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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Biological: COVI-DROPS
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-DROPS<br>10, 20, or 40 mg of COVI-DROPS administered intranasally | Biological: COVI-DROPS<br>* COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2<br>* Other names: STI-2099;|
| Placebo Comparator: Placebo<br>2 mL administered intranasally | Drug: Placebo<br>* Diluent solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who have COVID-19-related visit or hospitalization | 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) | Baseline through Day 29 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19