Trial Outcomes & Findings for A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID) (NCT NCT04880161)

Last Updated: 2023-09-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Baseline to Day 28

Results posted on

2023-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Active Ampion Ampion: Inhaled nebulized Ampion (8 mL) administered four times daily, every four to six hours, for five days.	Control Placebo Placebo: Inhaled nebulized saline (8 mL) administered four times daily, every four to six hours, for five days.
Overall Study STARTED	16	16
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Ampion Ampion: Inhaled nebulized Ampion (8 mL) administered four times daily, every four to six hours, for five days.	Control Placebo Placebo: Inhaled nebulized saline (8 mL) administered four times daily, every four to six hours, for five days.
Overall Study Withdrawal by Subject	1	0
Overall Study Lack of Compliance	1	1
Overall Study Incorrectly Randomized followed for Safety	0	1
Overall Study Screen Failure	0	1

Baseline Characteristics

A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=16 Participants Ampion Ampion: Inhaled nebulized Ampion (8 mL) administered four times daily, every four to six hours, for five days.	Control n=16 Participants Placebo Placebo: Inhaled nebulized saline (8 mL) administered four times daily, every four to six hours, for five days.	Total n=32 Participants Total of all reporting groups
Age, Continuous	49.0 years STANDARD_DEVIATION 11.9 • n=5 Participants	55.1 years STANDARD_DEVIATION 13.7 • n=7 Participants	52.1 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	14 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	11 Participants n=7 Participants	22 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Body Mass Index (BMI)	32.6 kg/m^2 STANDARD_DEVIATION 7.4 • n=5 Participants	34.1 kg/m^2 STANDARD_DEVIATION 7.0 • n=7 Participants	33.4 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

Population: Safety Population - one participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.

Outcome measures

Outcome measures
Measure	Active n=15 Participants Ampion Ampion: Inhaled nebulized Ampion (8 mL) administered four times daily, every four to six hours, for five days.	Control n=16 Participants Placebo Placebo: Inhaled nebulized saline (8 mL) administered four times daily, every four to six hours, for five days.
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Subjects with Treatment Emergent Adverse Events (TEAE's)	5 Participants	9 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Subjects with Study Drug Related TEAE's	3 Participants	5 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Subjects with Moderate or Severe TEAE's	1 Participants	5 Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Subjects with SAE's	0 Participants	0 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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=15 participants at risk Ampion Ampion: Inhaled nebulized Ampion (8 mL) administered four times daily, every four to six hours, for five days.	Control n=16 participants at risk Placebo Placebo: Inhaled nebulized saline (8 mL) administered four times daily, every four to six hours, for five days.
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Gastrointestinal disorders Dyspepsia	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Gastrointestinal disorders Paraesthesia Oral	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Gastrointestinal disorders Vomiting	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
General disorders Asthenia	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
General disorders Chills	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
General disorders Fatigue	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
General disorders Pyrexia	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Immune system disorders Hypersensitivity	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Infections and infestations Nasopharyngitis	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Injury, poisoning and procedural complications Fall	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Musculoskeletal and connective tissue disorders Myalgia	13.3% 2/15 • Number of events 2 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Musculoskeletal and connective tissue disorders Pain in Jaw	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Nervous system disorders Headache	13.3% 2/15 • Number of events 2 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	12.5% 2/16 • Number of events 2 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Nervous system disorders Paraesthesia	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Nervous system disorders Somnolence	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Respiratory, thoracic and mediastinal disorders Wheezing	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Skin and subcutaneous tissue disorders Skin Ulcer	6.7% 1/15 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	0.00% 0/16 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Psychiatric disorders Alcohol Abuse	0.00% 0/15 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.	6.2% 1/16 • Number of events 1 • Baseline to Day 60 Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.