Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ampion
Saline
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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).
Sites / Locations
- Ampio Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IV Ampion
IV placebo
Arm Description
Ampion administered via intravenous infusion
Placebo administered via intravenous infusion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04839965
First Posted
April 8, 2021
Last Updated
November 9, 2022
Sponsor
Ampio Pharmaceuticals. Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04839965
Brief Title
Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The AP-017 study was prematurely terminated by the sponsor after an interim analysis.
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ampio Pharmaceuticals. Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV Ampion
Arm Type
Experimental
Arm Description
Ampion administered via intravenous infusion
Arm Title
IV placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered via intravenous infusion
Intervention Type
Biological
Intervention Name(s)
Ampion
Intervention Description
Ampion administered via intravenous infusion
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Placebo administered via intravenous infusion
Primary Outcome Measure Information:
Title
Number of Participants With Occurrence of Mechanical Ventilation or Death
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo
Description
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.
Time Frame
Baseline to Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Ampio Pharmaceuticals
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen
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