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A different study will be conducted.
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Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-AMG | Experimental | 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered |
|
| Placebo | Placebo Comparator | Placebo will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVI-AMG | Biological | COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events by type, frequency, severity, and causality (safety) | Safety as assessed by incidence of adverse events by type, frequency, severity, and causality | Randomization through study completion at Day 70 |
| Changes in viral shedding from Baseline to Day 15 | Changes in viral shedding from Baseline to Day 15 | Randomization to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in viral shedding from Baseline to Day 8, 29, 43, and 70 | Changes in viral shedding from Baseline to Day 8, 29, 43, and 70 | Randomization to Day 8, 29, 43, 70 |
| Time to viral RNA negativity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Royal, MD | Sorrento Therapeutics | Study Director |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000714227 | STI-2020 |
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| Placebo | Drug | Diluent solution |
|
Time to viral RNA negativity using nasopharyngeal reverse transcription PCR
| Randomization through study completion at Day 70 |
| Time to resolution of symptoms | Time to resolution of symptoms as assessed by the COVID-19 PRO instrument | Randomization through study completion at Day 70 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |