Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

Study Overview
=================
Brief Summary
-----------------
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

Detailed Description
-----------------
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.

Official Title
-----------------
A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

Conditions
-----------------
Covid19

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization No medical or psychiatric conditions that could put the subject at risk Willing to follow contraception guidelines Exclusion Criteria: Clinical signs of COVID-19 indicative of impending hospitalization Documented infection in addition to COVID-19 that requires systemic treatment Medical condition that could adversely impact safety, in the Investigator's opinion Is or planning to be pregnant or lactating 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 received or will receive during study participation a vaccine for COVID-19 Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-AMG<br>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>Placebo will be administered | Drug: Placebo<br>* Diluent solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events by type, frequency, severity, and causality (safety) | Safety as assessed by incidence of adverse events by type, frequency, severity, and causality | Randomization through study completion at Day 70 | 
| Changes in viral shedding from Baseline to Day 15 | Changes in viral shedding from Baseline to Day 15 | Randomization to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in viral shedding from Baseline to Day 8, 29, 43, and 70 | Changes in viral shedding from Baseline to Day 8, 29, 43, and 70 | Randomization to Day 8, 29, 43, 70 | 
| Time to viral RNA negativity | Time to viral RNA negativity using nasopharyngeal reverse transcription PCR | Randomization through study completion at Day 70 | 
| Time to resolution of symptoms | Time to resolution of symptoms as assessed by the COVID-19 PRO instrument | Randomization through study completion at Day 70 | 

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