Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

Sorrento Therapeutics

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Covid19

Treatments

Biological: COVI-AMG

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

AMG-COV-201-BR

Details and patient eligibility

About

Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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