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

A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19

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.

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.