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

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WITHDRAWN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

2021-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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COVI-AMG 100 mg

A single injection of 100 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)

COVI-AMG 200 mg

A single injection of 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No