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Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS). — VANGARD  

Pneumonia Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (PB1046), a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)

Clinical Trial Summary

This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.

Clinical Trial Description

The study will consist of a Screening/Pre-treatment period, on-site randomization to study treatment. On Day 0 (Visit 2) subjects who meet inclusion criteria and none of exclusion criteria will receive a weekly subcutaneous injection that will continue once weekly until hospital discharge or for a maximum of 4 weeks during hospitalization, whichever is shorter. All subjects will be randomized to either a low control (10 mg), middle (40 mg), or high (100 mg) dose of active treatment. If subject is not discharged, they will continue to Day 7, 14, 21 treatments. Pemziviptadil (PB1046) is expected to improve the clinical outcomes of hospitalized COVID-19 subjects with an earlier hospital discharge and improvement in survival. The duration of hospitalization for each subject will be determined by clinical status independent of study procedures. The estimated duration of the study for each subject, including screening, is approximately 35+7 days. The subjects may be involved up to 42 days. ;

Study Design

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Cardiac Complication
  • Cardiac Dysfunction
  • Cardiac Event
  • Cardiac Failure
  • Cardiac Infarct
  • Clinical Deterioration
  • Coronavirus
  • COVID 19
  • Cytokine Storm
  • Heart Failure
  • Hypoxemic Respiratory Failure
  • Hypoxic Respiratory Failure
  • Inflammation
  • Pneumonia
  • Pulmonary Edema
  • Pulmonary Inflammation
  • Pulmonary Valve Insufficiency
  • Respiratory Complication
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Respiratory Failure
  • Respiratory Insufficiency
  • SARS-CoV-2
  • Syndrome
Clinical Trial Details
NCT number NCT04433546
Study type Interventional
Source PhaseBio Pharmaceuticals Inc.
Contact
Status Terminated
Phase Phase 2
Start date July 15, 2020
Completion date December 2, 2020
View Details
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