Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms.

Detailed Description
-----------------
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. This is a single dose study and three different dose concentrations will be compared to placebo.

Official Title
-----------------
A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: STI-9199
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otherwise healthy, positive for COVID-19 by an EUA-approved rapid antigen or PCR test, has ongoing mild to moderate illness or symptoms with symptom onset starting < 5 days prior to screening visits Must provide written informed consent/assent if a minor which includes signing the institutional review board/independent ethics committee approved consent form prior to participating in any study related activity Willing and able to comply with study procedures and follow-up visits Willing to follow all contraception guidelines Exclusion Criteria: In the Investigator's opinion, has progressive symptoms with likely imminent (24-48 hours) hospitalization or severe COVID-19 illness/symptoms Any medical condition that, in the Investigator's or designee's opinion, could adversely impact participant safety or key objectives of the study Has a prior history of long COVID Has a clinically documents acute infection other than COVID-19 Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding Has participated, or is participating in a clinical reserach study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or IV immunoglobulin within 2 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STI-9199<br>4 mg, 10 mg or 20 mg STI-9199 administered intranasally | Drug: STI-9199<br>* STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2<br>|
| Placebo Comparator: Placebo<br>Placebo administered intranasally | Drug: Placebo<br>* Diluent solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load | Change in viral load from baseline to Day 8 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection | Baseline through Day 8 | 
| Incidence of adverse events (AEs) (safety) | Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials | Baseline through study completion at up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load | Change in viral load from baseline to Day 4, Day 11 and Day 15 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection | Baseline through Day 11 | 
| Participant perceived disease progression | Participants rate their progression of disease on Day 8 and Day 15 when asked Have your COVID symptoms gotten worse since treatment? Yes or No response | Baseline through Day 15 | 
| Rate of COVID-19-related medical visits | Determine the proportion of participants having COVID-19-related medically attended visits, emergency department assessments, hospitalization or all-cause mortality | Baseline through Day 30 | 
| Patient rated response | Proportion of participants scoring ≥ +1 and those scoring ≤ -1 using a patient global impression of change (PGIC) 7-point categorical scale on Day 8 and Day 15 when responding to the question In terms of your COVID-19 symptoms, how much benefit if any did you receive from the treatment? The 7-point scale range is -3 to +3 where -3 is very much worse to +3 very much improved based on how the participant feels post-treatment | Baseline through D15 | 

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