Clinical Trials Logo
  1. Home
  2. Pulmonary Inflammation
  3. 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). — 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Completed NCT05815264 - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above Phase 1
Recruiting NCT04589936 - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Terminated NCT03944551 - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa N/A
Completed NCT06210737 - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years Phase 4
Terminated NCT04660084 - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT05702788 - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19) Phase 2
Not yet recruiting NCT04171674 - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation. N/A
Active, not recruiting NCT03140163 - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] N/A
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Recruiting NCT02515565 - Physiotherapy in Patients Hospitalized Due to Pneumonia. N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01416519 - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation N/A
Completed NCT01399723 - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia Phase 3
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01416506 - Community-Acquired Pneumonia (CAP) Surveillance N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A