Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19

Study Overview
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Brief Summary
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This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.

Detailed Description
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This is a multi-center, randomized, double-blind, placebo-controlled study followed by an expansion cohort phase designed to investigate the safety, PK profile, and efficacy of a single injection of COVI-AMG in outpatient subjects with COVID-19 but are not likely to require hospital admission within 24 hours. Subjects will receive one of the following treatments: 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo. Subjects will be followed for 60 days after 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 Outpatients With COVID-19 Who Are Asymptomatic or Have Mild 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: Must be COVID-19 positive by RT-PCR or an equivalent test, using an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or salivary) ≤ 72 hours prior to randomization. A historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented. Must be asymptomatic OR have mild symptoms but not requiring imminent (within 24h) hospitalization. Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol. Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. Exclusion Criteria: Have a documented infection other than COVID-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study. Have any medical condition that, in the Investigator's opinion, could adversely impact safety. Be pregnant or lactating and breast feeding 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. Note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.

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: Sequential Assignment
Interventional Model Description: Initially, 2 subjects will be enrolled at the 40 mg dose level. If no safety concerns arise, 48 subjects will then be randomized 1:1:1:1 to receive 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo.
Masking: Quadruple


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 given on Study Day 1. Standard of care will be maintained for all subjects throughout the study. | 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 given on Study Day 1. Standard of care will be maintained for all subjects throughout the study. | Drug: Placebo<br>* Diluent solution<br>|

What is the study measuring?
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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 60 | 
| Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety) | Safety as assessed by incidence of treatment-emergent adverse events by type, frequency, severity, and causality | Randomization through study completion at Day 60 | 
| Incidence of serious adverse events by type, frequency, severity, and causality (safety) | Safety as assessed by incidence of serious adverse events by type, frequency, severity, and causality | Randomization through study completion at Day 60 | 
| Incidence of dose-limiting toxicities (safety) | Safety as assessed by incidence of dose-limiting toxicities | Randomization through study completion at Day 60 | 
| Incidence of clinically meaningful laboratory abnormalities (safety) | Safety as assessed by incidence of clinically meaningful laboratory abnormalities | Randomization through study completion at Day 60 | 
| Viral load as assessed using plasma and salivary samples at various timepoints | Viral load as assessed using plasma and salivary samples at various timepoints correlated with nasopharyngeal testing | Randomization through study completion at Day 60 | 
| Time from onset of COVID-19 symptoms to treatment (Day 1) | Time from onset of COVID-19 symptoms to treatment (Day 1) | Day 1 | 
| Presence and levels of anti-drug antibodies directed to COVI-AMG | Presence and levels of anti-drug antibodies directed to COVI-AMG | Randomization through study completion at Day 60 | 
| Cytokine levels post-treatment | Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA | Randomization through study completion at Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of COVI-AMG (PK) | Area under the serum concentration-time curve (AUC) of COVI-AMG | Randomization through study completion at Day 60 | 
| Cmax of COVI-AMG (PK) | Maximum observed serum concentration (Cmax) of COVI-AMG | Randomization through study completion at Day 60 | 
| Tmax of COVI-AMG (PK) | Time to Cmax (Tmax) of COVI-AMG | Randomization through study completion at Day 60 | 
| t½ of COVI-AMG (PK) | Apparent serum terminal elimination half life (t½) of COVI-AMG | Randomization through study completion at Day 60 | 

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