Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
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ClinicalTrials.gov Identifier: NCT04456452 |
Recruitment Status :
Completed
First Posted : July 2, 2020
Last Update Posted : January 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Biological: Ampion Other: Standard of Care | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation |
Actual Study Start Date : | July 27, 2020 |
Actual Primary Completion Date : | September 8, 2020 |
Actual Study Completion Date : | November 30, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Ampion
Ampion
|
Biological: Ampion
Ampion, administered by intravenous infusion Other: Standard of Care Standard of Care |
Standard of Care
Standard of Care
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Other: Standard of Care
Standard of Care |
- Incidence and severity of adverse events [ Time Frame: Primary endpoint at day 5 ]Incidence and severity of adverse events

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Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456452
United States, Colorado | |
Research Site | |
Colorado Springs, Colorado, United States, 80907 |
Responsible Party: | Ampio Pharmaceuticals. Inc. |
ClinicalTrials.gov Identifier: | NCT04456452 |
Other Study ID Numbers: |
AP-016 |
First Posted: | July 2, 2020 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |