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

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 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). Subjects will be followed to Day 60.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of 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 locally approved RT-PCR within 7 days of planned treatment. Either have no COVID-19 symptoms (asymptomatic) or mild illness/symptoms Must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol Subject must have provided written informed consent Willing to follow contraception guidelines Exclusion Criteria: Moderate or severe illness/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 subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process Documented acute infection other thand COVID-19 Pregnant or lactating women who are breast feeding or planning to during the study Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, 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

Ages Eligible for Study
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Minimum Age: 18 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 mg or 20 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>1 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 |
| --- | --- | --- |
| Viral load change from baseline to D8 | Viral load change from baseline to D8, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) from nasopharyngeal swabs | Baseline to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29 | The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29 | Baseline through Day 29 | 
| 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 | 
| Change in WHO Clinical Progression Scale score | Change in WHO Clinical Progression Scale score at D8 and D29 (score of 0-10, with lower score meaning better outcome) | Baseline to Day 8 and Day 29 | 
| Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29 | Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29 (score of 0-10, with lower score meaning better outcome) | Baseline through Day 29 | 
| Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs | Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs | Baseline to Day 29 | 
| Change in patient-reported COVID-19 symptoms | Change in patient-reported COVID-19 symptoms as assessed using the Patient Reported Outcome Instrument for Capture of COVID-19-Related Symptoms (score of 0-50, with lower score meaning better outcome) | Baseline to Day 8 and Day 29 | 

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