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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-11-30

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.

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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COVI-AMG

A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered

Group Type EXPERIMENTAL

COVI-AMG

Intervention Type BIOLOGICAL

COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)

Placebo

A single injection of placebo will be administered

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Diluent solution

Interventions

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COVI-AMG

COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)

Intervention Type BIOLOGICAL

Placebo

Diluent solution

Intervention Type DRUG

Other Intervention Names

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STI-2020

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No