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

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.

Detailed Description
-----------------
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.

Official Title
-----------------
A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive for COVID-19 by an approved antigen test Progressive disease suggestive of ongoing COVID-19 infection Requires hospitalization for acute medical care Provides written informed consent Willing to follow contraception guidelines during study Exclusion Criteria: Requires high-flow oxygen supplementation Current or imminent respiratory failure Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) Pregnant or lactating and breast feeding, or planning on either during the study Unable to comply with planned study procedures and be available for all follow-up visits

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-AMG 100 mg<br>A single injection of 100 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;|
| Experimental: COVI-AMG 200 mg<br>A single injection of 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who are alive and free of respiratory failure at Day 29 | Proportion of subjects who are alive and free of respiratory failure at Day 29 | Baseline through Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load reduction | Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test | Baseline to Day 4, 15, and 29 | 
| Time to sustained clinical improvement | Time to sustained clinical improvement defined as achieving a score of ≤2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29 | Baseline through Day 29 | 
| Proportion of subjects with clinical improvement | Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29 | Baseline to Day 15 and 29 | 
| All-cause mortality at Day 29 | All-cause mortality at Day 29 | Baseline through Day 29 | 

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