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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606784
• Other study ID #: AP-014
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: March 2022
• Source: Ampio Pharmaceuticals. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Ampion
Ampion, nebulized for inhalation

Other:
• Standard of Care
Standard of Care

Locations

Country	Name	City	State
United States	Research Site	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Ampio Pharmaceuticals. Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events	Incidence and severity of adverse events	Day 5
Primary	Incidence and severity of adverse events	Incidence and severity of adverse events	Day 28
Secondary	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
Secondary	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