Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress

Inclusion criteria

• Male or female, ≥ 18 years old.
• Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.
• Respiratory distress as evidenced by at least two of the following:

• Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
• Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90%
• Requiring supplemental oxygen
• Diagnosis of mild, moderate, or severe ARDS by Berlin definition
• 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 within the next 24 hours, irrespective of the provision of treatments.
• Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
• 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 (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
• Baseline QT prolongation.