COVID-19
Conditions
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.
Interventions
BIOLOGICALAmpion
Ampion, administered by intravenous infusion
OTHERStandard of Care
Standard of Care
Sponsors
Ampio Pharmaceuticals. Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events | Primary endpoint at day 5 | Incidence and severity of adverse events |
Countries
United States
Outcome results
None listed