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 (BLAZE-2)

Lilly

Status and phase: Completed; Phase 3

Conditions: COVID-19; SARS-CoV2

Treatments: Drug: Placebo; Drug: Etesevimab; Drug: Bamlanivimab

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04497987

CoVPN #3501 (Other Identifier)

J2X-MC-PYAD (Other Identifier)

18063

Details and patient eligibility

About

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.

Enrollment: 1,180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,180 participants in 9 patient groups, including a placebo group

Bamlanivimab (Part 1)

Experimental group

Description:

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

Treatment:

Drug: Bamlanivimab

Placebo (Part 1)

Placebo Comparator group

Description:

Participants received single IV infusion of Placebo.

Treatment:

Drug: Placebo

Bamlanivimab (Part 2-Prevention)

Experimental group

Description:

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.

Treatment:

Drug: Bamlanivimab

Bamlanivimab + Etesevimab (Part 2-Prevention)

Experimental group

Description:

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.

Treatment:

Drug: Bamlanivimab

Drug: Etesevimab

Placebo Comparator: Placebo (Part 2-Prevention)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Bamlanivimab (Part 2 - Treatment)

Experimental group

Description:

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.

Treatment:

Drug: Bamlanivimab

Bamlanivimab + Etesevimab (Part 2- Treatment)

Experimental group

Description:

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.

Treatment:

Drug: Bamlanivimab

Drug: Etesevimab

Bamlanivimab (Part 3)

Experimental group

Description:

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

Treatment:

Drug: Bamlanivimab

Bamlanivimab + Etesevimab (Part 3)

Experimental group

Description:

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

Treatment:

Drug: Bamlanivimab

Drug: Etesevimab