Covid19
Conditions
Brief summary
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.
Interventions
BIOLOGICALAmpion
Ampion, nebulized for inhalation
OTHERStandard of Care
Standard of Care
Sponsors
Ampio Pharmaceuticals. Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events | Day 5 | Incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical status using 8-point ordinal scale | Day 5 | Efficacy measures for clinical improvement using 8-point ordinal scale: 0 = Uninfected, 1 = Ambulatory without limitation of activity, 2 = Ambulatory with limitation of activity, 3 = Hospitalized mild disease, no oxygen, 4 = Hospitalized mild disease, supplemental oxygen, 5 = Hospitalized severe disease, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized severe disease, intubation and mechanical ventilation, 7 = Hospitalized severe disease, ventilation plus additional organ support, 8 = Death |
Countries
United States
Outcome results
None listed