Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV
push. Subjects will be followed for 70 days after 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:
- Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less
than 7 days prior to Screening and not requiring imminent hospitalization
- No medical or psychiatric conditions that could put the subject at risk
- Willing to follow contraception guidelines
Exclusion Criteria:
- Clinical signs of COVID-19 indicative of impending hospitalization
- Documented infection in addition to COVID-19 that requires systemic treatment
- Medical condition that could adversely impact safety, in the Investigator's opinion
- Is or planning to be pregnant or lactating
- 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
- Has received or will receive during study participation a vaccine for COVID-19
- Has participated in clinical trial protocols in the last 12 months, unless the
Investigator believes that there may be a direct benefit to the subject
Mike Royal, MD, Study Director
Sorrento Therapeutics