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Monoclonal Antibodies

Alirocumab for Sepsis (PALMS Trial)

Phase 1

Recruiting

Led By Jonathan Sevransky, MD, MHS

Research Sponsored by Jonathan Sevransky

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hour 120

Summary

This trial will test whether the drug alirocumab can reduce inflammation caused by an infection that has caused low blood pressure or difficulty breathing.

Who is the study for?

This trial is for adults with sepsis, showing signs like low blood pressure or breathing trouble due to infection. They must be receiving antimicrobials and have either cardiovascular dysfunction needing vasopressors or respiratory failure requiring support. Excluded are those with chronic conditions affecting survival, current participation in another sepsis drug study, known alirocumab allergy, pregnancy, or incarceration.

What is being tested?

The trial tests if alirocumab can reduce inflammation in sepsis patients. Participants will randomly receive one IV infusion of either alirocumab or a placebo to see if it helps manage their condition better than standard treatment alone.

What are the potential side effects?

While the specific side effects for this trial aren't listed, common ones for alirocumab may include symptoms like cold-like signs (runny nose, sneezing), injection site reactions (redness, itching), and possibly more serious allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 120

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 120

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 120 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bacterial endotoxin level

Lipoteichoic acid level

Secondary study objectives

Days in Hospital

Days in ICU

ICU Mortality

+6 more

Side effects data

From 2017 Phase 3 trial • 233 Patients • NCT02023879

19%

Viral upper respiratory tract infection

15%

Back pain

15%

Injection site reaction

10%

Oedema peripheral

10%

Bronchitis

10%

Urinary tract infection

Upper respiratory tract infection

Influenza

Headache

Dizziness

Osteoarthritis

Arthralgia

Hyperkalaemia

Nausea

Fatigue

Pneumonia

Hypertension

Diarrhoea

Syncope

Musculoskeletal pain

Fall

Rhabdomyolysis

Rash

Cough

Breast cancer

Peripheral artery stenosis

Faecaloma

Myalgia

Chronic obstructive pulmonary disease

Pain in extremity

Sinusitis

Cellulitis

Lumbar spinal stenosis

Gout

Atrial fibrillation

Non-cardiac chest pain

Cerebellar infarction

Basal cell carcinoma

Mental disorder

Jaw fracture

Arthritis

Musculoskeletal chest pain

Muscle spasms

Small intestinal obstruction

Hypoxic-ischaemic encephalopathy

Coronary artery disease

Cardio-respiratory arrest

100%

80%

60%

40%

20%

Study treatment Arm

Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)

Placebo Q2W

Alirocumab 75 mg Q2W/Up150 mg Q2W

Alirocumab 150 mg Q4W/Up150 mg Q2W

Alirocumab 150 mg Q4W (After Placebo Q2W)

Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AlirocumabExperimental Treatment1 Intervention

Critically ill participants with sepsis leading to cardiovascular and/or respiratory failure who are randomized to receive alirocumab.

Group II: PlaceboPlacebo Group1 Intervention

Critically ill participants with sepsis leading to cardiovascular and/or respiratory failure who are randomized to receive a placebo to match alirocumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alirocumab

2012

Completed Phase 3

~23510

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