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COVI

Phase 2

Covid19 | Biologics | Infectious Disease |Sorrento Therapeutics, Inc.|Trials Updated: Feb 3, 2022

COVI target and mechanism

ModalityBiologics

Also known as COVI-DROPS

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

COVI clinical trials

COVI · 1 trial · 1 indication

Phase 2 1
NCT04906694Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)Covid19
COMPLETED97 Analytics
PHASE2COMPLETED
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
Covid19
NCT0490669497
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Study Endpoints

Primary Endpoints

Proportion of subjects who have COVID-19-related visit or hospitalization
Baseline through Day 29

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)

Secondary Endpoints

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
Baseline to Day 8
Change in WHO Clinical Progression Scale score
Baseline to Day 8 and Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
COVI-DROPSEXPERIMENTAL10, 20, or 40 mg of COVI-DROPS administered intranasally
PlaceboPLACEBO_COMPARATOR2 mL administered intranasally

Interventions

NameTypeDescription
COVI-DROPSBIOLOGICALCOVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
PlaceboDRUGDiluent solution
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment * Either have no COVID-19 symptoms (asymptomatic) or mild symptoms * Must be willing and able to comply with all planned study procedures and be available for all study visi...

Countries:United States
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