Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
Completed · Phase 1
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT04456452
- Run by
- Ampio Pharmaceuticals. Inc.
- People needed
- 10
- Starts
- 2020-07-27
- Expected to finish
- 2020-11-30
- Last updated by the study team
- 2021-01-13
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
Where it is running
- Research Site — Colorado Springs, Colorado, United States
Full record on ClinicalTrials.gov
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