Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation

A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Standard of Care; Biological: Ampion

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, 18 years to 89 years old (inclusive).
2. Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2.
3. Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).
4. A signed informed consent form from the patient or the patient's legal representative must be available.

Exclusion Criteria:

1. In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments.
2. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
3. Patient is on chronic immunosuppressive medication.
4. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
5. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
6. Patient has known pregnancy or is currently breastfeeding.
7. Participation in another clinical trial.
8. Baseline QT prolongation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ampion	Other: Standard of Care; Standard of Care; Biological: Ampion; Ampion, administered by intravenous infusion
Other: Standard of Care	Other: Standard of Care; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events	Incidence and severity of adverse events	Primary endpoint at day 5

Collaborators and Investigators

• Sponsor: Ampio Pharmaceuticals. Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): September 8, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AP-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No