NCT04411628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started May 2020

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 9, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

May 29, 2020

Results QC Date

November 1, 2021

Last Update Submit

November 10, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29

    Day 29

  • Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load

    Baseline, Day 29

  • Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC

    Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

  • Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance

    Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

Study Arms (2)

LY3819253

EXPERIMENTAL

Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.

Drug: LY3819253

Placebo

PLACEBO COMPARATOR

Participants received single dose of Placebo as intravenous infusion.

Drug: Placebo

Interventions

LY3819253DRUG

Administered IV.

Also known as: LY-CoV555, Bamlanivimab
LY3819253
PlaceboDRUG

Administered IV.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Veterans Affairs Medical Center San Diego

San Diego, California, 92161, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Alexandria Center for Life - NYC/ NYCEDC

New York, New York, 10016, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Unified Research Enterprise Brody School of Medicine at ECU

Greenville, North Carolina, 27834, United States

Location

Temple Univ School of Med

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (3)

  • 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.

    PMID: 35713300DERIVED

  • 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.

    PMID: 34473343DERIVED

  • 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.

    PMID: 34374951DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

bamlanivimab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 2, 2020

Study Start

May 28, 2020

Primary Completion

August 26, 2020

Study Completion

August 26, 2020

Last Updated

November 12, 2021

Results First Posted

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(11)