Status:
WITHDRAWN
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.
Detailed Description
This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild CO...
Eligibility Criteria
Inclusion
- Positive for COVID-19 by an approved antigen test
- Mild symptoms consistent with a COVID-19 viral infection
- Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol
- Willing to follow contraception guidelines
Exclusion
- Evidence of moderate COVID-19 per FDA severity categorization
- Pregnant or lactating and breast feeding or planning on either during the study
- Has a documented infection other than COVID-19
- Has received a COVID-19 vaccine
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04734860
Start Date
April 1 2021
End Date
November 1 2021
Last Update
February 25 2022
Active Locations (4)
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1
Collaborative NeuroScience Research, LLC
Garden Grove, California, United States, 92845
2
Synergy Healthcare LLC
Bradenton, Florida, United States, 34208
3
Med-Care Research
Miami, Florida, United States, 33165
4
ETNA Medical Center
Tamarac, Florida, United States, 33321