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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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: NCT04427501 |
Recruitment Status :
Recruiting
First Posted : June 11, 2020
Last Update Posted : January 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: LY3819253 Drug: LY3832479 Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2450 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | November 17, 2019 |
Actual Primary Completion Date : | September 20, 2020 |
Estimated Study Completion Date : | April 30, 2021 |
Arm | Intervention/treatment |
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Experimental: LY3819253
LY3819253 administered intravenously (IV)
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Drug: LY3819253
Administered IV
Other Names:
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Experimental: LY3819253 + LY3832479
LY3819253 + LY3832479 administered IV
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Drug: LY3819253
Administered IV
Other Names:
Drug: LY3832479 Administered IV
Other Names:
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Placebo Comparator: Placebo
Placebo administered IV
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Drug: Placebo
Administered IV |
- 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 Who Experience COVID-Related Hospitalization or Death [ Time Frame: Baseline through Day 29 ]Percentage of Participants Who Experience COVID-Related Hospitalization or Death
- 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
- 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 [ Time Frame: Baseline through Day 85 ]Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, 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 Enrolled with Recent Symptoms Prior to Randomization Who Experience COVID-Related Hospitalization or Death [ Time Frame: Baseline through Day 29 ]Percentage of Participants Enrolled with Recent Symptoms Prior to Randomization Who Experience COVID-Related Hospitalization or Death

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.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
- Are males or non-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
- The participant or legally authorized representative give signed informed consent and/or assent
Participants in treatment arms 7 and 8 ONLY
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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 ≥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
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Are ≥55 years of age AND have:
- cardiovascular disease (CVD), OR
- hypertension, OR
- chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
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Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
- 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
- Have type 1 or type 2 diabetes
- Have chronic kidney disease
- Have immunosuppressive disease, or
- Are currently receiving immunosuppressive treatment
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
- 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
- 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 pregnant or breast feeding
- Have body weight <40 kilograms (kg)

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): NCT04427501
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 |

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04427501 |
Other Study ID Numbers: |
17947 J2W-MC-PYAB ( Other Identifier: Eli Lilly and Company ) |
First Posted: | June 11, 2020 Key Record Dates |
Last Update Posted: | January 8, 2021 |
Last Verified: | January 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/ |
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 |