Overview
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
Status:
Recruiting
Recruiting
Trial end date:
2021-11-01
2021-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sorrento Therapeutics, Inc.
Criteria
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