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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).

NCT04433546 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-12-11

No results posted yet for this study

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.

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

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)

Sponsors & Collaborators

  • PhaseBio Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2020-12-02
Completion
2020-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433546 on ClinicalTrials.gov