A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
NCT ID: NCT04411628
Last Updated: 2021-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2020-05-28
2020-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY3819253
Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.
LY3819253
Administered IV.
Placebo
Participants received single dose of Placebo as intravenous infusion.
Placebo
Administered IV.
Interventions
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LY3819253
Administered IV.
Placebo
Administered IV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are men or non-pregnant women
* Women of childbearing potential must agree to use at least one highly effective form of contraception for the entirety of the study
* Agree to the collection of nasopharyngeal swabs and venous blood
Exclusion Criteria
* Received convalescent COVID-19 plasma treatment prior to enrollment
* Were resident in a nursing home or long-term care facility immediately prior to current hospitalization
* Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product
* Have an oxygen saturation (SpO2) less than (\<)88 percent (%) while breathing room air at rest at randomization.
18 Years
75 Years
ALL
No
Sponsors
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AbCellera Biologics Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Veterans Affairs Medical Center San Diego
San Diego, California, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Alexandria Center for Life - NYC/ NYCEDC
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Unified Research Enterprise Brody School of Medicine at ECU
Greenville, North Carolina, United States
Temple Univ School of Med
Philadelphia, Pennsylvania, United States
Countries
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References
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Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
Other Identifiers
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J2W-MC-PYAA
Identifier Type: OTHER
Identifier Source: secondary_id
17823
Identifier Type: -
Identifier Source: org_study_id