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

Sorrento Therapeutics, Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Covid19

Interventions

COVI-AMGBIOLOGICAL

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

PlaceboDRUG

Diluent solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Teradan Clinical Trials

Brandon, Florida, United States

Outcomes

Primary Outcomes

Proportion of subjects who are alive and free of respiratory failure at Day 29

Time frame: Baseline through Day 29

Secondary Outcomes

Viral load reduction

Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test

Time frame: 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

Time frame: 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

Time frame: Baseline to Day 15 and 29

All-cause mortality at Day 29

Time frame: Baseline through Day 29

Data from ClinicalTrials.gov

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