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

NCT04456452 | Completed Phase 1 FDA Drug

• 1 other identifier: AP-016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Incidence and severity of adverse events

  Primary endpoint at day 5

Study Arms (2)

Ampion

EXPERIMENTAL

Ampion

Biological: Ampion; Other: Standard of Care

Standard of Care

OTHER

Standard of Care

Other: Standard of Care

Interventions

Ampion BIOLOGICAL

Ampion, administered by intravenous infusion

Ampion

Standard of Care OTHER

Standard of Care

Ampion; Standard of Care

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years to 89 years old (inclusive).
• Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2.
• Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) \<88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).
• A signed informed consent form from the patient or the patient's legal representative must be available.

You may not qualify if:

• In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments.
• Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
• Patient is on chronic immunosuppressive medication.
• As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
• Patient has known pregnancy or is currently breastfeeding.
• Participation in another clinical trial.
• Baseline QT prolongation.

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Research Site

Colorado Springs, Colorado, 80907, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

aspartyl-alanyl-diketopiperazine; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 2, 2020
• Study Start: July 27, 2020
• Primary Completion: September 8, 2020
• Study Completion: November 30, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

US (1)