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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID: NCT04771351
Run by: Sorrento Therapeutics, Inc.
People needed: 0
Starts: 2021-04-01
Expected to finish: 2021-10-01
Last updated by the study team: 2022-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Teradan Clinical Trials — Brandon, Florida, United States

Full record on ClinicalTrials.gov

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