Back to resultsStudy of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ampion
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 years to 89 years old (inclusive).
- Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2.
- Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).
- 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, irrespective of the provision of treatments.
- 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.
- Baseline QT prolongation.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Ampion
Standard of Care
Arm Description
Ampion
Standard of Care
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events
Incidence and severity of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT04456452
First Posted
June 30, 2020
Last Updated
January 12, 2021
Sponsor
Ampio Pharmaceuticals. Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04456452
Brief Title
Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
Official Title
A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
September 8, 2020 (Actual)
Study Completion Date
November 30, 2020 (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
5. Study Description
Brief Summary
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require 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 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ampion
Arm Type
Experimental
Arm Description
Ampion
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Standard of Care
Intervention Type
Biological
Intervention Name(s)
Ampion
Intervention Description
Ampion, administered by intravenous infusion
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
Incidence and severity of adverse events
Time Frame
Primary endpoint at day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 years to 89 years old (inclusive).
Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2.
Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).
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, irrespective of the provision of treatments.
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.
Baseline QT prolongation.
Facility Information:
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
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