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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04734860

Run by

Sorrento Therapeutics, Inc.

People needed

0

Starts

2021-04-01

Expected to finish

2021-11-01

Last updated by the study team

2022-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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