COVID-19
Conditions
Brief 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.
Detailed description
Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels. Ampion has the potential to improve clinical outcomes for COVID-19 patients by reducing inflammatory cytokines correlated with the disease. This study aims to evaluate Ampion and clinical outcomes in patients with COVID-19 requiring supplemental oxygen.
Interventions
BIOLOGICALAmpion
Ampion administered via intravenous infusion
OTHERSaline
Placebo administered via intravenous infusion
Sponsors
Ampio Pharmaceuticals. Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Occurrence of Mechanical Ventilation or Death | Day 28 | Assess the effect of Ampio compared to placebo on prevention of need for mechanical ventilation or death. This is measured as the occurrence of subjects on mechanical ventilation or death by day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Baseline to Day 60 | Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of IV Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Ampion Ampion administered via intravenous infusion
Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days. | 21 |
| IV Placebo Placebo administered via intravenous infusion
Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days. | 15 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 6 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | IV Ampion | IV Placebo | Total |
|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 10 | 53.4 years STANDARD_DEVIATION 15 | 55.4 years STANDARD_DEVIATION 12.3 |
| Body Mass Index (BMI) | 37.3 kg/m^2 STANDARD_DEVIATION 13.7 | 31.4 kg/m^2 STANDARD_DEVIATION 6.8 | 34.9 kg/m^2 STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 12 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 14 Participants | 32 Participants |
| Region of Enrollment United States | 21 participants | 15 participants | 36 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 21 | 6 / 15 |
| other Total, other adverse events | 15 / 21 | 12 / 15 |
| serious Total, serious adverse events | 11 / 21 | 8 / 15 |
Outcome results
Primary
Number of Participants With Occurrence of Mechanical Ventilation or Death
Assess the effect of Ampio compared to placebo on prevention of need for mechanical ventilation or death. This is measured as the occurrence of subjects on mechanical ventilation or death by day 28.
Time frame: Day 28
Population: Intent to Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Ampion | Number of Participants With Occurrence of Mechanical Ventilation or Death | 5 Participants |
| IV Placebo | Number of Participants With Occurrence of Mechanical Ventilation or Death | 5 Participants |
Secondary
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo
Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of IV Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
Time frame: Baseline to Day 60
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ampion | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Moderate or Severe TEAE's | 12 Participants |
| IV Ampion | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Study Drug Related TEAE's | 0 Participants |
| IV Ampion | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Serious Adverse Events | 11 Participants |
| IV Ampion | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Treatment Emergent Adverse Events (TEAE's) | 15 Participants |
| IV Placebo | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Serious Adverse Events | 8 Participants |
| IV Placebo | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Treatment Emergent Adverse Events (TEAE's) | 12 Participants |
| IV Placebo | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Study Drug Related TEAE's | 3 Participants |
| IV Placebo | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Moderate or Severe TEAE's | 8 Participants |