NCT04868890

A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Ampion	Inhaled Ampion
OTHER	Placebo	Inhaled Placebo

Timeline

• Start date: 2021-06-22
• Primary completion: 2022-02-16
• Completion: 2022-04-13
• First posted: 2021-05-03
• Last updated: 2022-12-07
• Results posted: 2022-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study