NCT04868890

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

Terminated Phase 2 Results posted Last updated 7 December 2022

What this trial tests

Phase 2 trial testing Ampion in Covid19 in 200 participants. Terminated before completion.

Timeline

22 June 2021

Primary endpoint
16 February 2022

13 April 2022

Quick facts

Lead sponsor	Ampio Pharmaceuticals. Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	200
Start date	22 June 2021
Primary completion	16 February 2022
Estimated completion	13 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Ampion — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Ampio Pharmaceuticals. Inc. — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Improvement of Participants of Ampion Compared to Placebo Primary · 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 differ

Day 5

Group	Value	95% CI
Active	-0.5	± 0.95
Control	-0.4	± 0.73

Day 28

Group	Value	95% CI
Active	-4.1	± 0.63
Control	-4.0	± 0.49

The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo Secondary · 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.

Treatment Emergent Adverse Events (TEAE's)

Group	Value	95% CI
Active	21
Control	18

Study Drug Related TEAE's

Group	Value	95% CI
Active	0
Control	1

Moderate or Severe TEAE's

Group	Value	95% CI
Active	10
Control	11

Serious Adverse Events (SAE's)

Group	Value	95% CI
Active	2
Control	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 60. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active

Serious: 2/64 (3%)

Deaths: 2/64

Control

Serious: 4/65 (6%)

Deaths: 1/65

Serious adverse events (4 terms)

Reaction	System	Active	Control
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	—	—
Chest Pain	General disorders	—	—
Sepsis	Infections and infestations	—	—
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (42 terms — click to expand)

Reaction	System	Active	Control
Fatigue	General disorders	—	—
Pyrexia	General disorders	—	—
Blood Urea Abnormal	Investigations	—	—
Headache	Nervous system disorders	—	—
Abdominal Discomfort	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Pain	General disorders	—	—
Alanine Aminotransferase Increased	Investigations	—	—
Blood Lactate Dehydrogenase Increased	Investigations	—	—
C-Reactive Protein Increased	Investigations	—	—
Platelet Count Abnormal	Investigations	—	—
Serum Ferritin Increased	Investigations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Aspartate Aminotransferase Increased	Investigations	—	—
Blood Bicarbonate Abnormal	Investigations	—	—
Blood Creatine Abnormal	Investigations	—	—
Blood Creatine Increased	Investigations	—	—
Blood Potassium Abnormal	Investigations	—	—
Blood Sodium Abnormal	Investigations	—	—
Electrocardiogram QT Prolonged	Investigations	—	—
Lymphocyte Count Decreased	Investigations	—	—
Neutrophil Count Increased	Investigations	—	—
White Blood Cell Count Abnormal	Investigations	—	—
White Blood Cell Count Increased	Investigations	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	—	—
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Memory Impairment	Nervous system disorders	—	—
Insomnia	Psychiatric disorders	—	—
Haematuria	Renal and urinary disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Hiccups	Respiratory, thoracic and mediastinal disorders	—	—
Nasal Discomfort	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Acute Respiratory Distress Syndrome, Chest Pain, Sepsis, Pulmonary Embolism.

Data from ClinicalTrials.gov NCT04868890 adverse events section.

Sponsor's own description

This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with respiratory distress due to COVID-19

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A roadmap to pulmonary delivery strategies for the treatment of infectious lung diseases.
   He S, Gui J, Xiong K, Chen M, et al · · 2022 · cited 91× · PMID 35241085 · DOI 10.1186/s12951-022-01307-x