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| Name | Class |
|---|---|
| IQVIA Biotech | INDUSTRY |
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The primary aim of the study is to evaluate the safety and tolerability of open-label ST266 given to subjects with confirmed COVID-19 infection through IV administration once a day of 5 consecutive days.
This clinical trial will utilize a 3+3 enrollment design with sentinel approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 0.1 ml/kg IV ST266 once a day for 5 days |
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| Cohort 2 | Experimental | 0.25 ml/kg IV ST266 once a day for 5 days |
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| Cohort 3 | Experimental | 0.5 ml/kg IV ST266 once a day for 5 days |
|
| Cohort 4 | Experimental | 1.0 ml/kg IV ST266 once a day for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST266 | Biological | 1X ST266 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment-Emergent Adverse Events | Determine the incidence and severity of treatment-emergent adverse events related to the IV administration of ST266 based on findings from physical examinations, laboratory evaluations, vital signs, and ECG measurements. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Oximetry | Percent improvement in pulse oximetry from Baseline to Day 14 | 14 days |
| Fever | Time to resolution of fever | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| TNFα at Day 6 | Change in TNFα from Baseline through Day 6 | 6 days |
| IL- 1β at Day 6 | Change in IL- 1β from Baseline through Day 6 | 6 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Steed, MD | Noveome Biotherapeutics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovative Research of West Florida | Clearwater | Florida | 33756 | United States | ||
| Great Lakes Clinical Trials |
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| ID | Term |
|---|---|
| D000080424 | Cytokine Release Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Clinical Status on Ordinal Scale | Improvement or absence of worsening in clinical status on WHO 7-point ordinal scale from baseline to Day 14 | 14 days |
| IL-6 at Day 6 | Change in IL-6 from Baseline through Day 6 | 6 days |
| TNFα at Day 14 | Change in TNFα from Baseline through Day 14 | 14 days |
| IL- 1β at Day 14 | Change in IL- 1β from Baseline through Day 14 | 14 days |
| IL-6 at Day 14 | Change in IL-6 from Baseline through Day 14 | 14 days |
| Chicago |
| Illinois |
| 60640 |
| United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| D012769 | Shock |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |