A study of Ampion in adults with respiratory distress due to COVID-19.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/09/036828
- Lead Sponsor
- Ampio Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 69
1. Male or female, � 18 years old
2. Diagnosed with SARS-CoV2, as confirmed using a standard RT-PCT assay or an equivalent test.
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):
a) 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.
b) Critical COVID-19:
� Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered
� Non-invasive mechanical or endotracheal mechanical ventilation via reinforced cannula at flow rates > 20 L/min with fraction of oxygen � 0.5)
4. Informed consent obtained from the patient or the patients legal representative
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with a successful outcome (life) or unsuccessful outcome (death) by Day 28.Timepoint: To be assessed by Day 28
- Secondary Outcome Measures
Name Time Method Change in baseline in oxygen use, blood oxygen saturation, and oxygen flow rateTimepoint: To be assessed from baseline through Day 5.;Change in NEWS2 score <br/ ><br> <br/ ><br>Modulation of cytokine levelsTimepoint: To be assessed from baseline to Day 5. <br/ ><br>;Change in ordinal scaleTimepoint: To be assessed from baseline through Day 5.;Hospital length of stay (LOS)Timepoint: From admission (baseline) to discharge;Incidence of adverse events (AEs) and serious adverse events (SAEs)Timepoint: To be assessed from baseline to day 60;Percentage of participants who progress to respiratory failure (i.e., need for mechanical ventilation, ECMO, non-invasive ventilation)Timepoint: To be assessed by day 28.;Percentage of participants who require Intensive Care Unit (ICU)Timepoint: To be assessed by day 28 <br/ ><br> <br/ ><br>