Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Nebulized Ampion In Adults With Respiratory Distress Secondary to COVID-19 Infection

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Standard of Care; Biological: Ampion

• Study Type: Interventional
• Enrollment (Actual): 40
• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, ≥ 18 years old.
2. Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.

3. Respiratory distress as evidenced by at least two of the following:

   • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
   • Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90%
   • Requiring supplemental oxygen
   • Diagnosis of mild, moderate, or severe ARDS by Berlin definition
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 within the next 24 hours, irrespective of the provision of treatments.
2. Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
3. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
4. Patient is on chronic immunosuppressive medication.
5. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
6. 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).
7. Patient has known pregnancy or is currently breastfeeding.
8. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
9. 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, nebulized for inhalation
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	Day 5
Incidence and severity of adverse events	Incidence and severity of adverse events	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical status using 8-point ordinal scale	Efficacy measures for clinical improvement using 8-point ordinal scale: 0 = Uninfected, 1 = Ambulatory without limitation of activity, 2 = Ambulatory with limitation of activity, 3 = Hospitalized mild disease, no oxygen, 4 = Hospitalized mild disease, supplemental oxygen, 5 = Hospitalized severe disease, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized severe disease, intubation and mechanical ventilation, 7 = Hospitalized severe disease, ventilation plus additional organ support, 8 = Death	Day 5
Clinical status using 8-point ordinal scale	Efficacy measures for clinical improvement using 8-point ordinal scale: 0 = Uninfected, 1 = Ambulatory without limitation of activity, 2 = Ambulatory with limitation of activity, 3 = Hospitalized mild disease, no oxygen, 4 = Hospitalized mild disease, supplemental oxygen, 5 = Hospitalized severe disease, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized severe disease, intubation and mechanical ventilation, 7 = Hospitalized severe disease, ventilation plus additional organ support, 8 = Death	Day 28

Collaborators and Investigators

• Sponsor: Ampio Pharmaceuticals. Inc.

Publications and helpful links

General Publications

• Roshon M, Lemos-Filho L, Cherevka H, Goldberg L, Salottolo K, Bar-Or D. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of a Novel Inhaled Biologic Therapeutic in Adults with Respiratory Distress Secondary to COVID-19 Infection. Infect Dis Ther. 2022 Feb;11(1):595-605. doi: 10.1007/s40121-021-00562-z. Epub 2021 Nov 14.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

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-014

Drug and device information, study documents

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