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A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (BLAZE-5)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bamlanivimab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are currently not hospitalized.
  • Have one or more mild or moderate COVID-19 symptoms.
  • Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset
  • Are males or non-breastfeeding females.
  • Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies.
  • Are at high risk for progressing to severe COVID-19 and/or hospitalization.

Exclusion Criteria:

  • Participants who:

    • are hospitalized due to COVID-19, OR
    • require oxygen therapy due to COVID-19, OR
    • require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
  • Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute.
  • Have body weight <40 kilograms.
  • Require mechanical ventilation or anticipated impending need for mechanical ventilation.
  • Have known allergies to any of the components used in the formulation of the interventions.
  • Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.
  • Have any comorbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days.
  • Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
  • Have a history of a positive SARS-CoV-2 serology test.
  • Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
  • Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
  • Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-19.
  • Have received convalescent COVID-19 plasma treatment.
  • Have participated in a previous SARS-CoV-2 vaccine study.
  • Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
  • Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Are breast-feeding.

Sites / Locations

  • Presbyterian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bamlanivimab

Controls

Arm Description

Participants received 700 milligram single intravenous infusion of Bamlanivimab.

Matched controls who received standard of care. [The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.]

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.

Secondary Outcome Measures

Percentage of Participants With a COVID-19-related Hospitalization
Hospitalization is defined as ≥24 hours of acute care.
Percentage of Participants With a COVID-related Emergency Department (ED) Visit
Percentage of Participants with a COVID-related ED Visit.

Full Information

First Posted
January 7, 2021
Last Updated
November 11, 2021
Sponsor
Eli Lilly and Company
Collaborators
AbCellera Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04701658
Brief Title
A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Acronym
BLAZE-5
Official Title
A Prospective Cohort Study to Evaluate the Real-world Effectiveness of Bamlanivimab in Participants With Mild-to-moderate COVID-19 at High Risk for Progressing to Severe Illness, With Matched Controls
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
AbCellera Biologics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bamlanivimab
Arm Type
Experimental
Arm Description
Participants received 700 milligram single intravenous infusion of Bamlanivimab.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Matched controls who received standard of care. [The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.]
Intervention Type
Drug
Intervention Name(s)
Bamlanivimab
Other Intervention Name(s)
LY3819253, LY-CoV555
Intervention Description
Administered intravenously.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Description
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.
Time Frame
Baseline through Days 29, 60, and 90
Secondary Outcome Measure Information:
Title
Percentage of Participants With a COVID-19-related Hospitalization
Description
Hospitalization is defined as ≥24 hours of acute care.
Time Frame
Baseline through Days 29, 60, and 90
Title
Percentage of Participants With a COVID-related Emergency Department (ED) Visit
Description
Percentage of Participants with a COVID-related ED Visit.
Time Frame
Baseline through Days 29, 60, and 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are currently not hospitalized. Have one or more mild or moderate COVID-19 symptoms. Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset Are males or non-breastfeeding females. Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies. Are at high risk for progressing to severe COVID-19 and/or hospitalization. Exclusion Criteria: Participants who: are hospitalized due to COVID-19, OR require oxygen therapy due to COVID-19, OR require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute. Have body weight <40 kilograms. Require mechanical ventilation or anticipated impending need for mechanical ventilation. Have known allergies to any of the components used in the formulation of the interventions. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention. Have any comorbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. Have a history of a positive SARS-CoV-2 serology test. Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing. Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-19. Have received convalescent COVID-19 plasma treatment. Have participated in a previous SARS-CoV-2 vaccine study. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Are breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Presbyterian Medical Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Citations:
PubMed Identifier
34473343
Citation
Kreuzberger 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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/7zjYxdhUwux6y1A18CmrFJ
Description
A Real World Study of Bamlanivimab in Participants With Mild-to-moderate Coronavirus Disease 2019 (COVID-19) (BLAZE-5)

Learn more about this trial

A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

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