Status:
TERMINATED
A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19
Lead Sponsor:
Ampio Pharmaceuticals. Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with respiratory distress due to COVID-19
Detailed Description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the pandemic spread of coronavirus disease 2019 (COVID-19), which has a high rate of infection, has a high rate of hosp...
Eligibility Criteria
Inclusion
- Male or female, ≥ 18 years old
- Diagnosed with COVID-19, as evaluated by laboratory diagnostic test or diagnosis based on radiological clinical findings.
- Baseline severity categorization of severe or critical COVID-19 infection per FDA Guidance for developing drugs and biological products for COVID-19 (February 2021):
- 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
- 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
- Informed consent obtained from the patient or the patient's legal representative.
Exclusion
- 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.
- Clinical diagnosis of respiratory failure requiring ECMO and/or therapy is not available due to limitation.
- Shock defined by systolic blood pressure \<90 mm Hg, or diastolic blood pressure \<60 mm Hg or requiring vasopressors.
- Multi-organ dysfunction/failure.
- 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.).
- Patient has chronic conditions requiring chemotherapy or immunosuppressive medication.
- 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).
- Prolonged QT interval.
- Patient has known pregnancy or is currently breastfeeding.
- 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.
- 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).
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04868890
Start Date
June 22 2021
End Date
April 13 2022
Last Update
December 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ampio Pharmaceuticals
Englewood, Colorado, United States, 80112