COVID-19Phase 3BLAZE-2NCT04497987
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
A Phase 3 study testing Bamlanivimab and Etesevimab in people with COVID-19 and SARS-CoV2, run by Eli Lilly and Company at 27 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Bamlanivimab and Etesevimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,180 participants
- Where
- 27 sitesUnited States
- Study dates
- 2 Aug 2020to 20 May 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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 locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
University of Colorado-Anschultz Medical Campus
Aurora, Colorado, 80045
Donahoe Manor
Bedford, Pennsylvania, 15522
Allergy and Asthma Clin of NW Ark
Bentonville, Arkansas, 72712
NIAID - National Institute of Allergy & Infectious Diseases
Bethesda, Maryland, 20892
Unv of AL Sch of Med Div of Infectious Diseases
Birmingham, Alabama, 35294
Care Access
Boston, Massachusetts, 02110
Burke Internal Medicine and Research
Burke, Virginia, 22015
Valley Medical Primary Care
Centerville, Ohio, 45459
NIAD
Chapel Hill, North Carolina, 27599
Univ of Cin College of Med
Cincinnati, Ohio, 45219
NIAID
Decatur, Georgia, 30030
Belmont Village, West Univ
Houston, Texas, 77025
Care Access Research LLC
Huntington Beach, California, 92648
Family Medicine
Indianapolis, Indiana, 46260
Care Access
Jackson, Mississippi, 39206
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Care Access Rch Lake Charles
Lake Charles, Louisiana, 70601
Belmont Village Lincoln Park
Lincoln Park, Illinois, 60614
University of Louisville
Louisville, Kentucky, 40202
NIAID
Miami, Florida, 33136
Tulane University School of Medicine
New Orleans, Louisiana, 70112 2715
Alta Bates SMC
Oakland, California, 94609
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
Care Access Research
Phoenix, Arizona, 85023
St. Paul IDA-CARe
Saint Paul, Minnesota, 55101
Care Access Research - Bronx
The Bronx, New York, 10456
OSU Med Intl Med Houston Ctr
Tulsa, Oklahoma, 74127
About this study
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
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.
- Being tested
- Bamlanivimab, Placebo, Etesevimab
- Keywords
- Prevention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BamlanivimabDrug
Also called LY-CoV555, LY3819253
Administered IV.
PlaceboDrug
Administered IV.
EtesevimabDrug
Also called LY-CoV016, LY3832479
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Bamlanivimab (Part 1) | Experimental | Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab. Receives: Drug: Bamlanivimab |
| Placebo (Part 1) | Placebo comparator | Participants received single IV infusion of Placebo. Receives: 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. Receives: 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. Receives: Drug: Bamlanivimab; Drug: 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. Receives: 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. Receives: 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. Receives: Drug: Bamlanivimab; Drug: 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.] Receives: 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.] Receives: Drug: Bamlanivimab; Drug: Etesevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8 after randomization
Secondary outcomes (6)
Percentage of Participants With Moderate or Worse Severity COVID-19
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.
Measured: Week 8 after randomization
Percentage of Participants With SARS-CoV-2
Percentage of Participants with SARS-CoV-2.
Measured: Week 4
Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Measured: Week 8
Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Measured: Week 8
Percentage of Participants Who Die Due to COVID-19
Percentage of Participants Who Die Due to COVID-19.
Measured: Week 8
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Measured: Day 29, 57, 85, 141 and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start2 Aug 2020
- Primary completion16 Jan 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497987
- Sponsor's protocol ID
- 18063
- Other IDs
- J2X-MC-PYAD, CoVPN #3501
- Acronym
- BLAZE-2
- Status last verified
- Feb 2022
- First submitted
- 31 Jul 2020
- Last updated
- 4 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35713300Kreuzberger 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.
PubMed 34473343Nathan 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.
PubMed 34374951Cohen 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.
PubMed 34081073
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04497987
- Acronym / sponsor ID
- BLAZE-2 / 18063
- Keywords
- Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 2 Aug 2020 (actual)
- Primary completion
- 16 Jan 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Posted 4 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Bamlanivimab (Part 1) | Experimental | Drug: BamlanivimabParticipants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab. |
| Placebo (Part 1) | Placebo comparator | Drug: PlaceboParticipants received single IV infusion of Placebo. |
| Bamlanivimab (Part 2-Prevention) | Experimental | Drug: BamlanivimabEnrollment 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) | Experimental | Drug: Bamlanivimab, Drug: EtesevimabEnrollment 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 Comparator: Placebo (Part 2-Prevention) | Placebo comparator | Drug: PlaceboEnrollment 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) | Experimental | Drug: BamlanivimabEnrollment 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) | Experimental | Drug: Bamlanivimab, Drug: EtesevimabEnrollment 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) | Experimental | Drug: BamlanivimabPart 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) | Experimental | Drug: Bamlanivimab, Drug: EtesevimabPart 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.] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (7 listed)
- Parts 1 and 2:
- Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BamlanivimabAlso: LY-CoV555, LY3819253Administered IV. | Drug | 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) |
| PlaceboAdministered IV. | Drug | Placebo (Part 1), Placebo Comparator: Placebo (Part 2-Prevention) |
| EtesevimabAlso: LY-CoV016, LY3832479Administered IV. | Drug | Bamlanivimab + Etesevimab (Part 2- Treatment), Bamlanivimab + Etesevimab (Part 2-Prevention), Bamlanivimab + Etesevimab (Part 3) |
Primary outcome
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.
6 secondary outcomes
Percentage of Participants With Moderate or Worse Severity COVID-19
Time frame: Week 8 after randomization
Percentage of Participants With SARS-CoV-2
Time frame: Week 4
Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
Time frame: Week 8
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 Die Due to COVID-19
Time frame: Week 8
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Time frame: Day 29, 57, 85, 141 and 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35713300Hirsch 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.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Derived from this study: PubMed 34374951Nathan 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.
- Derived from this study: PubMed 34081073Cohen 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.
- A Study of LY3819253 (LY-CoV555) to Prevent SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bamlanivimab and Etesevimab in people with COVID-19 and SARS-CoV2, run by Eli Lilly and Company at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With COVID-19 (time frame: Week 8 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04497987, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.