Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433546
Status:
TERMINATED
Last Update Posted:
2020-12-11
First Post:
2020-05-28
Brief Title:
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
Sponsor:
PhaseBio Pharmaceuticals Inc
Organization:
PhaseBio Pharmaceuticals Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company no longer pursing indication
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANGARD
Brief 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
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 ScreeningPre-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 357 days The subjects may be involved up to 42 days
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 357 days The subjects may be involved up to 42 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None