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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ampion | Experimental | Ampion |
|
| Standard of Care | Other | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampion | Biological | Ampion, administered by intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Incidence and severity of adverse events | Primary endpoint at day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Colorado Springs | Colorado | 80907 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2022 | |
| Reset | Jul 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2022 | Jul 18, 2023 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C526103 | aspartyl-alanyl-diketopiperazine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care |
| Other |
Standard of Care |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |