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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated
by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04701658

Recruitment Status  : Completed

First Posted  : January 8, 2021
Results First Posted  : November 16, 2021
Last Update Posted  : November 16, 2021

Sponsor:
Eli Lilly and Company

Collaborator:

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AbCellera Biologics Inc.

Information provided by (Responsible Party):

Eli Lilly and Company

Study Details Tabular View Study Results Disclaimer How to Read a Study Record

Tracking Information
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First Submitted Date January 7, 2021

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First Posted Date January 8, 2021

Results First Submitted Date November 11, 2021

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Results First Posted Date November 16, 2021

Last Update Posted Date November 16, 2021

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Actual Study Start Date February 1, 2021

Actual Primary Completion Date June 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome
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Measures
(submitted: November 11, 2021)
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Days 29, 60, and
90 ]
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24
hours of acute care.

Original Primary Outcome Percentage of Participants who Experience COVID-19 Related Hospitalization or Death [ Time Frame: Baseline through Day 29 ]
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Measures
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death
(submitted: January 7, 2021)

Change History Complete list of historical versions of study NCT04701658 on ClinicalTrials.gov Archive Site

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Current Secondary Outcome

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• Percentage of Participants With a COVID-19-related Hospitalization [ Time Frame: Baseline through Days 29, 60, and 90 ]
Measures
(submitted: November 11, 2021) Hospitalization is defined as ≥24 hours of acute care.

• Percentage of Participants With a COVID-related Emergency Department (ED) Visit [ Time Frame: Baseline through Days 29, 60, and 90 ]

Percentage of Participants with a COVID-related ED Visit.

Original Secondary Outcome

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• Proportion of Participants with a COVID-19-related Hospitalization, Defined as up to Days 60 and 90 [ Time Frame: Baseline through Day 60
Measures
(submitted: January 7, 2021)
and Day 90 ]

• Proportion of Participants with a COVID-related Emergency Department (ED) Visit Through Days 29, 60, and 90 [ Time Frame: Baseline
through Days 29, 60, and 90 ]

Proportion of Participants with a COVID-related ED Visit Through Days 29, 60, and 90

Current Other Pre-specified Not Provided

Outcome Measures

Original Other Pre-specified Not Provided

Outcome Measures

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

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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

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.

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Detailed Description Not Provided

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Study Type Interventional

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Study Phase Phase 2

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Study Design Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Condition COVID-19

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Intervention Drug: Bamlanivimab
Administered intravenously.
Other Names:
• LY3819253
• LY-CoV555

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Study Arms
• Experimental: Bamlanivimab
Participants received 700 milligram single intravenous infusion of Bamlanivimab.
Intervention: Drug: Bamlanivimab

• No Intervention: Controls
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.]

Publications * 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:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
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Recruitment Status Completed

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Actual Enrollment 109
(submitted: October 6, 2021)

Original Estimated Enrollment 5000

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(submitted: January 7, 2021)

Actual Study Completion Date June 22, 2021

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Actual Primary Completion Date June 22, 2021 (Final data collection date for primary outcome measure)

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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:

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◦ 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.

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Sex/Gender Sexes Eligible for Study: All

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Ages 12 Years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers No

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Contacts Contact information is only displayed when the study is recruiting subjects

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Listed Location Countries United States

Removed Location Countries

Administrative Information
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NCT Number NCT04701658

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Other Study ID Numbers 18216
J2X-MC-PYAJ ( Other Identifier: Eli Lilly and Company )

Has Data Monitoring Committee No

U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes

Studies a U.S. FDA-regulated Device Product: No

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IPD Sharing Statement Plan to Share IPD:
Plan Description:
Supporting Materials:
Supporting Materials:
Supporting Materials:
Time Frame:
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.
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Data are available 6 months after the primary publication and approval of the indication studied in the US and

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European Union (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: http://vivli.org/

Responsible Party Eli Lilly and Company

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Study Sponsor Eli Lilly and Company

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Collaborators AbCellera Biologics Inc.

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Investigators Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time Eli Lilly and
(UTC/GMT - 5 hours, EST) Company

PRS Account Eli Lilly and Company

Verification Date November 2021

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Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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