Clinical trial NCT04411628: A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
Official title: A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: AbCellera Biologics Inc.
First posted: 2020-06-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.


Eligibility criteria: Inclusion Criteria:

* Are hospitalized or in the process of being admitted to hospital and have an initial laboratory determination of current COVID-19 infection less than or equal to (≤)72 hours prior to randomization
* 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:

* Require mechanical ventilation or anticipated impending need for mechanical ventilation
* 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.

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 60
Secondary outcomes:
measure: Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29
timeFrame: Day 29
measure: Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load
timeFrame: Baseline, Day 29
measure: Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC
timeFrame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose
measure: Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance
timeFrame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Veterans Affairs Medical Center San Diego
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: New York
country: United States
facility: Alexandria Center for Life - NYC/ NYCEDC
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greenville
country: United States
facility: Unified Research Enterprise Brody School of Medicine at ECU
state: North Carolina
city: Philadelphia
country: United States
facility: Temple Univ School of Med
state: Pennsylvania
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.
citation: 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.
citation: 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.