Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)

Completed · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04906694

Run by

Sorrento Therapeutics, Inc.

People needed

97

Starts

2021-11-16

Expected to finish

2022-01-13

Last updated by the study team

2022-02-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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

You may not qualify if…

• In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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