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

• Status: Not yet recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorrento Therapeutics, Inc.

Criteria

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