Trial Outcomes & Findings for Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen (NCT NCT04839965)

Last Updated: 2022-11-30

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Day 28

Results posted on

2022-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	IV Ampion Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days.	IV Placebo Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days.
Overall Study STARTED	21	15
Overall Study COMPLETED	14	9
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Ampion Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days.	IV Placebo Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days.
Overall Study Death	6	6
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Ampion n=21 Participants Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days.	IV Placebo n=15 Participants Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days.	Total n=36 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 10.0 • n=99 Participants	53.4 years STANDARD_DEVIATION 15.0 • n=107 Participants	55.4 years STANDARD_DEVIATION 12.3 • n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	2 Participants n=107 Participants	9 Participants n=206 Participants
Sex: Female, Male Male	14 Participants n=99 Participants	13 Participants n=107 Participants	27 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=99 Participants	12 Participants n=107 Participants	32 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	18 Participants n=99 Participants	14 Participants n=107 Participants	32 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	21 participants n=99 Participants	15 participants n=107 Participants	36 participants n=206 Participants
Body Mass Index (BMI)	37.3 kg/m^2 STANDARD_DEVIATION 13.7 • n=99 Participants	31.4 kg/m^2 STANDARD_DEVIATION 6.8 • n=107 Participants	34.9 kg/m^2 STANDARD_DEVIATION 11.6 • n=206 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Intent to Treat (ITT)

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.

Outcome measures

Outcome measures
Measure	IV Ampion n=21 Participants Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days.	IV Placebo n=15 Participants Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days.
Number of Participants With Occurrence of Mechanical Ventilation or Death	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline to Day 60

Population: Intent to Treat (ITT)

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.

Outcome measures

Outcome measures
Measure	IV Ampion n=21 Participants Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days.	IV Placebo n=15 Participants Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days.
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Moderate or Severe TEAE's	12 Participants	8 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Treatment Emergent Adverse Events (TEAE's)	15 Participants	12 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Study Drug Related TEAE's	0 Participants	3 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Serious Adverse Events	11 Participants	8 Participants

Adverse Events

IV Ampion

Serious events: 11 serious events

Other events: 15 other events

Deaths: 6 deaths

IV Placebo

Serious events: 8 serious events

Other events: 12 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Howard Levy / Chief Medical Officer

Ampio Pharmaceuticals

Phone: 17204376500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IV Ampion n=21 participants at risk Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days.	IV Placebo n=15 participants at risk Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days.
Cardiac disorders Atrial Fibrillation	0.00% 0/21 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	6.7% 1/15 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Cardiac disorders Cardiac Arrest	0.00% 0/21 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	26.7% 4/15 • Number of events 4 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Cardiac disorders Cardio Respiratory Arrest	0.00% 0/21 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	6.7% 1/15 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Cardiac disorders Myocardial Infarction	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Cardiac disorders Ventricular Tachycardia	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
General disorders Organ Failure	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Infections and infestations Bacteraemia	0.00% 0/21 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	6.7% 1/15 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Infections and infestations COVID-19 Pneumonia	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Infections and infestations Perirectal Abscess	0.00% 0/21 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	6.7% 1/15 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Infections and infestations Pneumonia Bacterial	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Infections and infestations Septic Shock	9.5% 2/21 • Number of events 2 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	20.0% 3/15 • Number of events 3 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Renal and urinary disorders Acute Kidney Injury	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Renal and urinary disorders Renal Failure	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Renal and urinary disorders Renal Impairment	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	28.6% 6/21 • Number of events 6 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	20.0% 3/15 • Number of events 3 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Aspiration	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax Spontaneous	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	6.7% 1/15 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/21 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	6.7% 1/15 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	14.3% 3/21 • Number of events 3 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	6.7% 1/15 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Vascular disorders Hypotension	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Vascular disorders Shock	4.8% 1/21 • Number of events 1 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/15 • 60 days Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.