A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff

Phase 3

Completed

• Conditions: COVID-19; SARS-CoV2
• Interventions: Drug: Bamlanivimab; Drug: Placebo; Drug: Etesevimab

• Registration Number: NCT04497987
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study Start: 2020-08-02
• Study First Posted: 2020-08-04
• Primary Completion: 2021-01-16
• Study Completion: 2021-05-20
• Results First Submitted: 2022-01-11
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Results First Posted: 2022-02-04
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1180

Inclusion Criteria

• 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
    • chronic obstructive pulmonary disease or other chronic respiratory disease

• Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bamlanivimab + Etesevimab (Part 2- Treatment)	Etesevimab	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.
Bamlanivimab (Part 2 - Treatment)	Bamlanivimab	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.
Bamlanivimab (Part 2-Prevention)	Bamlanivimab	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.
Placebo (Part 1)	Placebo	Participants received single IV infusion of Placebo.
Placebo Comparator: Placebo (Part 2-Prevention)	Placebo	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.
Bamlanivimab + Etesevimab (Part 2- Treatment)	Bamlanivimab	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.
Bamlanivimab + Etesevimab (Part 2-Prevention)	Bamlanivimab	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.
Bamlanivimab (Part 1)	Bamlanivimab	Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
Bamlanivimab + Etesevimab (Part 2-Prevention)	Etesevimab	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.
Bamlanivimab (Part 3)	Bamlanivimab	Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. \[Participants received single IV infusion of 700 mg bamlanivimab.\]
Bamlanivimab + Etesevimab (Part 3)	Bamlanivimab	Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. \[Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.\]
Bamlanivimab + Etesevimab (Part 3)	Etesevimab	Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. \[Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.\]

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With COVID-19	Week 8 after randomization	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Moderate or Worse Severity COVID-19	Week 8 after randomization	The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. 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.
Percentage of Participants With SARS-CoV-2	Week 4	Percentage of Participants with SARS-CoV-2.
Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19	Week 8	Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death	Week 8	Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Percentage of Participants Who Die Due to COVID-19	Week 8	Percentage of Participants Who Die Due to COVID-19.
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone	Day 29, 57, 85, 141 and 169	Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.

Trial Locations

Locations (25)

Care Access; 🇺🇸 Jackson, Mississippi, United States

Care Access Research LLC; 🇺🇸 Huntington Beach, California, United States

Valley Medical Primary Care; 🇺🇸 Centerville, Ohio, United States

Alta Bates SMC; 🇺🇸 Oakland, California, United States

Donahoe Manor; 🇺🇸 Bedford, Pennsylvania, United States

Burke Internal Medicine and Research; 🇺🇸 Burke, Virginia, United States

Care Access Research - Bronx; 🇺🇸 Bronx, New York, United States

OSU Med Intl Med Houston Ctr; 🇺🇸 Tulsa, Oklahoma, United States

St. Paul IDA-CARe; 🇺🇸 Saint Paul, Minnesota, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Unv of AL Sch of Med Div of Infectious Diseases; 🇺🇸 Birmingham, Alabama, United States

Family Medicine; 🇺🇸 Indianapolis, Indiana, United States

Children's Hospital & Medical Center; 🇺🇸 Omaha, Nebraska, United States

Univ of Cin College of Med; 🇺🇸 Cincinnati, Ohio, United States

University of Colorado-Anschultz Medical Campus; 🇺🇸 Aurora, Colorado, United States

NIAID - National Institute of Allergy & Infectious Diseases; 🇺🇸 Bethesda, Maryland, United States

Care Access Research; 🇺🇸 Phoenix, Arizona, United States

Allergy and Asthma Clin of NW Ark; 🇺🇸 Bentonville, Arkansas, United States

NIAID; 🇺🇸 Decatur, Georgia, United States

Care Access Rch Lake Charles; 🇺🇸 Lake Charles, Louisiana, United States

Belmont Village Lincoln Park; 🇺🇸 Lincoln Park, Illinois, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Belmont Village, West Univ; 🇺🇸 Houston, Texas, United States

NIAD; 🇺🇸 Chapel Hill, North Carolina, United States