Trial record 1 of 1 for:
NCT04497987
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 |
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Recruitment Status :
Recruiting
First Posted : August 4, 2020
Last Update Posted : January 22, 2021
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Sponsor:
Eli Lilly and Company
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 SARS-CoV2 | Drug: LY3819253 Drug: Placebo Drug: LY3832479 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 5000 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 |
| Estimated Primary Completion Date : | March 8, 2021 |
| Estimated Study Completion Date : | June 29, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: LY3819253 (Part 1)
LY3819253 administered intravenously (IV).
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Drug: LY3819253
Administered IV.
Other Names:
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Placebo Comparator: Placebo (Part 1)
Placebo administered IV.
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Drug: Placebo
Administered IV. |
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Experimental: LY3819253 (Part 2 - Prevention)
LY3819253 administered IV to prevention cohort.
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Drug: LY3819253
Administered IV.
Other Names:
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Experimental: LY3819253 + LY3832479 (Part 2 - Prevention)
LY3819253 + LY3832479 administered IV to prevention cohort.
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Drug: LY3819253
Administered IV.
Other Names:
Drug: LY3832479 Administered IV.
Other Names:
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Placebo Comparator: Placebo (Part 2 - Prevention)
Placebo administered IV to prevention cohort.
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Drug: Placebo
Administered IV. |
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Experimental: LY3819253 (Part 2 - Treatment)
LY3819253 administered IV to treatment cohort.
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Drug: LY3819253
Administered IV.
Other Names:
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Experimental: LY3819253 + LY3832479 (Part 2 - Treatment)
LY3819253 + LY3832479 administered IV to treatment cohort.
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Drug: LY3819253
Administered IV.
Other Names:
Drug: LY3832479 Administered IV.
Other Names:
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Experimental: LY3819253 (Part 3 - Treatment)
LY3819253 administered IV.
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Drug: LY3819253
Administered IV.
Other Names:
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Experimental: LY3819253 + LY3832479 (Part 3 - Treatment)
LY3819253 + LY3832479 administered IV.
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Drug: LY3819253
Administered IV.
Other Names:
Drug: LY3832479 Administered IV.
Other Names:
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Primary Outcome Measures :
- Percentage of Participants with COVID-19 within 21 Days of Detection [ Time Frame: Baseline through Week 8 ]Percentage of Participants with COVID-19 within 21 Days of Detection
Secondary Outcome Measures :
- Percentage of Participants with Moderate or Worse Severity COVID-19 within 21 Days of Detection [ Time Frame: Baseline through Week 8 ]Percentage of Participants with Moderate or Worse Severity COVID-19 within 21 Days of Detection
- Percentage of Participants with SARS-CoV-2 [ Time Frame: Baseline through 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 LY3819253 Administered Alone [ Time Frame: Day 29 ]PK: Mean Concentration of LY3819253 Administered Alone
- PK: Mean Concentration of LY3819253 in the Presence of LY3832479 [ Time Frame: Day 29 ]PK: Mean Concentration of LY3819253 in the Presence of LY3832479
- PK: Mean Concentration of LY3832479 in the Presence of LY3819253 [ Time Frame: Day 29 ]PK: Mean Concentration of LY3832479 in the Presence of LY3819253
Information from the National Library of Medicine
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 |
Criteria
Inclusion Criteria:
- For 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:
- Recovered from confirmed COVID-19 disease or asymptomatic infection
- A prior history of a positive SARS-CoV-2 serology test
- A 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
Information from the National Library of Medicine
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
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | Clinicaltrials.gov@lilly.com |
Locations
Show 26 study locations
Sponsors and Collaborators
Eli Lilly and Company
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Investigators
| 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 |
Additional Information:
| 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 |
| Last Update Posted: | January 22, 2021 |
| Last Verified: | January 2021 |
| 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 |
Keywords provided by Eli Lilly and Company:
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Prevention |
Additional relevant MeSH terms:
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Infection |