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

• ClinicalTrials.gov Identifier: NCT04456452
• Recruitment Status: Completed
• First Posted: July 2, 2020
• Last Update Posted: January 13, 2021
• Sponsor: Ampio Pharmaceuticals. Inc.
• Information provided by (Responsible Party): Ampio Pharmaceuticals. Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Biological: Ampion; Other: Standard of Care	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation
• Actual Study Start Date: July 27, 2020
• Actual Primary Completion Date: September 8, 2020
• Actual Study Completion Date: November 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ampion; Ampion	Biological: Ampion; Ampion, administered by intravenous infusion; Other: Standard of Care; Standard of Care
Standard of Care; Standard of Care	Other: Standard of Care; Standard of Care

Outcome Measures

Primary Outcome Measures :

1. Incidence and severity of adverse events [ Time Frame: Primary endpoint at day 5 ]
   Incidence and severity of adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Colorado

Research Site

Colorado Springs, Colorado, United States, 80907

Sponsors and Collaborators

Ampio Pharmaceuticals. Inc.

More Information

• Responsible Party: Ampio Pharmaceuticals. Inc.
• ClinicalTrials.gov Identifier: NCT04456452
• Other Study ID Numbers: AP-016
• First Posted: July 2, 2020
• Last Update Posted: January 13, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No