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

Sorrento Therapeutics

Status and phase

Withdrawn

Phase 2

Conditions

Covid19

Treatments

Drug: Placebo

Biological: COVI-AMG

Study type

Interventional

Funder types

Industry

Identifiers

NCT04734860

AMG-COV-201

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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