Treatment of Severe Infection With Antihyperlipidemia Drug

Sponsor
Wolfson Medical Center
Study ID
NCT03634293
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab Injectable Product — DRUG
    Alirocumab is an human monoclonal antibodies directed against Proprotein convertase subtilisin/kexin type 9 (PCSK9). It is administered once every two weeks subcutaneously.
  • Saline Solution — DRUG
    The placebo will be 2 ml' of 0.9% saline injected subcutaneously.

Study Details

Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors increase LDL receptors by decreasing its degradation. In sepsis the pathogenic substances, endotoxin, lipoteichoic acid, phospholipomannan are the main cause of the ongoing inflammation that causes the severe damage and outcome. these substances are removed from the blood by the LDL receptors. By administering PCSK9 inhibitors to patients with sepsis/septic shock this inflammatory response can be stopped and by doing so improve the patients outcome.

Key Dates

Start date
Jan 31, 2019
Status verified
Aug 2018
Primary completion
Jan 31, 2021
Completion
Feb 28, 2021

Study Design

Enrollment
712 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: control group
    The group will receive 2 ml' saline subcutaneous injection upon randomization when admitted to the ICU with the diagnosis of sepsis or septic shock
  • Active Comparator: treatment group
    The group will receive a 2 ml' subcutaneous injection of the study drug Alirocumab 150 mg', upon randomization when admitted to the ICU with the diagnosis of sepsis or septic shock.

Primary Outcome Measure

survival [ Time Frame: At 28 days from randomization ]

Central Contacts

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