VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients (VBI-S-02)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 an open label study, randomization and blinding are not applicable to this study. All patients entering this study will be treated with VBI-S. Data Safety Monitoring Board: A Data Safety Monitoring Board (DSMB) will review the study data.

Official Title
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VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients

Conditions
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Septic Shock, Sepsis, Hypovolemia

Intervention / Treatment
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* Drug: VBI-S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 and ≤ 11 with the maximum SOFA score of 24. Failure of standard therapy defined as no decrease in the SOFA score for 48 hours or a SOFA score > 11 on admission to the ICU. 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 INR > 1.5 or aPTT > 60 seconds Exclusion Criteria: 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 with the last 30 days before the start of this study. Patient may be included if on other drugs for COVID-19 Patients with a known allergy to soybeans or eggs Patient is hypervolemic as assessed by ultrasound Patient expected to expire within 12 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. | 10 months | 
| Adverse Drug Reactions | The number of patients with adverse drug reactions. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Pressure Increase | The number of patients in whom mean blood pressure increased by at least 10 mmHg. | 10 months | 
| 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. | 10 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. | 10 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). | 10 months | 
| Arterial Oxygen Saturation | Change in arterial oxygen saturation. | 10 months | 
| Partial Pressure of Oxygen | Change in partial pressure of oxygen. | 10 months | 
| Arterial Blood pH | Change in arterial blood pH. | 10 months | 
| Arterial Blood Base Excess | Change in arterial blood base excess. | 10 months | 
| Arterial Blood Carbon Dioxide | Change in arterial blood carbon dioxide. | 10 months |