Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen

NCT04839965 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AP-017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental oxygen.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Occurrence of Mechanical Ventilation or Death

  Assess the effect of Ampio compared to placebo on prevention of need for mechanical ventilation or death. This is measured as the occurrence of subjects on mechanical ventilation or death by day 28.

  Day 28

Secondary Outcomes (1)

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

  Baseline to Day 60

Study Arms (2)

IV Ampion

EXPERIMENTAL

Ampion administered via intravenous infusion

Biological: Ampion

IV placebo

PLACEBO COMPARATOR

Placebo administered via intravenous infusion

Other: Saline

Interventions

Ampion BIOLOGICAL

Ampion administered via intravenous infusion

IV Ampion

Saline OTHER

Placebo administered via intravenous infusion

IV placebo

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 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 sea level (SpO2 ≤ 90% at altitude) 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 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 (therapy not able to be administered in setting of resource 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; Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The AP-017 study was prematurely terminated by the sponsor after an interim analysis.

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 9, 2021
• Study Start: July 5, 2021
• Primary Completion: February 7, 2022
• Study Completion: April 4, 2022
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-03

Locations

US (1)