Status:
WITHDRAWN
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04771351
Start Date
April 1 2021
End Date
October 1 2021
Last Update
August 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Teradan Clinical Trials
Brandon, Florida, United States, 33511