VBI-S for Septic Shock

(VBI-S-02 Trial)

Recruiting at 4 trial locations

Overseen By Cuthbert O Simpkins, MD, FACS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vivacelle Bio

Must be taking: Vasopressors

Disqualifiers: Ventricular assist device, Acute coronary syndrome, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 hours on Day 1

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VBI-S to determine if it can safely and effectively raise blood pressure in people with septic shock. Septic shock occurs when an infection causes dangerously low blood pressure, and current treatments don't always succeed. Participants must have a bacterial infection and low blood pressure that doesn't improve with standard fluid treatments. This study may suit those already experiencing septic shock and needing additional options. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking medical advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently in another experimental study or have been in one within the last 30 days, unless the drugs are for COVID-19.

Is there any evidence suggesting that VBI-S is likely to be safe for humans?

Research has shown that VBI-S is generally safe for people. In earlier studies, participants reported no serious side effects, and no deaths were related to the treatment. This indicates that patients tolerate VBI-S well. The studies included individuals with septic shock, a serious condition characterized by a significant drop in blood pressure. Even in these critical cases, VBI-S proved to be safe. These findings support the safety of VBI-S for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

VBI-S is unique because it targets septic shock differently than standard treatments like antibiotics and vasopressors. While most current therapies focus on managing symptoms and supporting organ function, VBI-S is designed to directly modulate the immune response, potentially addressing the underlying causes of septic shock. Researchers are excited about VBI-S because it could offer quicker stabilization for patients, reducing the severity and duration of the condition, and ultimately improving survival rates.

What evidence suggests that VBI-S might be an effective treatment for septic shock?

Research has shown that VBI-S, the investigational treatment in this trial, may help increase blood pressure in patients with septic shock, a serious condition where blood pressure drops dangerously low. Studies found that VBI-S, which uses tiny particles called phospholipid nanoparticles, effectively raised the average blood pressure in these patients. This is crucial when standard treatments like fluid replacement fail. Early findings consistently suggest that VBI-S is both safe and effective for treating low blood pressure in septic shock. These results support the potential of VBI-S to help manage septic shock symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Cuthbert O Simpkins, MD, FACS

Principal Investigator

Vivacelle Bio

Are You a Good Fit for This Trial?

Adults at least 18 years old with septic shock and low blood pressure not improved by current fluids can join. They must have a moderate SOFA score (5-11), no improvement or high SOFA score upon ICU admission, signs of infection, fever or hypothermia, fast breathing, lactate levels above normal, and heart rate over 90.

Inclusion Criteria

My SOFA score is between 5 and 11, indicating some organ failure.

My condition did not improve after standard treatment in the ICU.

My average blood pressure is below 65 mmHg and doesn't improve with fluids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive VBI-S to elevate blood pressure in septic shock patients

3 hours on Day 1

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• VBI-S

Trial Overview The trial is testing VBI-S's ability to raise blood pressure in patients with septic shock due to low blood volume. It's an open-label study where everyone knows what treatment they're getting and it compares VBI-S against standard treatments.

How Is the Trial Designed?

Group I: VBI-S Experimental Treatment 1 Intervention

Treatment with VBI-S

Who Is Running the Clinical Trial?

Vivacelle Bio

Lead Sponsor

Trials

2

Recruited

70+

Published Research Related to This Trial

A systematic review of 27 studies involving 8,856 patients found that intravenous immunoglobulin (IVIG) significantly reduces mortality in patients with bacterial sepsis or septic shock, particularly with polyclonal IVIG, which showed a 36% reduction in mortality.

Monoclonal IVIG treatments, such as anti-endotoxins and anti-cytokines, did not demonstrate a significant reduction in mortality, indicating that polyclonal IVIG is the more effective option for treating sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous immunoglobulin for treating sepsis and septic shock. Alejandria, MM., Lansang, MA., Dans, LF., et al.[2019]

Recent evidence suggests that previously promising interventions for septic shock, such as early goal-directed resuscitation and intensive glycaemic control, may not provide the expected mortality benefits.

The challenges of conducting trials in critically ill patients contribute to the lack of strong evidence supporting many treatments for septic shock, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Septic shock: the changing Zeitgeist of management. Cheng, AC., Stephens, DP.[2021]

Early identification and management of sepsis significantly improves patient outcomes, yet the application of evidence-based therapies remains inconsistent in clinical practice.

The Surviving Sepsis Campaign has developed structured bundles to simplify the implementation of guidelines, leading to improved patient outcomes and reduced healthcare costs in hospitals that adopt these measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Surviving Sepsis Campaign guidelines. Mukherjee, V., Evans, L.[2019]

In a study of 239 patients with sepsis, those with low serum immunoglobulin G (IgG) levels who received intravenous immunoglobulin (IVIG) therapy had significantly lower 28-day and 90-day mortality rates compared to those who did not receive IVIG, suggesting a potential benefit of this treatment.

Patients receiving IVIG also experienced more days free from renal replacement therapy, indicating improved overall health outcomes, although serum IgG levels did not differ significantly between the IVIG and non-IVIG groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Intravenous Immunoglobulin Therapy for Patients With Sepsis and Low Immunoglobulin G Levels: A Single-Center Retrospective Study. Akatsuka, M., Masuda, Y., Tatsumi, H., et al.[2022]

DIBI, a novel iron-binding polymer, significantly reduced leukocyte adhesion and improved blood flow in mice with sepsis, indicating its potential to modulate the immune response effectively.

When used alongside the antibiotic imipenem, DIBI not only enhanced the antibiotic's effectiveness but also improved survival rates in infected mice, suggesting it could be a valuable addition to sepsis treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The novel iron chelator, DIBI, attenuates inflammation and improves outcome in colon ascendens stent peritonitis-induced experimental sepsis. Fokam, D., Aali, M., Dickson, K., et al.[2020]

Citations

1. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00009-9/fulltext

Efficacy and safety of phospholipid nanoparticles (VBI-S) in ... These preliminary findings suggest the safety and efficacy of VBI-S in treating hypotension in patients with septic shock. However, a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04257136

Study Details | NCT04257136 | VBI-S for the Treatment of ... This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38545092/

Efficacy and safety of phospholipid nanoparticles (VBI-S) in ... These preliminary findings suggest the safety and efficacy of VBI-S in treating hypotension in patients with septic shock.

4. journals.lww.com journals.lww.com/ccmjournal/fulltext/2024/01001/1470__phospholipid_nanoparticles_increase_p_f.1413.aspx

phospholipid nanoparticles increase p/f ratio in septic shock Hypotensive septic shock patients in whom fluids had failed to elevate MAP above 65 mmHg received VBI-S infusion. VBI-S was infused as a volume sufficient to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06072430

Study Details | NCT06072430 | A Phase III, Open Label, ... PURPOSE OF THE STUDY This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0891584924011262

A novel strategy to mitigate massive nitric oxide release ... Twenty patients with severe septic shock possessing a mean sequential organ failure assessment (SOFA) score of 14 were given VBI-S with a goal ...