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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Biological: Ampion; Other: Standard of Care

• Registration Number: NCT04456452
• Lead Sponsor: Ampio Pharmaceuticals. Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-02
• Study Start: 2020-07-27
• Primary Completion: 2020-09-08
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ampion	Standard of Care	Ampion
Ampion	Ampion	Ampion
Standard of Care	Standard of Care	Standard of Care

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	Primary endpoint at day 5	Incidence and severity of adverse events

Trial Locations

Locations (1)

Research Site; 🇺🇸 Colorado Springs, Colorado, United States