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.
Biological: COVI-AMG
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
Other Name: STI-2020
Drug: Placebo
Diluent solution
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
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
Mike Royal, MD, Study Director
Sorrento Therapeutics