Status:
COMPLETED
Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
Lead Sponsor:
Ampio Pharmaceuticals. Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18-89 years
Phase:
PHASE1
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 req...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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).
- Patient has known pregnancy or is currently breastfeeding.
- Participation in another clinical trial.
- Baseline QT prolongation.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04456452
Start Date
July 27 2020
End Date
November 30 2020
Last Update
January 13 2021
Active Locations (1)
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1
Research Site
Colorado Springs, Colorado, United States, 80907