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A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)

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ClinicalTrials.gov Identifier: NCT04634409
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : July 21, 2021
Sponsor:
Collaborators:
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
GlaxoSmithKline
Vir Biotechnology, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 17, 2020
First Posted Date  ICMJE November 18, 2020
Last Update Posted Date July 21, 2021
Actual Study Start Date  ICMJE October 29, 2020
Estimated Primary Completion Date August 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
Percentage of Participants with SARS-CoV-2 Viral Load Greater than 5.27 [ Time Frame: Day 7 ]
Percentage of Participants with SARS-CoV-2 Viral Load Greater than 5.27
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
  • 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
  • Change from Baseline to Day 7 in SARS-CoV-2 Viral Load [ Time Frame: Baseline, Day 7 ]
    Change from Baseline to Day 7 in SARS-CoV-2 Viral Load
  • Percentage of Participants Demonstrating Symptom Resolution [ Time Frame: Day 7 ]
    Percentage of Participants Demonstrating Symptom Resolution
  • Percentage of Participants Demonstrating Symptom Improvement [ Time Frame: Day 7 ]
    Percentage of Participants Demonstrating Symptom Improvement
  • Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death [ Time Frame: Baseline through Day 22 ]
    Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
  • Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3832479 [ Time Frame: Day 29 ]
    PK: Mean Concentration of LY3819253 and LY3832479
  • Pharmacokinetics (PK): Mean Concentration of LY3819253 and VIR-7831 [ Time Frame: Day 29 ]
    PK: Mean Concentration of LY3819253 and VIR-7831
  • Pharmacokinetics (PK): Mean Concentration of LY3853113, LY3819253 and LY3832479 [ Time Frame: Day 29 ]
    PK: Mean Concentration of LY3853113, LY3819253 and LY3832479
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
  • 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
  • Change from Baseline to Day 7 in SARS-CoV-2 Viral Load [ Time Frame: Baseline, Day 7 ]
    Change from Baseline to Day 7 in SARS-CoV-2 Viral Load
  • Percentage of Participants Demonstrating Symptom Resolution [ Time Frame: Day 7 ]
    Percentage of Participants Demonstrating Symptom Resolution
  • Percentage of Participants Demonstrating Symptom Improvement [ Time Frame: Day 7 ]
    Percentage of Participants Demonstrating Symptom Improvement
  • Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death [ Time Frame: Baseline through Day 22 ]
    Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
  • Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3832479 [ Time Frame: Day 29 ]
    Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3832479
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
Official Title  ICMJE A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
Brief Summary The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Includes open label arms
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: LY3819253
    Administered IV.
    Other Names:
    • LY-CoV555
    • Bamlanivimab
  • Drug: LY3832479
    Administered IV.
    Other Names:
    • LY-CoV016
    • Etesevimab
  • Drug: Placebo
    Administered IV.
  • Drug: VIR-7831
    Administered IV.
    Other Name: GSK4182136
  • Drug: LY3853113
    Administered IV.
    Other Name: LY-CoV1404
Study Arms  ICMJE
  • Experimental: LY3819253 + LY3832479
    LY3819253 + LY3832479 administered IV.
    Interventions:
    • Drug: LY3819253
    • Drug: LY3832479
  • Experimental: LY3819253
    LY3819253 administered IV.
    Intervention: Drug: LY3819253
  • Placebo Comparator: Placebo
    Placebo administered IV.
    Intervention: Drug: Placebo
  • Experimental: LY3819253 + VIR-7831
    LY3819253 + VIR-7831 administered IV.
    Interventions:
    • Drug: LY3819253
    • Drug: VIR-7831
  • Experimental: LY3853113
    LY3853113 administered IV.
    Intervention: Drug: LY3853113
  • Experimental: LY3853113 + LY3819253 + LY3832479
    LY3853113 + LY3819253 + LY3832479 administered IV.
    Interventions:
    • Drug: LY3819253
    • Drug: LY3832479
    • Drug: LY3853113
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2021)
1556
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2020)
500
Estimated Study Completion Date  ICMJE November 4, 2021
Estimated Primary Completion Date August 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than (<)65 years of age at the time of randomization and do not have the risk factors defined in the bullet point directly below
  • For high-risk participant arms 12 and 13 only:

    -- Are ≥18 years of age and satisfy at least one of the following risk factors at the time of screening

    • Are ≥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
  • For high-risk participant arms 12 and 13 only:

    • Are 12-17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening

      • Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
      • Have sickle cell disease
      • Have congenital or acquired heart disease
      • Have neurodevelopmental disorders, for example, cerebral palsy
      • Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
      • Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
      • Have type 1 or type 2 diabetes
      • Have chronic kidney disease
      • Have immunosuppressive disease, or
      • Are currently receiving immunosuppressive treatment.

For high-risk participants arm 14 only:

  • Are ≥12 years of age and satisfy at least one of the following risk factors at the time of screening Are ≥65 years of age
  • Are adults (≥18 years of age) with BMI >25 kg/m2 , or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts
  • Have chronic kidney disease
  • Have type 1 or type 2 diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Have cardiovascular disease (including congenital heart disease) or hypertension
  • Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
  • Have sickle cell disease
  • Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
  • Have a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]
  • Are currently not hospitalized
  • Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion, nasal congestion or runny nose, new loss of smell, chills
  • Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
  • Are men or non-pregnant women who agree to contraceptive requirements
  • Understand and agree to comply with planned study procedures
  • Agree to the collection of nasopharyngeal swabs and venous blood
  • The participant or legally authorized representative give signed informed consent and/or assent

Exclusion Criteria:

  • For low-risk participants only: BMI ≥35
  • Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
  • 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
  • Have hemodynamic instability requiring use of pressors within 24 hours of randomization
  • 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 co-morbidity 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 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
  • Have a history of convalescent COVID-19 plasma treatment
  • For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
  • 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 pregnant or breast feeding
  • Are investigator site personnel directly affiliated with this study
  • Have body weight <40 kilograms
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Argentina,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04634409
Other Study ID Numbers  ICMJE 18160
J2X-MC-PYAH ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE
  • AbCellera Biologics Inc.
  • Shanghai Junshi Bioscience Co., Ltd.
  • GlaxoSmithKline
  • Vir Biotechnology, Inc.
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date July 2021

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