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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Biological: Ampion
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ampion<br>Ampion | Biological: Ampion<br>* Ampion, nebulized for inhalation<br>Other: Standard of Care<br>* Standard of Care<br>|
| Other: Standard of Care<br>Standard of Care | Other: Standard of Care<br>* Standard of Care<br>|

What is the study measuring?
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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 |