Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress

Ampio Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Covid19

Treatments: Other: Standard of Care; Biological: Ampion

Study type: Interventional

Funder types: Industry

Identifiers

NCT04606784

AP-014

Details and patient eligibility

About

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, ≥ 18 years old.

2. Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.

3. Respiratory distress as evidenced by at least two of the following:

   • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
   • Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90%
   • Requiring supplemental oxygen
   • Diagnosis of mild, moderate, or severe ARDS by Berlin definition

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 within the next 24 hours, irrespective of the provision of treatments.
2. Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
3. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
4. Patient is on chronic immunosuppressive medication.
5. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
6. 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).
7. Patient has known pregnancy or is currently breastfeeding.
8. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
9. Baseline QT prolongation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 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