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

Sorrento Therapeutics, Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

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 * 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

Locations (4)

Collaborative NeuroScience Research, LLC

Garden Grove, California, United States

Synergy Healthcare LLC

Bradenton, Florida, United States

Med-Care Research

Miami, Florida, United States

ETNA Medical Center

Tamarac, Florida, United States

Outcomes

Primary Outcomes

Proportion of subjects who have remained out of the hospital or emergency room through Day 29

Time frame: Randomization to Day 29

Secondary Outcomes

Viral load reduction from baseline to Day 8, 15, 29, 43, and 70

Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test

Time frame: Randomization to Day 8, 15, 29, 43, 70

Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70

Time frame: Randomization to Day 43 and Day 70

Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score

Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43

Time frame: Randomization to Day 15, 29, 43

Time to resolution of fever

For subjects who have a fever at randomization, time to resolution of the fever

Time frame: Randomization through study completion at Day 70

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.