This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.
Biological: Ampion
Ampion, nebulized for inhalation
Other: Standard of Care
Standard of Care
Inclusion Criteria:
1. Male or female, ≥ 18 years old.
2. 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.
3. 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
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
within the next 24 hours, irrespective of the provision of treatments.
2. Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
3. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal
failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
4. Patient is on chronic immunosuppressive medication.
5. As a result of the medical review and screening investigation, the Principal
Investigator considers the patient unfit for the study.
6. 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).
7. Patient has known pregnancy or is currently breastfeeding.
8. Participation in another clinical trial (not including treatments for COVID-19 as
approved by the FDA through expanded access or compassionate use).
9. Baseline QT prolongation.
Research Site
Colorado Springs, Colorado, United States