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

• ClinicalTrials.gov Identifier: NCT04257136
• Recruitment Status: Recruiting
• First Posted: February 5, 2020
• Last Update Posted: May 20, 2020
• Sponsor: Vivacelle Bio
• Information provided by (Responsible Party): Vivacelle Bio

Tracking Information

• First Submitted Date: February 3, 2020
• First Posted Date: February 5, 2020
• Last Update Posted Date: May 20, 2020
• Actual Study Start Date: February 17, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2020)

The primary endpoint of this study is the proportion of patients in whom mean blood pressure increased by at least 10 mmHg with a mean blood pressure target of 60 - 65 mmHg. [ Time Frame: 10 Months ]

The primary endpoint of this study is the proportion of patients in whom mean blood pressure increased by at least 10 mmHg with a mean blood pressure target of 60 - 65 mmHg.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 3, 2020)

The secondary endpoint of this study is the proportion 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 [ Time Frame: 10 Months ]

The secondary endpoint of this study is the proportion 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
• Official Title: VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
• 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.

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 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.

Analysis Populations: * Safety Analysis Set (SAF): all patients who have received any amount of VBI-S. * Intent to treat (ITT) population: all patients who have received any amount of VBI-S

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Septic Shock
• Sepsis
• Hypovolemia

Intervention

Drug: VBI-S

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

Study Arms

Experimental: Treatment

Treatment with VBI-S

Intervention: Drug: VBI-S

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 3, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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 or an elevated procalcitonin.
3. Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market.
4. Patient is on two or more pressor drugs at the following minimal doses: Levophed =20 mcg/minute, epinephrine 10 mcg/minute, dopamine 20 mcg/kg/minute, phenylephrine 180mcg/minute, vasopressin 4 units/hour, at full dose required to maintain a mean blood pressure of 65 mmHg or Patient is on Levophed or its equivalent at 55 mcg/min with conversion factors for other vasopressors to Levophed being 5.6 x Vasopressin ( in units/hour), 0.5 x dopamine( in mcg/kg/minute) epinephrine ( in mcg/minute) 0.1 x phenylephrine ( in mcg/minute) at full dose to maintain a mean blood pressure of 65 mmHg. (Predicted mortality >80%)
5. Sequential Organ Failure Assessment (SOFA) score >=15 (Predicted mortality >80%)
6. Systolic blood pressure < 90 mm Hg (or a drop of > 40 mm Hg from baseline)
7. Sepsis diagnosis

Exclusion Criteria:

1. Patients with a ventricular assist device
2. Acute coronary syndrome
3. Pregnant
4. Bronchospasm
5. Mesenteric ischemia
6. Emergency surgery
7. History of liver disease (Hepatitis B and C), chronic hepatic failure and /or cirrhosis
8. Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19
9. Clinically significant hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000)
10. Absolute neutrophil count of < 1000 mm3
11. Current participation or participation in another experimental or device study within the last 30 days before the start of this study
12. Patients with a known allergy to soybeans or eggs

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Cuthbert O Simpkins, MD, FACS; (318) 771-1294; cuthbert@vivacellebio.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04257136
• Other Study ID Numbers: VBI-S-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Vivacelle Bio
• Study Sponsor: Vivacelle Bio
• Collaborators: Not Provided

Investigators

• Principal Investigator: Cuthbert Simpkins, MD, FACS; Vivacelle Bio

• PRS Account: Vivacelle Bio
• Verification Date: May 2020