Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Ampion; Saline
Intervention description: Ampion administered via intravenous infusion; Placebo administered via intravenous infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in
      improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental
      oxygen.
    

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 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 sea level (SpO2 ≤ 90% at altitude) 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
                       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 (therapy not able to be administered in
             setting of resource 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).