Brandon, Florida 33511

  • Covid19

Purpose:

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.


Study summary:

This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.


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


NCT ID:

NCT04771351


Primary Contact:

Study Director
Mike Royal, MD
Sorrento Therapeutics

Mike Royal, MD
Phone: (858) 203-4100 ext. 4146
Email: mroyal@sorrentotherapeutics.com


Backup Contact:

N/A


Location Contact:

Brandon, Florida 33511
United States

Daniel Lorch, MD

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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