Alirocumab in Patients with Sepsis

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Jonathan Sevransky
Study ID
NCT05469347
Phase
PHASE1
Status
Completed

Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    A 600 mg dose of alirocumab (which is equivalent to 8mg/kg for a 75kg patient) will be administered once via IV over an approximately 30 ± 10 minute infusion using an infusion pump.
  • Placebo — DRUG
    A placebo to match a 600 mg dose of alirocumab will be administered once via IV over an approximately 30 ± 10 minute infusion using an infusion pump.

Study Details

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.

Key Dates

Start date
Jan 4, 2023
Status verified
Mar 2025
Primary completion
Feb 18, 2025
Completion
Feb 23, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab
    Critically ill participants with sepsis leading to cardiovascular and/or respiratory failure who are randomized to receive alirocumab.
  • Placebo Comparator: Placebo
    Critically ill participants with sepsis leading to cardiovascular and/or respiratory failure who are randomized to receive a placebo to match alirocumab.

Primary Outcome Measure

Bacterial endotoxin level [ Time Frame: Hour 120 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-
Grady Memorial HospitalAtlantaGeorgia30303-

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GAGrady Memorial Hospital· Atlanta, GA

Related Studies