VBI-S for Septic Shock

(VBI-S-02 Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Cuthbert O Simpkins, MD, FACS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Vivacelle Bio

Must be taking: Vasopressors

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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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.

Trial 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

Participant Groups

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.

Group I: VBI-S Experimental Treatment 1 Intervention

Treatment with VBI-S

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dignity Health Chandler Regional Medical Center Chandler, AZ

Memorial Health University Medical Center Savannah, GA

University Health Kansas City, MO

Oregon Health & Science University (OHSU) Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

Vivacelle Bio Lead Sponsor

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] Sepsis is the result of a dysregulated host immune response to an infection. An ideal therapy would target both the underlying infection and the dysregulated immune response. DIBI, a novel iron-binding polymer, was specifically developed as an antimicrobial agent and has also demonstrated in vivo anti-inflammatory properties.

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

Implementation of the Surviving Sepsis Campaign guidelines. [2019] Early identification and appropriate management of sepsis improves outcomes. Despite convincing data showing the benefits of early recognition and treatment of sepsis and septic shock, implementation of such evidence-based therapy is suboptimal. This review describes methods that have been shown to improve bedside application of the evidence-based guidelines.

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] The efficacy of intravenous immunoglobulin (IVIG) administration in patients with sepsis or septic shock remains unclear. A single-center retrospective study was conducted to evaluate the association between IVIG supplementation and favorable outcomes in patients with sepsis and low serum immunoglobulin G (IgG) levels.

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

Intravenous immunoglobulin for treating sepsis and septic shock. [2019] Death from severe sepsis and septic shock is common, and researchers have explored whether antibodies to the endotoxins in some bacteria reduces mortality. This review summarises the effects of intravenous immunoglobulin (IVIG) in patients with bacterial sepsis or septic shock on mortality, bacteriological failure rates, and duration of stay in hospital.

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

Septic shock: the changing Zeitgeist of management. [2021] Most interventions in critically unwell patients with septic shock are poorly supported by evidence, in part reflecting the difficulty of conducting trials in this heterogeneous group. Four important clinical trials in 2001-2 appeared to demonstrate mortality benefits associated with early goal-directed resuscitation, intensive glycaemic control, physiological-dose steroid replacement and activated protein C. However, recent evidence has not confirmed the beneficial effect of these interventions.