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Septic ShockPhase 3VBI-S-02NCT06072430

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

A Phase 3 study testing VBI-S in people with Septic Shock and Sepsis, run by Vivacelle Bio at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock, Sepsis, Hypovolemia
What is being tested?
VBI-S
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
5 sitesUnited States
Study dates
6 Aug 2024to 29 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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.
  • Receiving vasopressors to maintain the target MAP of 65 mmHg.

Who cannot join

  • Patients with a ventricular assist device
  • Acute coronary syndrome
  • Pregnant
  • Acute bronchospasm
  • Acute Mesenteric ischemia
  • Emergency major surgery
Show all 14Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Dignity Health Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • University Health

    Kansas City, Missouri, 64108

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Novant Healthcare

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
VBI-S
Medical subject headings
Shock, Septic, Sepsis, Hypovolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VBI-SDrug

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

Study groups in NCT06072430
Study groupRoleWhat they receive
VBI-SExperimentalTreatment with VBI-S
Receives: Drug: VBI-S

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (8)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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).

    Measured: 12 months

  4. Arterial Oxygen Saturation

    Change in arterial oxygen saturation.

    Measured: 12 months

  5. Partial Pressure of Oxygen

    Change in partial pressure of oxygen.

    Measured: 12 months

  6. Serum Procalcitonin

    Change in serum procalcitonin

    Measured: 12 months

  7. Serum Creatinine

    Change serum creatinine

    Measured: 12 months

  8. Post-treatment Survival

    Change in post-treatment survival

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start6 Aug 2024
  3. Primary completion29 Jun 2026
  4. Study completion29 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072430
Sponsor's protocol ID
VBI-S-02
Acronym
VBI-S-02
Status last verified
Apr 2025
First submitted
14 Sep 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VBI-S in people with Septic Shock and Sepsis, run by Vivacelle Bio at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elevation in Average Mean Arterial Pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06072430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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