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

Sorrento Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Covid19

Treatments: Drug: Placebo; Biological: COVI-AMG

Study type: Interventional

Funder types: Industry

Identifiers

NCT04771351

AMG-COV-202

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

COVI-AMG 100 mg

Experimental group

Description:

A single injection of 100 mg of COVI-AMG will be administered.

Treatment:

Biological: COVI-AMG

COVI-AMG 200 mg

Experimental group

Description:

A single injection of 200 mg of COVI-AMG will be administered.

Treatment:

Biological: COVI-AMG

Placebo

Placebo Comparator group

Description:

A single injection of placebo will be administered.

Treatment:

Drug: Placebo