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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female, 18 years to 89 years old (inclusive). 2. Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2. 3. Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion). 4. A signed informed consent form from the patient or the patient's legal representative must be available.

Exclusion Criteria

  1. In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments. 2. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.). 3. Patient is on chronic immunosuppressive medication. 4. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study. 5. 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). 6. Patient has known pregnancy or is currently breastfeeding. 7. Participation in another clinical trial. 8. Baseline QT prolongation.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04456452
Status
Completed
Sponsor
Ampio Pharmaceuticals. Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.