A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19

Study Overview
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Brief Summary
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This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with respiratory distress due to COVID-19

Detailed Description
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The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the pandemic spread of coronavirus disease 2019 (COVID-19), which has a high rate of infection, has a high rate of hospitalization, has overwhelmed healthcare systems, and can be fatal. Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels. Ampion has the potential to improve clinical outcomes for COVID-19 patients by reducing inflammatory cytokines correlated with the disease and respiratory complications, such as Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). This study aims to evaluate the effects of Ampion on mortality and clinical outcomes in patients with respiratory distress due to COVID-19.

Official Title
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A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Biological: Ampion
* Other: Placebo


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 laboratory diagnostic test or diagnosis based on radiological clinical findings. Baseline severity categorization of severe or critical COVID-19 infection per FDA Guidance for developing drugs and biological products for COVID-19 (February 2021): Severe COVID-19: Symptoms suggestive of severe systemic illness with COVID-19, which could include shortness of breath or respiratory distress Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at or PaO2/FiO2 < 300 Critical COVID-19: Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced cannula at flow rates > 20 L/min with fraction of oxygen ≥ 0.5) or Non-invasive mechanical or endotracheal mechanical ventilation Informed consent obtained from the patient or the patient's legal representative. Exclusion Criteria: As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. Clinical diagnosis of respiratory failure requiring ECMO and/or therapy is not available due to limitation. Shock defined by systolic blood pressure <90 mm Hg, or diastolic blood pressure <60 mm Hg or requiring vasopressors. Multi-organ dysfunction/failure. Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). Patient has chronic conditions requiring chemotherapy or immunosuppressive medication. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (N- acetyltryptophan, sodium caprylate). Prolonged QT interval. Patient has known pregnancy or is currently breastfeeding. Patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Ampion | Biological: Ampion<br>* Inhaled Ampion<br>|
| Placebo Comparator: Control<br>Placebo | Other: Placebo<br>* Inhaled Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement of Participants of Ampion Compared to Placebo | Change in ordinal scale from baseline through Day 5 and through Day 28. The WHO's 8 point ordinal scale reflects the highest level of support the subject required on the day being recorded. 0 = No clinical or virological evidence of infection; 1 = no limitation of activities; 2 = limitation of activities; 3 = Hospitalized, no oxygen; 4 = Hospitalized, oxygen by mask or nasal prongs; 5 = Hospitalized, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, mechanical ventilation; 7 = Hospitalized, ventilation + additional organ support - pressors, RRT, ECMO; 8 = Death. A negative difference in mean score constitutes a reduction in the severity of clinical intervention. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. | Day 60 |