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Virus Therapy

VBI-S for Low Blood Pressure in Septic Shock

Phase 2
Waitlist Available
Led By Cuthbert Simpkins, MD, FACS
Research Sponsored by Vivacelle Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights

Study Summary

This trial is testing a drug to see if it can raise blood pressure in patients with septic shock who have low blood volume.

Who is the study for?
Adults with septic shock and low blood pressure despite fluid treatment, a SOFA score of 5 or more, signs of infection like fever or elevated white cell count, and organ dysfunction. Excluded are those with heart devices, recent heart attacks, pregnancy, severe lung or liver conditions, bleeding disorders, soybean or egg allergies.Check my eligibility
What is being tested?
The trial is testing VBI-S's ability to raise blood pressure in patients with septic shock who have not responded to standard fluids. It aims to determine the safety and effectiveness of this intervention for these critically ill patients.See study design
What are the potential side effects?
While specific side effects of VBI-S are not listed here, common risks may include allergic reactions due to its components (soybeans/eggs), potential worsening of infection symptoms or new infections due to immune system effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with VBI-S

Find a Location

Who is running the clinical trial?

Vivacelle BioLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Septic Shock
34 Patients Enrolled for Septic Shock
Cuthbert Simpkins, MD, FACSPrincipal InvestigatorVivacelle Bio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this method been federally regulated?

"This treatment received a safety rating of 2. This is due to the fact that it is only in Phase 2 trials, meaning while there is evidence supporting its safety, there are no studies yet which suggest it is an effective intervention."

Answered by AI

Are there a lot of hospitals participating in this research project within the state?

"Currently, this study is enrolling patients at Einstine Medical Center in East Norriton, Pennsylvania, Dignity Health in Chandler, Arizona, and Henry Ford Health System in Detroit, Michigan. There are 10 other locations where recruitment is happening."

Answered by AI

Is this research still looking for volunteers?

"The listed clinical trial on clinicaltrials.gov is still recruiting patients, with the study having been posted on February 17th, 2020 and edited as recently as October 26th, 2020."

Answered by AI

What is the total number of participants in this test?

"In order for this clinical trial to move forward, 20 patients that meet the pre-determined criteria must be recruited. The sponsor, Vivacelle Bio, has chosen various locations across America to conduct the trial; two examples are Einstine Medical Center in East Norriton, Pennsylvania and Dignity Health in Chandler, Arizona."

Answered by AI
~4 spots leftby Mar 2025