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

Phase 1

Completed

• Conditions: Covid19
• Interventions: Biological: Ampion; Other: Standard of Care

• Registration Number: NCT04606784
• Lead Sponsor: Ampio Pharmaceuticals. Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study Start: 2020-10-28
• Study First Posted: 2020-10-28
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ampion	Ampion	Ampion
Ampion	Standard of Care	Ampion
Standard of Care	Standard of Care	Standard of Care

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	Day 28	Incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Clinical status using 8-point ordinal scale	Day 28	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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Colorado Springs, Colorado, United States