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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Septic Shock; Hypovolemia
• Intervention / Treatment: Drug: VBI-S

Detailed Description

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 with absolute or relative hypovolemia.

STUDY TREATMENT Sepsis is a serious condition resulting from the presence of harmful microorganisms in the blood or other tissues and the body's response to their presence, leading to the malfunctioning of various organs. When hypotension due to sepsis cannot be reversed with the infusion of fluids the patient is in a state of septic shock. Septic shock is therefore an acute medical emergency and delayed therapy can lead to organ injury. VBI-S is intended to raise blood pressure in patients with septic shock.

Randomization and blinding: This is a randomized, controlled, open-label study and blinding is not applicable to this study.

Data Safety Monitoring Board: A Data Safety Monitoring Board (DSMB) will review the study data.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cuthbert O Simpkins, MD, FACS; Phone Number: 3187711294; Email: cuthbert@vivacellebio.com

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Dignity Health Chandler Regional Medical Center
      • Contact: Kristopher Roach, MD
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Recruiting
      • Memorial Health University Medical Center
      • Contact: Domenick Roma, MD
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • University Health
      • Contact: Michael Moncure, MD
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Withdrawn
      • Bryan Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Novant Healthcare
      • Contact: Daniel Feinstein, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University (OHSU)
      • Contact: Akram Khan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female at least 18 years of age.
2. 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.
3. Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market.
4. Sequential Organ Failure Assessment (SOFA) score ≥ 5

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
6. Documented dysregulated host response to an infection as indicated by an increase in SOFA score by ≥ 2 points after an infection per the SEPSIS 3 guideline.
7. Receiving vasopressors to maintain the target MAP of 65 mmHg.

Exclusion Criteria:

1. Patients with a ventricular assist device
2. Acute coronary syndrome
3. Pregnant
4. Acute bronchospasm
5. Acute Mesenteric ischemia
6. Emergency major surgery
7. Diagnosis of acute Hepatitis B or C.
8. Hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure.
9. White blood cell count of < 1000 mm3
10. 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.
11. Patients with a known allergy to soybeans or eggs
12. Patient is hypervolemic with assessment by physician or physician extender ultrasound 12 hours before infusion of VBI-S if hypervolemia is suspected.
13. Patient expected to expire within 12 hours.
14. Patients with disturbances in normal fat metabolism such as pathologic hyperlipemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VBI-S; Treatment with VBI-S	Drug: VBI-S; VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose of Pressor Drugs	The number of patients in whom the dose of pressor drugs could be decreased after infusion of VBI-S to maintain a mean arterial pressure of 60-65 mmHg.	12 months
Sequential Organ Failure Assessment (SOFA) Score	Change in Sequential Organ Failure Assessment (SOFA) Score on a scale of 0 to 24. A higher score indicates a worse outcome.	12 months
Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen	Change in ratio of partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (P/F ratio).	12 months
Arterial Oxygen Saturation	Change in arterial oxygen saturation.	12 months
Partial Pressure of Oxygen	Change in partial pressure of oxygen.	12 months
Serum Procalcitonin	Change in serum procalcitonin	12 months
Serum Creatinine	Change serum creatinine	12 months
Post-treatment Survival	Change in post-treatment survival	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Drug Reactions	The number and proportion (%) of patients with treatment-emergent adverse drug reactions.	12 months

Collaborators and Investigators

• Sponsor: Vivacelle Bio
• Investigators: Principal Investigator: Cuthbert O Simpkins, MD, FACS, Vivacelle Bio

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Shock, Septic; Hypovolemia
• Other Study ID Numbers: VBI-S-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No