VBI-S / Vivacelle Bio - LARVOL DELTA

A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02) (clinicaltrials.gov) - P3 | N=46 | Recruiting | Sponsor: Vivacelle Bio | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock

A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02) (clinicaltrials.gov) - P3 | N=46 | Recruiting | Sponsor: Vivacelle Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Septic Shock

A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02) (clinicaltrials.gov) - P3 | N=46 | Not yet recruiting | Sponsor: Vivacelle Bio | Phase classification: P2/3 ➔ P3 | N=34 ➔ 46 | Trial completion date: Oct 2024 ➔ Jul 2025 | Initiation date: Oct 2023 ➔ Jul 2024 | Trial primary completion date: Aug 2024 ➔ Mar 2025

Enrollment change • Phase classification • Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Septic Shock

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. (PubMed, EClinicalMedicine) - P2 | "However, a definitive mortality benefit cannot be demonstrated without a randomized controlled study. The Naval Medical Research Command-Naval Advanced Medical Development program via the Medical Technology Enterprise Consortium."

Journal • P2a data • Dyslipidemia • Hypotension • Infectious Disease • Septic Shock

VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Vivacelle Bio | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Enrollment closed • Trial completion date • Trial primary completion date • Hypotension • Infectious Disease • Septic Shock • CRP

VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients (VBI-S-02) (clinicaltrials.gov) - P2/3 | N=34 | Not yet recruiting | Sponsor: Vivacelle Bio

New P2/3 trial • Hypotension • Infectious Disease • Septic Shock

VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Vivacelle Bio | Trial completion date: Mar 2022 ➔ Jul 2023 | Trial primary completion date: Dec 2021 ➔ Jun 2023

Trial completion date • Trial primary completion date • Hypotension • Infectious Disease • Septic Shock

Genomic and Virological Characterization of SARS-CoV-2 Variants in a Subset of Unvaccinated and Vaccinated U.S. Military Personnel. (PubMed, Front Med (Lausanne)) - "Notably, we found a 40-fold increase in viable virus in nasal swab samples from VBIs involving Delta as compared to unvaccinated personnel infected with other variants prior to the availability of approved vaccines. This study provides important insight about the genomic and virological characterization of SARS-CoV-2 isolates from a unique study population with a global presence."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Assessment of Federal Value-Based Incentive Programs and In-Hospital Clostridioides difficile Infection Rates. (PubMed, JAMA Netw Open) - "Health care facility-onset Clostridioides difficile infection (HO-CDI) rates reported to the US Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN) became a target quality metric for 2 Centers for Medicare & Medicaid Services (CMS) value-based incentive programs (VBIPs) in October 2016...In this study, VBIP implementation was associated with improvements in HO-CDI rates, independent of CDI testing method. Given that CMS payment policies have not previously been associated with improvements in other targeted health care-associated infection rates, future research should focus on elucidating the specific processes that contributed to improvement in HO-CDI rates to inform the design of future VBIP interventions."

Clinical • Journal • Infectious Disease

[VIRTUAL] A DISAPPEARING ACT: DEFINITIVE MANAGEMENT OF REFRACTORY VANISHING BRONCHUS INTERMEDIUS SYNDROME (CHEST 2021) - "Direct injections of steroids and Mitomycin were trialed to arrest proliferation of the granulation tissue. In the post-transplant setting, risk factors should be assessed to prognosticate for development of VBIS. VBIS may not respond to dilation and debulking, and a mixture of procedural interventions may abate restenosis. Definitive management may require bronchial sleeve resection."

Infectious Disease • Transplantation

VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Vivacelle Bio; Trial completion date: Dec 2020 ➔ Mar 2022; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Hypotension • Infectious Disease • Septic Shock

Dual-energy computed tomography of the neck-optimizing tube current settings and radiation dose using a 3D-printed patient phantom. (PubMed, Quant Imaging Med Surg) - "120 virtual blended images (VBIs) and 66 virtual monochromatic images (VMIs) were reconstructed and 12 regions of interest (bilaterally: common carotid arteries, subcutaneous soft tissue, mandibular bone, sternocleidomastoid muscle, submandibular gland, and mid-image: vertebral body of C2 and pharyngeal space) in six consecutive slices resulting in 96 measurements per scan were performed...Dual-energy protocols apply an estimated 120% of the single-energy radiation exposure and result in approximately 80% of the image quality. Tube current settings should be adapted to the desired information."

Clinical • Journal

How to make value-based health insurance designs more effective? A systematic review and meta-analysis. (PubMed, Eur J Health Econ) - "It is concluded that VBID implementation should be encouraged, especially for patients with heart diseases, and that full coverage was associated with higher effects. This review may provide insight for policy-makers into how to make VBIDs more effective."

Journal • Reimbursement • Retrospective data • Review