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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
Acute respiratory or cardiovascular organ dysfunction attributed to sepsis as evidenced by specific requirements
Anticipated or confirmed intensive care unit (ICU) admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 120
Awards & highlights

PALMS Trial 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.Check my eligibility
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.See study design
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.

PALMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe lung or heart problems due to a serious infection.
Select...
I am expected to be or have been admitted to the ICU.
Select...
I am being treated for an infection with antibiotics and have had blood tests to confirm it.

PALMS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bacterial endotoxin level
Lipoteichoic acid level
Secondary outcome measures
Days in Hospital
Days in ICU
ICU Mortality
+6 more

Side effects data

From 2017 Phase 3 trial • 233 Patients • NCT02023879
15%
Viral upper respiratory tract infection
13%
Fall
10%
Diarrhoea
9%
Back pain
8%
Hypertension
8%
Upper respiratory tract infection
8%
Influenza
8%
Cough
7%
Urinary tract infection
7%
Fatigue
7%
Osteoarthritis
7%
Arthralgia
7%
Injection site reaction
7%
Depression
6%
Musculoskeletal pain
6%
Myalgia
6%
Headache
5%
Non-cardiac chest pain
5%
Oedema peripheral
5%
Dizziness
5%
Gout
4%
Muscle spasms
4%
Bronchitis
3%
Nausea
3%
Rash
3%
Laceration
3%
Acute myocardial infarction
3%
Syncope
3%
Pain in extremity
3%
Sinusitis
2%
Cardiac failure congestive
2%
Basal cell carcinoma
2%
Presyncope
2%
Hypotension
2%
Coronary artery disease
2%
Prostate cancer
1%
Retinal detachment
1%
Small intestinal obstruction
1%
Hypovolaemic shock
1%
Pharyngitis
1%
Femur fracture
1%
Arachnoiditis
1%
Retroperitoneal haematoma
1%
Device related infection
1%
Myocardial infarction
1%
Gastrointestinal haemorrhage
1%
Vertigo
1%
Basedow's disease
1%
Intentional overdose
1%
Post procedural haematoma
1%
Bladder transitional cell carcinoma
1%
Suicide attempt
1%
Haemorrhagic anaemia
1%
Abdominal pain
1%
Cerebrovascular accident
1%
Hyperkalaemia
1%
Aortic valve stenosis
1%
Abdominal wall haematoma
1%
Chest pain
1%
Cholelithiasis
1%
Pneumonia
1%
Subdural haematoma
1%
Vascular pseudoaneurysm
1%
Spinal osteoarthritis
1%
Skin cancer
1%
Multiple sclerosis relapse
1%
Transient ischaemic attack
1%
Haematoma
1%
Peripheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
Alirocumab 150 mg Q4W/Up150 mg Q2W
Alirocumab 75 mg Q2W/Up150 mg Q2W
Placebo Q2W
Alirocumab 150 mg Q4W (After Placebo Q2W)

PALMS 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

Find a Location

Who is running the clinical trial?

Jonathan SevranskyLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,695 Total Patients Enrolled
Jonathan Sevransky, MD, MHSPrincipal InvestigatorEmory University
2 Previous Clinical Trials
6,501 Total Patients Enrolled
1 Trials studying Sepsis
501 Patients Enrolled for Sepsis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the prime objective of this trial?

"This medical trial will assess Bacterial endotoxin level over a period of 120 hours as its primary outcome. Secondary measurements include Interleukin-1 beta (IL-1), Interleukin-10 (IL-10) and Tumor necrosis factor - alpha (TNF-alpha). Elevated levels of these proinflammatory cytokines are associated with worse outcomes in patients suffering from sepsis."

Answered by AI

How hazardous is Alirocumab for those in the trial?

"Taking into account the limited information available, Alirocumab was given a score of 1 for safety due to it being in its first stage of clinical research."

Answered by AI

Can I register for participation in this clinical experiment?

"This medical study is enrolling 50 pyemia patients aged between 18 and 90. To meet the criteria, participants must be using vasopressor agents to maintain a mean arterial pressure of 65 mm Hg, have acute hypoxemic respiratory failure necessitating intubation or positive pressure ventilation, require ICU admission, and evidence suspected infection as evidenced by blood cultures and antimicrobial agent administration."

Answered by AI

Is there currently a recruitment phase for this clinical experiment?

"According to the clinicaltrials.gov database, this medical trial is not currently enrolling patients. The experiment was initially made available on September 1st 2022 and has been amended as recently as July 19th 2022. Nevertheless, there are 169 other trials that are still actively recruiting participants at present."

Answered by AI

Is this research study open to individuals over 45 years of age?

"The qualifications for this clinical study state that potential participants must be 18-90 years old. Separately, there are 34 trials available to minors and 144 studies approved for seniors."

Answered by AI
~0 spots leftby Apr 2024