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

Trial Summary

What is the purpose of this trial?

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 relative hypovolemia.

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.

What data supports the effectiveness of the treatment VBI-S for septic shock?

The research on intravenous immunoglobulin (IVIG) therapy, which is sometimes used in sepsis treatment, suggests that it may help improve outcomes in patients with sepsis and low immunoglobulin G levels. This could imply potential benefits of similar treatments like VBI-S in managing septic shock. ^{1 2 3 4 5}

Research Team

Cuthbert O Simpkins, MD, FACS

Principal Investigator

Vivacelle Bio

Eligibility Criteria

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.

I am 18 years old or older.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The novel iron chelator, DIBI, attenuates inflammation and improves outcome in colon ascendens stent peritonitis-induced experimental sepsis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation of the Surviving Sepsis Campaign guidelines. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Intravenous Immunoglobulin Therapy for Patients With Sepsis and Low Immunoglobulin G Levels: A Single-Center Retrospective Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intravenous immunoglobulin for treating sepsis and septic shock. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Septic shock: the changing Zeitgeist of management. [2021]