NCT04433546

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).

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Respiratory Distress Syndrome
• Coronavirus
• Hypoxic Respiratory Failure
• Hypoxemic Respiratory Failure
• Respiratory Complication
• Respiratory Insufficiency
• Cardiac Dysfunction
• Pneumonia
• Pulmonary Edema
• Pulmonary Inflammation
• Respiratory Failure
• Cytokine Storm
• COVID 19
• SARS-CoV-2
• Cardiac Event
• Cardiac Complication
• Cardiac Failure
• Cardiac Infarct

Interventions

Type	Name	Description
DRUG	Pemziviptadil (PB1046)	Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
DRUG	Low Dose (10 mg) Control	Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)

Timeline

• Start date: 2020-07-15
• Primary completion: 2020-12-02
• Completion: 2020-12-02
• First posted: 2020-06-16
• Last updated: 2020-12-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study