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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

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

NCT ID

NCT04701658

First Posted

January 7, 2021

Last Updated

November 11, 2021

Sponsor

Eli Lilly and Company

Collaborators

AbCellera Biologics Inc.

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

Data Monitoring Committee

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

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

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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