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

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.

• COVI-DROPS (Biological), also known as STI-2099: COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
• Placebo (Drug): Diluent solution

Primary outcomes

• 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 outcomes

• Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29 [Baseline through Day 29]: Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
• Viral load change from baseline to D8 [Baseline to Day 8]: Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)
• Change in WHO Clinical Progression Scale score [Baseline to Day 8 and Day 29]: Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
• Viral load change from baseline to D29 [Baseline to Day 29]: 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)

Sex: All, ages: 18 Years to 55 Years

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 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:

* 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.

• Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.