Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ampion Ampion |
Biological: Ampion
Ampion, administered by intravenous infusion
Other: Standard of Care
Standard of Care
|
| Other: Standard of Care Standard of Care |
Other: Standard of Care
Standard of Care
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events [Primary endpoint at day 5]
Incidence and severity of adverse events
Eligibility Criteria
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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Colorado Springs | Colorado | United States | 80907 |
Sponsors and Collaborators
- Ampio Pharmaceuticals. Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AP-016