Alirocumab for Pyemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Grady Memorial Hospital, Atlanta, GA
Pyemia+1 More
Alirocumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Pyemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to Day 180

Day 30
Mortality
Hour 120
Bacterial endotoxin level
Interleukin-1 beta (IL-1 beta) Level
Interleukin-10 (IL-10) Level
Interleukin-6 (IL-6) Level
Lipoteichoic acid level
Tumor necrosis factor - alpha (TNF-alpha) Level
Up to Day 180
Days in Hospital
Days in ICU
ICU Mortality
Up to Day 30
Number of Vasopressor and Ventilation Free Days (VVFD)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
19%Viral upper respiratory tract infection
15%Back pain
15%Injection site reaction
10%Bronchitis
10%Urinary tract infection
10%Oedema peripheral
8%Influenza
8%Dizziness
8%Headache
8%Upper respiratory tract infection
6%Nausea
6%Arthralgia
6%Hyperkalaemia
6%Fatigue
6%Osteoarthritis
4%Diarrhoea
4%Fall
4%Musculoskeletal pain
4%Hypertension
4%Pneumonia
4%Syncope
2%Basal cell carcinoma
2%Musculoskeletal chest pain
2%Myalgia
2%Atrial fibrillation
2%Faecaloma
2%Small intestinal obstruction
2%Jaw fracture
2%Breast cancer
2%Cerebellar infarction
2%Chronic obstructive pulmonary disease
2%Sinusitis
2%Gout
2%Cough
2%Rash
2%Lumbar spinal stenosis
2%Hypoxic-ischaemic encephalopathy
2%Peripheral artery stenosis
2%Coronary artery disease
2%Mental disorder
2%Cardio-respiratory arrest
2%Cellulitis
2%Arthritis
2%Non-cardiac chest pain
2%Muscle spasms
2%Rhabdomyolysis
2%Pain in extremity
0%Acute coronary syndrome
0%Traumatic renal injury
0%Femur fracture
0%Mitral valve incompetence
0%Traumatic haemothorax
0%Vascular pseudoaneurysm
0%Cardiac failure congestive
0%Cardiomyopathy
0%Rheumatoid arthritis
0%Vertigo
0%Abdominal pain
0%Constipation
0%Retroperitoneal haematoma
0%Gastrointestinal haemorrhage
0%Spinal osteoarthritis
0%Cholelithiasis
0%Chest pain
0%Appendicitis
0%Device related infection
0%Craniocerebral injury
0%Humerus fracture
0%Multiple fractures
0%Bladder transitional cell carcinoma
0%Oesophageal squamous cell carcinoma
0%Skin cancer
0%Arachnoiditis
0%Essential tremor
0%Suicide attempt
0%Acute kidney injury
0%Nephrolithiasis
0%Pulmonary embolism
0%Haematoma
0%Peripheral artery occlusion
0%Peripheral ischaemia
0%Laceration
0%Neck pain
0%Depression
0%Dry skin
0%Road traffic accident
0%Benign fallopian tube neoplasm
0%Epistaxis
0%Spinal fracture
0%Acute myocardial infarction
0%Myocardial infarction
0%Biliary colic
0%Volvulus
0%Prostate cancer
0%Abdominal pain upper
0%Arthritis bacterial
0%Radius fracture
0%Rib fracture
0%Meningioma
0%Hypertensive crisis
0%Anaemia
0%Subdural haematoma
0%Presyncope
0%Retinal detachment
0%Aortic valve stenosis
0%Basedow's disease
0%Post procedural haematoma
0%Cerebrovascular accident
0%Hypotension
0%Hypovolaemic shock
0%Uterine leiomyoma
0%Hepatitis E
0%Transient ischaemic attack
0%Multiple sclerosis relapse
0%Pharyngitis
0%Intentional overdose
0%Adenocarcinoma of colon
0%Haemorrhagic anaemia
0%Angina pectoris
0%Angina unstable
0%Abdominal wall haematoma
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02023879) in the Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W) ARM group. Side effects include: Viral upper respiratory tract infection with 19%, Back pain with 15%, Injection site reaction with 15%, Bronchitis with 10%, Urinary tract infection with 10%.

Trial Design

2 Treatment Groups

Alirocumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Alirocumab · Has Placebo Group · Phase 1

Alirocumab
Drug
Experimental Group · 1 Intervention: Alirocumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alirocumab
2012
Completed Phase 3
~24010

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 180
Closest Location: Grady Memorial Hospital · Atlanta, GA
Photo of Atlanta 1Photo of Atlanta 2Photo of Atlanta 3
2011First Recorded Clinical Trial
0 TrialsResearching Pyemia
286 CompletedClinical Trials

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
534 Previous Clinical Trials
195,428 Total Patients Enrolled
Jonathan SevranskyLead Sponsor
Jonathan Sevransky, MD, MHSPrincipal InvestigatorEmory University
2 Previous Clinical Trials
6,501 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A positive blood culture or administration of an antimicrobial agent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.