Trial · NCT04868890

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

NCT04868890, Phase 2, Terminated, Ampio Pharmaceuticals. Inc.; results first posted 2022-12-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19. Trials, record NCT04868890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04868890

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19
NCT number: NCT04868890
Status: Terminated
Phases: Phase 2
Enrollment: 200 participants, actual
Lead sponsor: Ampio Pharmaceuticals. Inc.
Conditions: Covid19
Interventions: Ampion, Placebo
First posted: 2021-05-03
Last updated: 2022-12-07
Results first posted: 2022-12-07
Limitations and caveats: The AP-019 study was prematurely terminated by the sponsor after determining that insufficient events were occurring to analyze the primary endpoint.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Improvement of Participants of Ampion Compared to Placebo	Day 28	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.
Secondary	The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Day 60	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Improvement of Participants of Ampion Compared to Placebo	Day 28	Intent to Treat (ITT)	score on a scale	MEAN
SECONDARY	The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Day 60	Safety	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Clinical Improvement of Participants of Ampion Compared to Placebo	Active	Day 5	-0.5	Standard Deviation 0.95	score on a scale
Clinical Improvement of Participants of Ampion Compared to Placebo	Control	Day 5	-0.4	Standard Deviation 0.73	score on a scale
Clinical Improvement of Participants of Ampion Compared to Placebo	Active	Day 28	-4.1	Standard Deviation 0.63	score on a scale
Clinical Improvement of Participants of Ampion Compared to Placebo	Control	Day 28	-4.0	Standard Deviation 0.49	score on a scale
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Active	Treatment Emergent Adverse Events (TEAE's)	21		Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Control	Treatment Emergent Adverse Events (TEAE's)	18		Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Active	Study Drug Related TEAE's	0		Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Control	Study Drug Related TEAE's	1		Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Active	Moderate or Severe TEAE's	10		Participants
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo	Control	Moderate or Severe TEAE's	11		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active	64
Overall Study	STARTED	Control	65
Overall Study	COMPLETED	Active	61
Overall Study	COMPLETED	Control	59
Overall Study	NOT COMPLETED	Active	3
Overall Study	NOT COMPLETED	Control	6

Source ClinicalTrials.gov

Adverse events92

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Discomfort	Gastrointestinal disorders	Active	2	64	2
other	Abdominal Discomfort	Gastrointestinal disorders	Control	0	65	0
other	Constipation	Gastrointestinal disorders	Active	2	64	2
other	Constipation	Gastrointestinal disorders	Control	1	65	1
other	Asthenia	General disorders	Active	2	64	2
other	Asthenia	General disorders	Control	2	65	2
other	Fatigue	General disorders	Active	4	64	4
other	Fatigue	General disorders	Control	1	65	1
other	Pain	General disorders	Active	2	64	2
other	Pain	General disorders	Control	2	65	2

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active	2	64
Total, all-cause mortality	Control	1	65
Total, other adverse events	Active	21	64
Total, other adverse events	Control	18	65
Total, serious adverse events	Active	2	64
Total, serious adverse events	Control	4	65

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active vs Control: deaths from any cause	Trial comparisons
Active vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04868890

GET https://conductscience.org/api/trials/v1/NCT04868890/events?page=2

API reference For AI assistants