NCT04839965

Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen

A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental oxygen.

Detailed description

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. This study aims to evaluate Ampion and clinical outcomes in patients with COVID-19 requiring supplemental oxygen.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Ampion	Ampion administered via intravenous infusion
OTHER	Saline	Placebo administered via intravenous infusion

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-02-07
• Completion: 2022-04-04
• First posted: 2021-04-09
• Last updated: 2022-11-30
• Results posted: 2022-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study