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A different study will be conducted.
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This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-AMG 100 mg | Experimental | A single injection of 100 mg of COVI-AMG will be administered. |
|
| COVI-AMG 200 mg | Experimental | A single injection of 200 mg of COVI-AMG will be administered. |
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| Placebo | Placebo Comparator | A single injection of placebo will be administered. |
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| 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 |
|---|---|---|
| Proportion of subjects who are alive and free of respiratory failure at Day 29 | Proportion of subjects who are alive and free of respiratory failure at Day 29 | Baseline through Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load reduction | Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test | Baseline to Day 4, 15, and 29 |
| Time to sustained clinical improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Royal, MD | Sorrento Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teradan Clinical Trials | Brandon | Florida | 33511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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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 sustained clinical improvement defined as achieving a score of ≤2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29
| Baseline through Day 29 |
| Proportion of subjects with clinical improvement | Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29 | Baseline to Day 15 and 29 |
| All-cause mortality at Day 29 | All-cause mortality at Day 29 | Baseline through Day 29 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |