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

Phase 2 Unknown 20 enrolled Vivacelle Bio

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2020-02-17
Primary completion: 2023-12-31
Completion: 2023-12-31

Outcome

Met primary endpoint

paper In all 20 (100%) patients, the goal of increasing MAP by at least 10 mmHg using VBI-S was achieved (p = 0.0087, effect size = 0.654). PMID 38545092 ↗

release “clinical trial of VBI-S in septic shock patients. Each of the thirteen(13) patients treated so far in the trial met the primary goal” vivacellebio.com ↗

Publications

Simpkins C, Moncure M, Klepacz H, Roach K, Benzaquen S, Diaz-Caballero L, Cohen J, Haase D, Kumar M, DeShield H, Manasia A, Rodriguez J, Anamthathmakula P, Hurt N, Mukherjee B, Talluri K. Efficacy and safety of phospholipid nanoparticles (VBI-S) in reversing intractable hypotension in patients with septic shock: a multicentre, open-label, repeated measures, phase 2a clinical pilot trial. EClinicalMedicine. 2024 Jan 29;68:102430. doi: 10.1016/j.eclinm.2024.102430. eCollection 2024 Feb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VBI-S	Other / unclassified	100 ml	Intravenous
Subject	VBI-S	Other / unclassified	200 ml	Intravenous
Subject	VBI-S	Other / unclassified	400 ml	Intravenous
Subject	VBI-S	Other / unclassified	800 ml	Intravenous