A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: Ampion; Placebo
Intervention description: Inhaled Ampion; Inhaled Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with
      respiratory distress due to COVID-19
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, ≥ 18 years old

          2. Diagnosed with COVID-19, as evaluated by laboratory diagnostic test or diagnosis based
             on radiological clinical findings.

          3. Baseline severity categorization of severe or critical COVID-19 infection per FDA
             Guidance for developing drugs and biological products for COVID-19 (February 2021):

               1. Severe COVID-19:

                    -  Symptoms suggestive of severe systemic illness with COVID-19, which could
                       include shortness of breath or respiratory distress

                    -  Clinical signs indicative of severe systemic illness with COVID-19, such as
                       respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on
                       room air at or PaO2/FiO2 < 300

               2. Critical COVID-19:

                    -  Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen
                       delivered via reinforced cannula at flow rates > 20 L/min with fraction of
                       oxygen ≥ 0.5) or

                    -  Non-invasive mechanical or endotracheal mechanical ventilation

          4. Informed consent obtained from the patient or the patient's legal representative.

        Exclusion Criteria:

          1. As a result of the medical review and screening investigation, the Principal
             Investigator considers the patient unfit for the study and/or progression to death is
             imminent and inevitable irrespective of the provision of treatments.

          2. Clinical diagnosis of respiratory failure requiring ECMO and/or therapy is not
             available due to limitation.

          3. Shock defined by systolic blood pressure <90 mm Hg, or diastolic blood pressure <60 mm
             Hg or requiring vasopressors.

          4. Multi-organ dysfunction/failure.

          5. Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) (as
             defined by prior pulmonary function tests), chronic renal failure, or significant
             liver abnormality (e.g., cirrhosis, transplant, etc.).

          6. Patient has chronic conditions requiring chemotherapy or immunosuppressive medication.

          7. A history of allergic reactions to human albumin (reaction to non-human albumin such
             as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (N-
             acetyltryptophan, sodium caprylate).

          8. Prolonged QT interval.

          9. Patient has known pregnancy or is currently breastfeeding.

         10. Patient planning to become pregnant, or father a child, during the treatment and
             follow-up period and/or is not willing to remain abstinent or use contraception.

         11. Participation in another clinical trial (not including treatments for COVID-19 as
             approved by the FDA through expanded access, emergency, or compassionate use), or
             participation in a trial such that enrollment in this study would fall within the time
             frame of the half-life of the other investigational product(s).