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Trial record 2 of 14 for:    Bamlanivimab

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04701658
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
AbCellera Biologics Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Bamlanivimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : June 7, 2021
Estimated Study Completion Date : August 7, 2021

Arm Intervention/treatment
Experimental: Bamlanivimab
Bamlanivimab administered intravenously (IV).
Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY3819253
  • LY-CoV555

No Intervention: Controls
Matched controls who received standard of care.



Primary Outcome Measures :
  1. Percentage of Participants who Experience COVID-19 Related Hospitalization or Death [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants who Experience COVID-19 Related Hospitalization or Death


Secondary Outcome Measures :
  1. Proportion of Participants with a COVID-19-related Hospitalization, Defined as up to Days 60 and 90 [ Time Frame: Baseline through Day 60 and Day 90 ]
  2. 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



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.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04701658


Contacts
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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
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United States, New Mexico
Presbyterian Medical Center Recruiting
Albuquerque, New Mexico, United States, 87110
Contact    505-205-2344      
Principal Investigator: Norbert Topf         
Sponsors and Collaborators
Eli Lilly and Company
AbCellera Biologics Inc.
Investigators
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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:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04701658    
Other Study ID Numbers: 18216
J2X-MC-PYAJ ( Other Identifier: Eli Lilly and Company )
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: 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.
URL: http://vivli.org/

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