A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)

NCT06072430 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VBI-S-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Septic Shock; Sepsis; Hypovolemia

Outcome Measures

Primary Outcomes (1)

• Elevation in Average Mean Arterial Pressure

  The primary endpoint is defined as an elevation in average mean arterial pressure by at least 10 mmHg from baseline within 3 hours of initiation of study treatment on Day 1

  12 months

Secondary Outcomes (8)

• Dose of Pressor Drugs

  12 months

• Sequential Organ Failure Assessment (SOFA) Score

  12 months

• Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen

  12 months

• Arterial Oxygen Saturation

  12 months

• Partial Pressure of Oxygen

  12 months

Other Outcomes (1)

• Adverse Drug Reactions

  12 months

Study Arms (1)

VBI-S

EXPERIMENTAL

Treatment with VBI-S

Drug: VBI-S

Interventions

VBI-S DRUG

VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.

VBI-S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years of age.
• Evidence of bacterial infection demonstrated by positive blood culture and/or a known source of infection and/or an elevated procalcitonin of ≥ 2 ng/ml.
• Patient has a mean blood pressure \< 65 mmHg that is unresponsive to fluids currently available on the market.
• Sequential Organ Failure Assessment (SOFA) score ≥ 5
• Sepsis diagnosis: The presence of infection which can be proven or suspected by 2 or more of the following criteria:
• Lactate \> 2 mmol/L
• Fever \> 38.3°C, or 101°F
• Hypothermia \< 36°C core temperature (\<96.8°F)
• Heart rate \> 90
• Tachypnea (respiratory rate ≥ 20/min)
• White blood cell count \>12,000 or less than 4,000, or with \>10% "bands" (immature forms)
• Elevated procalcitonin in serum (≥ 2ng/ml)
• Arterial hypoxemia (PaO2/FiO2 \< 300)
• Creatinine increase \> 0.5 mg/dL since hospital admission
• INR \> 1.5 or aPTT \> 60 seconds

You may not qualify if:

• Patients with a ventricular assist device
• Acute coronary syndrome
• Pregnant
• Acute bronchospasm
• Acute Mesenteric ischemia
• Emergency major surgery
• Diagnosis of acute Hepatitis B or C.
• Hematologic or coagulation disorders including thrombocytopenia (platelet count \<50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure.
• White blood cell count of \< 1000 mm3
• Current participation or participation in another experimental or device study within the last 30 days before the start of this study. Patient may be included if on other drugs are for COVID-19.
• Patients with a known allergy to soybeans or eggs
• Patient is hypervolemic with assessment by physician or physician extender ultrasound 12 hours before infusion of VBI-S if hypervolemia is suspected.
• Patient expected to expire within 12 hours.
• Patients with disturbances in normal fat metabolism such as pathologic hyperlipemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia.

Sponsors & Collaborators

• Vivacelle Bio: lead

Study Sites (6)

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

University Health

Kansas City, Missouri, 64108, United States

RECRUITING

Bryan Medical Center

Lincoln, Nebraska, 68506, United States

WITHDRAWN

Novant Healthcare

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Sepsis; Hypovolemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Cuthbert O Simpkins, MD, FACS

  Vivacelle Bio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cuthbert O Simpkins, MD, FACS

CONTACT

3187711294; cuthbert@vivacellebio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 10, 2023
• Study Start: August 6, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)