NCT04497987

Brief Summary

The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,180

participants targeted

Target at P50-P75 for phase_3 covid19

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

27 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

First Submitted

Initial submission to the registry

July 31, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

August 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 4, 2022

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

July 31, 2020

Results QC Date

January 11, 2022

Last Update Submit

February 2, 2022

Conditions

COVID-19SARS-CoV2

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With COVID-19

    The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.

    Week 8 after randomization

Secondary Outcomes (6)

  • Percentage of Participants With Moderate or Worse Severity COVID-19

    Week 8 after randomization

  • Percentage of Participants With SARS-CoV-2

    Week 4

  • Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19

    Week 8

  • Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death

    Week 8

  • Percentage of Participants Who Die Due to COVID-19

    Week 8

  • +1 more secondary outcomes

Study Arms (9)

Bamlanivimab (Part 1)

EXPERIMENTAL

Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.

Drug: Bamlanivimab

Placebo (Part 1)

PLACEBO COMPARATOR

Participants received single IV infusion of Placebo.

Drug: Placebo

Bamlanivimab (Part 2-Prevention)

EXPERIMENTAL

Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

Drug: Bamlanivimab

Bamlanivimab + Etesevimab (Part 2-Prevention)

EXPERIMENTAL

Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

Drug: BamlanivimabDrug: Etesevimab

Placebo Comparator: Placebo (Part 2-Prevention)

PLACEBO COMPARATOR

Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

Drug: Placebo

Bamlanivimab (Part 2 - Treatment)

EXPERIMENTAL

Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

Drug: Bamlanivimab

Bamlanivimab + Etesevimab (Part 2- Treatment)

EXPERIMENTAL

Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

Drug: BamlanivimabDrug: Etesevimab

Bamlanivimab (Part 3)

EXPERIMENTAL

Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. \[Participants received single IV infusion of 700 mg bamlanivimab.\]

Drug: Bamlanivimab

Bamlanivimab + Etesevimab (Part 3)

EXPERIMENTAL

Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. \[Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.\]

Drug: BamlanivimabDrug: Etesevimab

Interventions

BamlanivimabDRUG

Administered IV.

Also known as: LY-CoV555, LY3819253
Bamlanivimab (Part 1)Bamlanivimab (Part 2 - Treatment)Bamlanivimab (Part 2-Prevention)Bamlanivimab (Part 3)Bamlanivimab + Etesevimab (Part 2- Treatment)Bamlanivimab + Etesevimab (Part 2-Prevention)Bamlanivimab + Etesevimab (Part 3)
PlaceboDRUG

Administered IV.

Placebo (Part 1)Placebo Comparator: Placebo (Part 2-Prevention)
EtesevimabDRUG

Administered IV.

Also known as: LY-CoV016, LY3832479
Bamlanivimab + Etesevimab (Part 2- Treatment)Bamlanivimab + Etesevimab (Part 2-Prevention)Bamlanivimab + Etesevimab (Part 3)

Eligibility Criteria

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

You may qualify if:

  • Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization
  • Are men or non-pregnant women who agree to contraceptive requirements
  • Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities
  • Have venous access sufficient to allow intravenous infusions and blood sampling
  • The participant or legally authorized representative give signed informed consent
  • Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening
  • Are greater than or equal to (≥) 65 years of age
  • Have a body mass index (BMI) ≥ 35
  • Have chronic kidney disease
  • Have type 1 or type 2 diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment, or
  • Are ≥ 55 years of age AND have
  • cardiovascular disease, OR
  • hypertension, OR
  • +2 more criteria

You may not qualify if:

  • Parts 1 and 2:
  • Recovered from confirmed COVID-19 disease or asymptomatic infection
  • Prior history of a positive SARS-CoV-2 serology test
  • History of convalescent COVID-19 plasma treatment
  • Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine
  • Previous receipt of SAR-CoV-2-specific monoclonal antibodies
  • Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Unv of AL Sch of Med Div of Infectious Diseases

Birmingham, Alabama, 35294, United States

Location

Care Access Research

Phoenix, Arizona, 85023, United States

Location

Allergy and Asthma Clin of NW Ark

Bentonville, Arkansas, 72712, United States

Location

Care Access Research LLC

Huntington Beach, California, 92648, United States

Location

Alta Bates SMC

Oakland, California, 94609, United States

Location

University of Colorado-Anschultz Medical Campus

Aurora, Colorado, 80045, United States

Location

NIAID

Miami, Florida, 33136, United States

Location

NIAID

Decatur, Georgia, 30030, United States

Location

Belmont Village Lincoln Park

Lincoln Park, Illinois, 60614, United States

Location

Family Medicine

Indianapolis, Indiana, 46260, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Care Access Rch Lake Charles

Lake Charles, Louisiana, 70601, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112 2715, United States

Location

NIAID - National Institute of Allergy & Infectious Diseases

Bethesda, Maryland, 20892, United States

Location

Care Access

Boston, Massachusetts, 02110, United States

Location

St. Paul IDA-CARe

Saint Paul, Minnesota, 55101, United States

Location

Care Access

Jackson, Mississippi, 39206, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

Care Access Research - Bronx

The Bronx, New York, 10456, United States

Location

NIAD

Chapel Hill, North Carolina, 27599, United States

Location

Valley Medical Primary Care

Centerville, Ohio, 45459, United States

Location

Univ of Cin College of Med

Cincinnati, Ohio, 45219, United States

Location

OSU Med Intl Med Houston Ctr

Tulsa, Oklahoma, 74127, United States

Location

Donahoe Manor

Bedford, Pennsylvania, 15522, United States

Location

Belmont Village, West Univ

Houston, Texas, 77025, United States

Location

Burke Internal Medicine and Research

Burke, Virginia, 22015, United States

Location

Related Publications (4)

  • 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

  • Cohen MS, Nirula A, Mulligan MJ, Novak RM, Marovich M, Yen C, Stemer A, Mayer SM, Wohl D, Brengle B, Montague BT, Frank I, McCulloh RJ, Fichtenbaum CJ, Lipson B, Gabra N, Ramirez JA, Thai C, Chege W, Gomez Lorenzo MM, Sista N, Farrior J, Clement ME, Brown ER, Custer KL, Van Naarden J, Adams AC, Schade AE, Dabora MC, Knorr J, Price KL, Sabo J, Tuttle JL, Klekotka P, Shen L, Skovronsky DM; BLAZE-2 Investigators. Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):46-55. doi: 10.1001/jama.2021.8828.

    PMID: 34081073DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

bamlanivimabetesevimab

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 4, 2020

Study Start

August 2, 2020

Primary Completion

January 16, 2021

Study Completion

May 20, 2021

Last Updated

February 4, 2022

Results First Posted

February 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

US(27)