Trial Outcomes & Findings for A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19 (NCT NCT04868890)

Last Updated: 2022-12-07

Results Overview

Change in ordinal scale from baseline through Day 5 and through Day 28. The WHO's 8 point ordinal scale reflects the highest level of support the subject required on the day being recorded. 0 = No clinical or virological evidence of infection; 1 = no limitation of activities; 2 = limitation of activities; 3 = Hospitalized, no oxygen; 4 = Hospitalized, oxygen by mask or nasal prongs; 5 = Hospitalized, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, mechanical ventilation; 7 = Hospitalized, ventilation + additional organ support - pressors, RRT, ECMO; 8 = Death. A negative difference in mean score constitutes a reduction in the severity of clinical intervention.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

Day 28

Results posted on

2022-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	Active Ampion Ampion: Inhaled Ampion (8mL) administered four times daily for 5 days	Control Placebo Placebo: Inhaled Placebo (8mL) administered four times daily for 5 days
Overall Study STARTED	64	65
Overall Study COMPLETED	61	59
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Ampion Ampion: Inhaled Ampion (8mL) administered four times daily for 5 days	Control Placebo Placebo: Inhaled Placebo (8mL) administered four times daily for 5 days
Overall Study Death	2	1
Overall Study Withdrawal by Subject	1	5

Baseline Characteristics

A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=64 Participants Ampion Ampion: Inhaled Ampion (8mL) administered four times daily for 5 days	Control n=65 Participants Placebo Placebo: Inhaled Placebo (8mL) administered four times daily for 5 days	Total n=129 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 15.2 • n=5 Participants	56.9 years STANDARD_DEVIATION 16.6 • n=7 Participants	54.9 years STANDARD_DEVIATION 16.0 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	32 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment India	36 participants n=5 Participants	33 participants n=7 Participants	69 participants n=5 Participants
Body Mass Index (BMI)	29.4 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants	28.5 kg/m^2 STANDARD_DEVIATION 5.4 • n=7 Participants	28.9 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Active n=64 Participants Ampion Ampion: Inhaled Ampion (8mL) administered four times daily for 5 days	Control n=65 Participants Placebo Placebo: Inhaled Placebo (8mL) administered four times daily for 5 days
Clinical Improvement of Participants of Ampion Compared to Placebo Day 5	-0.5 score on a scale Standard Deviation 0.95	-0.4 score on a scale Standard Deviation 0.73
Clinical Improvement of Participants of Ampion Compared to Placebo Day 28	-4.1 score on a scale Standard Deviation 0.63	-4.0 score on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: Day 60

Population: Safety

Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation 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	Active n=64 Participants Ampion Ampion: Inhaled Ampion (8mL) administered four times daily for 5 days	Control n=65 Participants Placebo Placebo: Inhaled Placebo (8mL) administered four times daily for 5 days
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Treatment Emergent Adverse Events (TEAE's)	21 Participants	18 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Study Drug Related TEAE's	0 Participants	1 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Moderate or Severe TEAE's	10 Participants	11 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Serious Adverse Events (SAE's)	2 Participants	4 Participants

Adverse Events

Active

Serious events: 2 serious events

Other events: 21 other events

Deaths: 2 deaths

Control

Serious events: 4 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Active n=64 participants at risk Ampion Ampion: Inhaled Ampion (8mL) administered four times daily for 5 days	Control n=65 participants at risk Placebo Placebo: Inhaled Placebo (8mL) administered four times daily for 5 days
General disorders Chest Pain	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Infections and infestations Sepsis	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 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	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 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% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.

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	Active n=64 participants at risk Ampion Ampion: Inhaled Ampion (8mL) administered four times daily for 5 days	Control n=65 participants at risk Placebo Placebo: Inhaled Placebo (8mL) administered four times daily for 5 days
Gastrointestinal disorders Abdominal Discomfort	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Gastrointestinal disorders Constipation	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
General disorders Asthenia	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	3.1% 2/65 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
General disorders Fatigue	6.2% 4/64 • Number of events 4 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
General disorders Pain	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	3.1% 2/65 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
General disorders Pyrexia	4.7% 3/64 • Number of events 3 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Alanine Aminotransferase Increased	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	3.1% 2/65 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Blood Lactate Dehydrogenase Increased	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Blood Urea Abnormal	4.7% 3/64 • Number of events 3 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	4.6% 3/65 • Number of events 3 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations C-Reactive Protein Increased	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Platelet Count Abnormal	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Serum Ferritin Increased	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Nervous system disorders Headache	4.7% 3/64 • Number of events 3 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	3.1% 2/65 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.1% 2/64 • Number of events 2 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Ear and labyrinth disorders Vertigo	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Aspartate Aminotransferase Increased	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Blood Bicarbonate Abnormal	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Blood Creatine Abnormal	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Blood Creatine Increased	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Blood Potassium Abnormal	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Blood Sodium Abnormal	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Electrocardiogram QT Prolonged	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Lymphocyte Count Decreased	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations Neutrophil Count Increased	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations White Blood Cell Count Abnormal	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Investigations White Blood Cell Count Increased	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Nervous system disorders Memory Impairment	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Renal and urinary disorders Haematuria	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/64 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	1.5% 1/65 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.
Vascular disorders Hypertension	1.6% 1/64 • Number of events 1 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.	0.00% 0/65 • Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication.