Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress

NCT04606784 | Completed Phase 1 FDA Drug

• 1 other identifier: AP-014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events

  Incidence and severity of adverse events

  Day 5

• Incidence and severity of adverse events

  Incidence and severity of adverse events

  Day 28

Secondary Outcomes (2)

• Clinical status using 8-point ordinal scale

  Day 5

• Clinical status using 8-point ordinal scale

  Day 28

Study Arms (2)

Ampion

EXPERIMENTAL

Ampion

Biological: Ampion; Other: Standard of Care

Standard of Care

OTHER

Standard of Care

Other: Standard of Care

Interventions

Ampion BIOLOGICAL

Ampion, nebulized for inhalation

Ampion

Standard of Care OTHER

Standard of Care

Ampion; Standard of Care

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 PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.
• Respiratory distress as evidenced by at least two of the following:
• Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
• Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90%
• Requiring supplemental oxygen
• Diagnosis of mild, moderate, or severe ARDS by Berlin definition
• A signed informed consent form from the patient or the patient's legal representative must be available.

You may not qualify if:

• In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
• Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
• Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
• Patient is on chronic immunosuppressive medication.
• As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
• Patient has known pregnancy or is currently breastfeeding.
• Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
• Baseline QT prolongation.

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Research Site

Colorado Springs, Colorado, 80907, United States

Location

Related Publications (1)

• Roshon M, Lemos-Filho L, Cherevka H, Goldberg L, Salottolo K, Bar-Or D. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of a Novel Inhaled Biologic Therapeutic in Adults with Respiratory Distress Secondary to COVID-19 Infection. Infect Dis Ther. 2022 Feb;11(1):595-605. doi: 10.1007/s40121-021-00562-z. Epub 2021 Nov 14.

  PMID: 34775578 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

aspartyl-alanyl-diketopiperazine; Standard of Care

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)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: October 28, 2020
• Study Start: October 28, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)