Status:
WITHDRAWN
Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Detailed Description
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.
Eligibility Criteria
Inclusion
- Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
- No medical or psychiatric conditions that could put the subject at risk
- Willing to follow contraception guidelines
Exclusion
- Clinical signs of COVID-19 indicative of impending hospitalization
- Documented infection in addition to COVID-19 that requires systemic treatment
- Medical condition that could adversely impact safety, in the Investigator's opinion
- Is or planning to be pregnant or lactating
- 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
- Has received or will receive during study participation a vaccine for COVID-19
- Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
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
NCT04738175
Start Date
April 1 2021
End Date
November 1 2021
Last Update
February 25 2022
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