Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

Study Overview
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Brief Summary
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This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.

Detailed Description
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This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. Subjects will be followed for approximately 70 days post dosing.

Official Title
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A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

Conditions
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Covid19

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive for COVID-19 by an approved antigen test Mild symptoms consistent with a COVID-19 viral infection Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol Willing to follow contraception guidelines Exclusion Criteria: Evidence of moderate COVID-19 per FDA severity categorization Pregnant or lactating and breast feeding or planning on either during the study Has a documented infection other than COVID-19 Has received a COVID-19 vaccine 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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-AMG<br>A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered | Biological: COVI-AMG<br>* COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)<br>* Other names: STI-2020;|
| Placebo Comparator: Placebo<br>A single injection of placebo will be administered | 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 remained out of the hospital or emergency room through Day 29 | Proportion of subjects who have remained out of the hospital or emergency room through Day 29 | Randomization to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 | Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test | Randomization to Day 8, 15, 29, 43, 70 | 
| Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70 | Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70 | Randomization to Day 43 and Day 70 | 
| Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score | Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43 | Randomization to Day 15, 29, 43 | 
| Time to resolution of fever | For subjects who have a fever at randomization, time to resolution of the fever | Randomization through study completion at Day 70 | 

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