Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation

NCT ID: NCT04456452

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2020-11-30

Brief Summary

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.

Conditions

COVID-19

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, administered by intravenous infusion

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, administered by intravenous infusion

Intervention Type: BIOLOGICAL

Standard of Care

Standard of Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or female, 18 years to 89 years old (inclusive).

2. Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2.

3. Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).

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, irrespective of the provision of treatments.

2. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).

3. Patient is on chronic immunosuppressive medication.

4. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.

5. 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).

6. Patient has known pregnancy or is currently breastfeeding.

7. Participation in another clinical trial.

8. Baseline QT prolongation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 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

Other Identifiers

AP-016

Identifier Type: -

Identifier Source: org_study_id