Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
NCT ID: NCT04906694
Last Updated: 2022-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2021-11-16
2022-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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COVI-DROPS
10, 20, or 40 mg of COVI-DROPS administered intranasally
COVI-DROPS
COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
Placebo
2 mL administered intranasally
Placebo
Diluent solution
Interventions
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COVI-DROPS
COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
Placebo
Diluent solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 visits and follow-up as required by this protocol
* Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity
* Willing to follow contraception guidelines
Exclusion Criteria
* Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process.
* Has a documented infection other than COVID-19
* Pregnant or lactating women who are breast feeding or planning on either during the study
* Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
* Has a high risk of progressing to severe COVID-19 per CDC's risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html)
* Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.
18 Years
55 Years
ALL
No
Sponsors
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Sorrento Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mike Royal, MD
Role: STUDY_DIRECTOR
Sorrento Therapeutics, Inc.
Locations
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Future Innovative Treatments, LLC
Colorado Springs, Colorado, United States
Clinical Neuroscience dba CNS Healthcare
Jacksonville, Florida, United States
Med-Care Research
Miami, Florida, United States
Clinical Neuroscience Solutions Healthcare
Orlando, Florida, United States
Precision Research Center
Tampa, Florida, United States
Clinical Site Partners, Inc
Winter Park, Florida, United States
Randomize Now
Peachtree City, Georgia, United States
Revival Research Institute
Dearborn, Michigan, United States
Quality Clinical Research
Omaha, Nebraska, United States
Remington Davis
Columbus, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
WR-ClinSearch
Chattanooga, Tennessee, United States
Advanced Medical Trials
Georgetown, Texas, United States
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, United States
Centex Studies Inc. Houston
Houston, Texas, United States
LinQ
Pearland, Texas, United States
Epic Research
Red Oak, Texas, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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DRP-COV-201US
Identifier Type: -
Identifier Source: org_study_id
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