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A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)

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ClinicalTrials.gov Identifier: NCT04427501
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 9, 2020
First Posted Date  ICMJE June 11, 2020
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE June 17, 2020
Actual Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • Percentage of Participants Who Experience COVID-Related Hospitalization or Death from Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-Related Hospitalization or Death from Any Cause
  • Change from Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [ Time Frame: Baseline, Day 11 ]
    Change from Baseline to Day 11 in SARS-CoV-2 Viral Load
  • Percentage of Participants with SARS-CoV-2 Viral Load Greater than a Prespecified Threshold [ Time Frame: Day 7 ]
    Percentage of Participants with SARS-CoV-2 Viral Load Greater than a Prespecified Threshold
  • Pharmacokinetics (PK): Area Under the Concentration-time Curve from 0 to Infinity (AUC0-inf) for both LY3819253 and LY3832479 [ Time Frame: Baseline through Day 85 ]
    PK: AUC0-inf for both LY3819253 and LY3832479
  • Percentage of Participants who Experience a Serious Adverse Event(s) SAE(s) [ Time Frame: Baseline through Day 85 ]
    Percentage of Participants who Experience an SAE(s)
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
Change from Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [ Time Frame: Baseline, Day 11 ]
Change from Baseline to Day 11 in SARS-CoV-2 Viral Load
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization [ Time Frame: Baseline, Day 11 ]
    Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization
  • Percentage of Participants Demonstrating Symptom Resolution [ Time Frame: Day 11 ]
    Percentage of Participants Demonstrating Symptom Resolution
  • Percentage of Participants Demonstrating Symptom Improvement [ Time Frame: Day 11 ]
    Percentage of Participants Demonstrating Symptom Improvement
  • Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3819253 in the Presence of LY3832479 [ Time Frame: Day 29 ]
    PK: Mean Concentration of LY3819253 and LY3819253 in the Presence of LY3832479
  • PK: Mean Concentration of LY3832479 in the Presence of LY3819253 [ Time Frame: Day 29 ]
    PK: Mean Concentration of LY3832479 in the Presence of LY3819253
  • Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death from Any Cause [ Time Frame: Baseline through Day 85 ]
    Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
  • 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 Enrolled with Recent Symptoms Prior to Randomization Who Experience COVID-Related Hospitalization or Death from Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Enrolled with Recent Symptoms Prior to Randomization Who Experience COVID-Related Hospitalization or Death from Any Cause
  • Time to Sustained Symptom Resolution [ Time Frame: Baseline through Day 29 ]
    Time to Sustained Symptom Resolution
  • Time to SARS-CoV-2 Viral Clearance [ Time Frame: Baseline through Day 29 ]
    Time to SARS-CoV-2 Viral Clearance
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization [ Time Frame: Baseline, Day 11 ]
    Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization
  • Pharmacokinetics (PK): Mean Concentration of LY3819253 [ Time Frame: Day 29 ]
    PK: Mean Concentration of LY3819253
  • Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness
Official Title  ICMJE A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness
Brief Summary The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 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 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Some treatment arms are open label.
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: LY3819253
    Administered IV or SQ
    Other Names:
    • LY-CoV555
    • Bamlanivimab
  • Drug: LY3832479
    Administered IV or SQ
    Other Names:
    • LY-CoV016
    • Etesevimab
  • Drug: Placebo
    Administered IV
Study Arms  ICMJE
  • Experimental: LY3819253
    LY3819253 administered intravenously (IV)
    Intervention: Drug: LY3819253
  • Experimental: LY3819253 + LY3832479
    LY3819253 + LY3832479 administered IV or subcutaneously (SQ)
    Interventions:
    • Drug: LY3819253
    • Drug: LY3832479
  • Placebo Comparator: Placebo
    Placebo administered IV
    Intervention: Drug: Placebo
Publications *

*   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: March 24, 2021)
3160
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2020)
400
Estimated Study Completion Date  ICMJE May 31, 2021
Actual Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)
  • 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. (Not applicable to participants in treatment arm 22.)
  • Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
  • Are males or females, including pregnant females who agree to contraceptive requirements
  • Understand and agree to comply with planned study procedures
  • Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to participants in treatment arms 20-21.)
  • The participant or legally authorized representative give signed informed consent and/or assent

Participants in treatment arms 7-9, 13-14, and 18-21 ONLY

  • Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening

    • Are pregnant
    • Are ≥65 years of age
    • Have a body mass index (BMI) ≥35
    • Have chronic kidney disease (CKD)
    • 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 (CVD), OR
      • hypertension, OR
      • chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
  • Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening

    • Are pregnant
    • Have a body mass index (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

Participants in treatment arm 22 ONLY

- Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening

  • Are pregnant
  • 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, autism, or Down syndrome (FAIR Health 2020; Spreat et al. 2020)
  • Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
  • Have asthma, cystic fibrosis, reactive airways disease 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, or
  • Are less than (<) one year of age.
  • Have one or more COVID-19 symptoms

    • Shortness of breath/difficulty breathing
    • Fever
    • Sore throat
    • Nausea
    • Diarrhea
    • Tiredness
    • Headache
    • New loss of taste
    • Nasal congestion/runny nose
    • Chills
    • Stomachache
    • Vomiting
    • Cough
    • Muscle/body aches and pain
    • New loss of smell
    • Poor appetite or poor feeding (in babies)

Exclusion Criteria:

  • 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) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19
  • Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
  • 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 received convalescent COVID-19 plasma treatment
  • 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
  • Mothers who are breast feeding

Participants in Treatment Arm 22 ONLY

  • Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the opinion of the investigator
  • Are currently hospitalized for treatment of COVID-19. Other reasons for hospitalization are acceptable.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, 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 Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04427501
Other Study ID Numbers  ICMJE 17947
J2W-MC-PYAB ( 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
Product Manufactured in and Exported from the U.S.: Yes
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.
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 April 2021

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