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

COVID-19 Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456452
• Other study ID #: AP-016
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Ampio Pharmaceuticals. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 30, 2020
• Est. primary completion date: September 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Ampion
Ampion, administered by intravenous infusion

Other:
• Standard of Care
Standard of Care

Locations

Country	Name	City	State
United States	Research Site	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Ampio Pharmaceuticals. Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events	Incidence and severity of adverse events	Primary endpoint at day 5