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A different study will be conducted.
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This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.
This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. Subjects will be followed for approximately 70 days post dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-AMG | Experimental | A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered |
|
| Placebo | Placebo Comparator | A single injection of 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 |
|---|---|---|
| Proportion of subjects who have remained out of the hospital or emergency room through Day 29 | Proportion of subjects who have remained out of the hospital or emergency room through Day 29 | Randomization to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 | Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test | Randomization to Day 8, 15, 29, 43, 70 |
| Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70 |
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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 |
|---|---|---|---|---|---|---|
| Collaborative NeuroScience Research, LLC | Garden Grove | California | 92845 | United States | ||
| Synergy Healthcare LLC |
| 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 |
|
Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70 |
| Randomization to Day 43 and Day 70 |
| Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score | Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43 | Randomization to Day 15, 29, 43 |
| Time to resolution of fever | For subjects who have a fever at randomization, time to resolution of the fever | Randomization through study completion at Day 70 |
| Bradenton |
| Florida |
| 34208 |
| United States |
| Med-Care Research | Miami | Florida | 33165 | United States |
| ETNA Medical Center | Tamarac | Florida | 33321 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |