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

Ampio Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Biological: Ampion; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04456452

AP-016

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Ampion

Experimental group

Description:

Ampion

Treatment:

Biological: Ampion

Other: Standard of Care

Standard of Care

Other group

Description:

Standard of Care

Treatment:

Other: Standard of Care