Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868890
Status:
TERMINATED
Last Update Posted:
2022-12-07
First Post:
2021-04-22
Brief Title:
A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19
Sponsor:
Ampio Pharmaceuticals Inc
Organization:
Ampio Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The AP-019 study was prematurely terminated by the sponsor after determining that insufficient events were occurring to analyze the primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with respiratory distress due to COVID-19
Detailed Description:
The severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 has resulted in the pandemic spread of coronavirus disease 2019 COVID-19 which has a high rate of infection has a high rate of hospitalization has overwhelmed healthcare systems and can be fatal
Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels Ampion has the potential to improve clinical outcomes for COVID-19 patients by reducing inflammatory cytokines correlated with the disease and respiratory complications such as Acute Lung Injury ALI and Acute Respiratory Distress Syndrome ARDS
This study aims to evaluate the effects of Ampion on mortality and clinical outcomes in patients with respiratory distress due to COVID-19
Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels Ampion has the potential to improve clinical outcomes for COVID-19 patients by reducing inflammatory cytokines correlated with the disease and respiratory complications such as Acute Lung Injury ALI and Acute Respiratory Distress Syndrome ARDS
This study aims to evaluate the effects of Ampion on mortality and clinical outcomes in patients with respiratory distress due to COVID-19
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