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)
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ClinicalTrials.gov Identifier: NCT04497987 |
Recruitment Status :
Completed
First Posted : August 4, 2020
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 SARS-CoV2 | Drug: Bamlanivimab Drug: Placebo Drug: Etesevimab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study |
Actual Study Start Date : | August 2, 2020 |
Actual Primary Completion Date : | January 16, 2021 |
Actual Study Completion Date : | May 20, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Bamlanivimab (Part 1)
Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
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Drug: Bamlanivimab
Administered IV.
Other Names:
|
Placebo Comparator: Placebo (Part 1)
Participants received single IV infusion of Placebo.
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Drug: Placebo
Administered IV. |
Experimental: Bamlanivimab (Part 2-Prevention)
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.
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Drug: Bamlanivimab
Administered IV.
Other Names:
|
Experimental: Bamlanivimab + Etesevimab (Part 2-Prevention)
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
Administered IV.
Other Names:
Drug: Etesevimab Administered IV.
Other Names:
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Placebo Comparator: Placebo Comparator: Placebo (Part 2-Prevention)
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
Administered IV. |
Experimental: Bamlanivimab (Part 2 - Treatment)
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
Administered IV.
Other Names:
|
Experimental: Bamlanivimab + Etesevimab (Part 2- Treatment)
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
Administered IV.
Other Names:
Drug: Etesevimab Administered IV.
Other Names:
|
Experimental: Bamlanivimab (Part 3)
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
Administered IV.
Other Names:
|
Experimental: Bamlanivimab + Etesevimab (Part 3)
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: Bamlanivimab
Administered IV.
Other Names:
Drug: Etesevimab Administered IV.
Other Names:
|
- Percentage of Participants With COVID-19 [ Time Frame: 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.
- Percentage of Participants With Moderate or Worse Severity COVID-19 [ Time Frame: 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 [ Time Frame: Week 4 ]Percentage of Participants with SARS-CoV-2.
- Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 8 ]Percentage of Participants Who Die Due to COVID-19.
- Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone [ Time Frame: Day 29, 57, 85, 141 and 169 ]Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497987

Study Director: | 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 |
Documents provided by Eli Lilly and Company:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04497987 |
Other Study ID Numbers: |
18063 J2X-MC-PYAD ( Other Identifier: Eli Lilly and Company ) CoVPN #3501 ( Other Identifier: National Institute of Allergy and Infectious Diseases (NIAID) ) |
First Posted: | August 4, 2020 Key Record Dates |
Results First Posted: | February 4, 2022 |
Last Update Posted: | February 4, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (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. |
URL: | https://vivli.org/ |
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 |
Prevention |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Bamlanivimab Antiviral Agents Anti-Infective Agents |