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COMPLETEDPHASE1

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

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Nebulized Ampion In Adults With Respiratory Distress Secondary to COVID-19 Infection

NCT04606784•Ampio Pharmaceuticals. Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, ≥ 18 years old.
•2. 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.
•3. 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
•4. A signed informed consent form from the patient or the patient's legal representative must be available.

Exclusion Criteria

•1. 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.
•2. Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
•3. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
•4. Patient is on chronic immunosuppressive medication.
•5. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
•6. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
•7. Patient has known pregnancy or is currently breastfeeding.
•8. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
•9. Baseline QT prolongation.

Locations (1)

Research Site

Colorado Springs, Colorado, United States

Key Dates

Start Date

October 28, 2020

Primary Completion Date

June 15, 2021

Completion Date

June 15, 2021

Last Updated

March 21, 2022

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

Ampion

BIOLOGICAL

Standard of Care

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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