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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ampion
Standard of Care
Sponsored by
Ampio Pharmaceuticals. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ampion

Standard of Care

Arm Description

Ampion

Standard of Care

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events
Incidence and severity of adverse events
Incidence and severity of adverse events
Incidence and severity of adverse events

Secondary Outcome Measures

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
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

Full Information

First Posted
October 27, 2020
Last Updated
March 18, 2022
Sponsor
Ampio Pharmaceuticals. Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04606784
Brief Title
Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress
Official Title
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Nebulized Ampion In Adults With Respiratory Distress Secondary to COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ampio Pharmaceuticals. Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ampion
Arm Type
Experimental
Arm Description
Ampion
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Standard of Care
Intervention Type
Biological
Intervention Name(s)
Ampion
Intervention Description
Ampion, nebulized for inhalation
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
Incidence and severity of adverse events
Time Frame
Day 5
Title
Incidence and severity of adverse events
Description
Incidence and severity of adverse events
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Clinical status using 8-point ordinal scale
Description
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
Time Frame
Day 5
Title
Clinical status using 8-point ordinal scale
Description
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
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, ≥ 18 years old. 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. 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 A signed informed consent form from the patient or the patient's legal representative must be available. Exclusion Criteria: 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. Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.). Patient is on chronic immunosuppressive medication. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study. 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). Patient has known pregnancy or is currently breastfeeding. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use). Baseline QT prolongation.
Facility Information:
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34775578
Citation
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.
Results Reference
derived

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

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