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

NCT ID: NCT04606784

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2021-06-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ampion

Ampion

Group Type: EXPERIMENTAL

Ampion

Intervention Type: BIOLOGICAL

Ampion, nebulized for inhalation

Standard of Care

Intervention Type: OTHER

Standard of Care

Standard of Care

Standard of Care

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Standard of Care

Interventions

Ampion

Ampion, nebulized for inhalation

Intervention Type: BIOLOGICAL

Standard of Care

Standard of Care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ampio Pharmaceuticals. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Colorado Springs, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34775578 (View on PubMed)

Other Identifiers

AP-014

Identifier Type: -

Identifier Source: org_study_id