Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation

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.