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

WITHDRAWNPHASE2

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

A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

NCT04734860•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

April 1, 2021

Primary Completion Date

September 1, 2021

Completion Date

November 1, 2021

Last Updated

February 25, 2022

Conditions

Covid19

Interventions

COVI-AMG

BIOLOGICAL

Placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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