A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: LY3819253

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • San Diego, California, United States, 92161
      • Veterans Affairs Medical Center San Diego
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
  • New York
    • New York, New York, United States, 10016
      • Alexandria Center for Life - NYC/ NYCEDC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Greenville, North Carolina, United States, 27834
      • Unified Research Enterprise Brody School of Medicine at ECU
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple Univ School of Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3819253; Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.	Drug: LY3819253; Administered IV.; Other Names: LY-CoV555; Bamlanivimab
PLACEBO_COMPARATOR: Placebo; Participants received single dose of Placebo as intravenous infusion.	Drug: Placebo; Administered IV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.	Baseline through Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29	Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.	Day 29
Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load	Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.	Baseline, Day 29
Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC	The SARS-CoV-2 viral load was derived from the cycle time (CT) values using a polymerase chain reaction (PCR) assay. Higher CT values indicate a lower viral load.	Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose
Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance	Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.	Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: AbCellera Biologics Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2020
• Primary Completion (ACTUAL): August 26, 2020
• Study Completion (ACTUAL): August 26, 2020

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Bamlanivimab
• Other Study ID Numbers: 17823; J2W-MC-PYAA (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes