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This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.
Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-DROPS | Experimental | 10, 20, or 40 mg of COVI-DROPS administered intranasally |
|
| Placebo | Placebo Comparator | 2 mL administered intranasally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVI-DROPS | Biological | COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who have COVID-19-related visit or hospitalization | Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29) | Baseline through Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29 | Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29 | Baseline through Day 29 |
| Viral load change from baseline to D8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Royal, MD | Sorrento Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Future Innovative Treatments, LLC | Colorado Springs | Colorado | 80907 | United States | ||
| Clinical Neuroscience dba CNS Healthcare |
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| Placebo | Drug | Diluent solution |
|
Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) |
| Baseline to Day 8 |
| Change in WHO Clinical Progression Scale score | Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome) | Baseline to Day 8 and Day 29 |
| Viral load change from baseline to D29 | Viral load change from baseline to D29, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) | Baseline to Day 29 |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Med-Care Research | Miami | Florida | 33165 | United States |
| Clinical Neuroscience Solutions Healthcare | Orlando | Florida | 32801 | United States |
| Precision Research Center | Tampa | Florida | 33614 | United States |
| Clinical Site Partners, Inc | Winter Park | Florida | 32789 | United States |
| Randomize Now | Peachtree City | Georgia | 30269 | United States |
| Revival Research Institute | Dearborn | Michigan | 48126 | United States |
| Quality Clinical Research | Omaha | Nebraska | 68114 | United States |
| Remington Davis | Columbus | Ohio | 43215 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| WR-ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Advanced Medical Trials | Georgetown | Texas | 78628 | United States |
| Precision Comprehensive Clinical Research Solutions | Grapevine | Texas | 76051 | United States |
| Centex Studies Inc. Houston | Houston | Texas | 77062 | United States |
| LinQ | Pearland | Texas | 77584 | United States |
| Epic Research | Red Oak | Texas | 75154 | United States |
| Infectious Diseases Associates of Central Virginia | Lynchburg | Virginia | 24501 | United States |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| C000714227 | STI-2020 |
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