NCT06072430 A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
| NCT ID | NCT06072430 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vivacelle Bio |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-08-06 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 46 participants in total. It began in 2024-08-06 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Cuthbert O Simpkins, MD, FACS
PRINCIPAL INVESTIGATOR
Vivacelle Bio
Frequently Asked Questions
Who can join the NCT06072430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06072430 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 46 participants.
Is NCT06072430 currently recruiting?
Yes, NCT06072430 is actively recruiting participants. Contact the research team at cuthbert@vivacellebio.com for enrollment information.
Where is the NCT06072430 trial being conducted?
This trial is being conducted at Chandler, United States, Savannah, United States, Kansas City, United States, Lincoln, United States and 2 additional locations.
Who is sponsoring the NCT06072430 clinical trial?
NCT06072430 is sponsored by Vivacelle Bio. The principal investigator is Cuthbert O Simpkins, MD, FACS at Vivacelle Bio. The trial plans to enroll 46 participants.