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

NCT04868890 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AP-019
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement of Participants of Ampion Compared to Placebo

  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.

  Day 28

Secondary Outcomes (1)

• The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo

  Day 60

Study Arms (2)

Active

EXPERIMENTAL

Ampion

Biological: Ampion

Control

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Ampion BIOLOGICAL

Inhaled Ampion

Active

Placebo OTHER

Inhaled Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥ 18 years old
• Diagnosed with COVID-19, as evaluated by laboratory diagnostic test or diagnosis based on radiological clinical findings.
• Baseline severity categorization of severe or critical COVID-19 infection per FDA Guidance for developing drugs and biological products for COVID-19 (February 2021):
• Severe COVID-19:
• Symptoms suggestive of severe systemic illness with COVID-19, which could include shortness of breath or respiratory distress
• Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at or PaO2/FiO2 \< 300
• Critical COVID-19:
• Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced cannula at flow rates \> 20 L/min with fraction of oxygen ≥ 0.5) or
• Non-invasive mechanical or endotracheal mechanical ventilation
• Informed consent obtained from the patient or the patient's legal representative.

You may not qualify if:

• As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments.
• Clinical diagnosis of respiratory failure requiring ECMO and/or therapy is not available due to limitation.
• Shock defined by systolic blood pressure \<90 mm Hg, or diastolic blood pressure \<60 mm Hg or requiring vasopressors.
• Multi-organ dysfunction/failure.
• Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.).
• Patient has chronic conditions requiring chemotherapy or immunosuppressive medication.
• Prolonged QT interval.
• Patient has known pregnancy or is currently breastfeeding.
• Patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception.
• Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Ampio Pharmaceuticals

Englewood, Colorado, 80112, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

aspartyl-alanyl-diketopiperazine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

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.

Results Point of Contact

• Title: Dr. Howard Levy / Chief Medical Officer
• Organization: Ampio Pharmaceuticals

clinicaltrials@ampiopharma.com

17204376500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 3, 2021
• Study Start: June 22, 2021
• Primary Completion: February 16, 2022
• Study Completion: April 13, 2022
• Last Updated: December 7, 2022
• Results First Posted: December 7, 2022

Record last verified: 2022-05

Locations

US (1)