Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen

Study Overview
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Brief Summary
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This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental oxygen.

Detailed Description
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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. This study aims to evaluate Ampion and clinical outcomes in patients with COVID-19 requiring supplemental oxygen.

Official Title
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A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Ampion
* Other: Saline


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 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 sea level (SpO2 ≤ 90% at altitude) 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 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 (therapy not able to be administered in setting of resource 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Ampion<br>Ampion administered via intravenous infusion | Biological: Ampion<br>* Ampion administered via intravenous infusion<br>|
| Placebo Comparator: IV placebo<br>Placebo administered via intravenous infusion | Other: Saline<br>* Placebo administered via intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Occurrence of Mechanical Ventilation or Death | Assess the effect of Ampio compared to placebo on prevention of need for mechanical ventilation or death. This is measured as the occurrence of subjects on mechanical ventilation or death by day 28. | 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 IV 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. | Baseline to Day 60 |