Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.

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

Details

• Lead Sponsor: Sorrento Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Positive for COVID-19 by an approved antigen test

• Progressive disease suggestive of ongoing COVID-19 infection

• Requires hospitalization for acute medical care

• Provides written informed consent

• Willing to follow contraception guidelines during study

Exclusion Criteria:

• Requires high-flow oxygen supplementation

• Current or imminent respiratory failure

• Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours

• Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments

• Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)

• Pregnant or lactating and breast feeding, or planning on either during the study

• Unable to comply with planned study procedures and be available for all follow-up visits