI) status

• Development of sepsis while in the hospital ( i.e not present on admission to hospital)

• Chronic hypoxemia requiring supplemental non-invasive oxygen or home mechanical ventilation

• Chronic cardiovascular failure requiring home mechanical hemodynamic support or home chemical hemodynamic support

• Known allergy or known contraindication to alirocumab

• Chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of < 30 days unrelated to current sepsis diagnosis (e.g, stage IV malignancy, neurodegenerative disease, etc.)

• Requirement of more than 6 liters (L) nasal cannula (NC) if not receiving invasive mechanical ventilation

• Pregnancy

• Prisoner or incarceration

• Current participation in another interventional pharmaceutical research study for sepsis

• Inability or unwillingness of subject or legal surrogate/representative to give written informed consent