A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness
NCT ID: NCT04427501
Last Updated: 2024-04-11
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
3307 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-17
Study Completion Date
2023-02-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
NCT04411628
COVID-19
COMPLETED
PHASE1
A Study of LY3832479 (LY-CoV016) in Healthy Participants
NCT04441931
Healthy
COMPLETED
PHASE1
A Study of LY3819253 (LY-CoV555) in Healthy Participants
NCT04537910
Healthy
COMPLETED
PHASE1
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
NCT04497987
COVID-19
SARS-CoV2
COMPLETED
PHASE3
LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
NCT05780268
COVID-19
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
COVID-19
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Some treatment arms are open label.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LY3819253
700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)
Group Type
EXPERIMENTAL
LY3819253
Intervention Type
DRUG
Administered IV
LY3819253 + LY3832479
350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
Group Type
EXPERIMENTAL
LY3819253
Intervention Type
DRUG
Administered IV
LY3832479
Intervention Type
DRUG
Administered IV
LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)
LY3819253 dose based upon weight (weight Group: ≥40 kilogram (kg) = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and LY3832479 dose based upon weight (weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Group Type
EXPERIMENTAL
LY3819253
Intervention Type
DRUG
Administered IV
LY3832479
Intervention Type
DRUG
Administered IV
LY3853113 (Pediatric Addendum, Arm 23)
LY3853113 dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
Group Type
EXPERIMENTAL
LY3853113
Intervention Type
DRUG
Administered IV
Placebo
Placebo administered IV
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LY3819253
Administered IV
Intervention Type
DRUG
LY3832479
Administered IV
Intervention Type
DRUG
LY3853113
Administered IV
Intervention Type
DRUG
Placebo
Administered IV
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
LY-CoV555
Bamlanivimab
LY-CoV016
Etesevimab
bebtelovimab
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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)
Participants in treatment arm 23 ONLY:
Must have first positive result sample of current SARS-CoV-2 viral infection ≤3 days prior to start of treatment administration.
Participant can have COVID previously and still meet criteria for this addendum. Positive result needs to be from a current infection.
Are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to \<12 years of age at the time of screening, or are 12 to 17 and weighing \<40 kg; and
* Have mild to moderate COVID-19 disease, including one or more COVID-19 symptoms within the last 7 days
* Shortness of breath/difficulty breathing
* Fever
* Sore throat
* Nausea
* Diarrhea
* Tiredness
* Headache
* New loss of taste
* Nasal congestion/runny nose
* Chills
* Malaise
* Vomiting
* Cough
* Muscle/body aches and pain
* New loss of smell
* Poor appetite or poor feeding (in babies under 1 year old)
* 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)
Participants in treatment arm 23 ONLY:
Must have first positive result sample of current SARS-CoV-2 viral infection ≤3 days prior to start of treatment administration.
Participant can have COVID previously and still meet criteria for this addendum. Positive result needs to be from a current infection.
Are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to \<12 years of age at the time of screening, or are 12 to 17 and weighing \<40 kg; and
* Have mild to moderate COVID-19 disease, including one or more COVID-19 symptoms within the last 7 days
* Shortness of breath/difficulty breathing
* Fever
* Sore throat
* Nausea
* Diarrhea
* Tiredness
* Headache
* New loss of taste
* Nasal congestion/runny nose
* Chills
* Malaise
* Vomiting
* Cough
* Muscle/body aches and pain
* New loss of smell
* Poor appetite or poor feeding (in babies under 1 year old)
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 in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine
* 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.
Participants in treatment arm 23 ONLY
* SpO2 ≤ 93% on room air at sea level, or while on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity, respiratory rate ≥30 per minute, and heart rate ≥125 per minute due to COVID-19 (FDA February 2021)
* 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 received treatment with a SARS-CoV-2 specific monoclonal antibody or remdesivir within 90 days before dosing.
* Have received convalescent COVID-19 plasma treatment within 90 days before dosing
* 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 currently pregnant or breast feeding
* 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 in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine
* 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.
Participants in treatment arm 23 ONLY
* SpO2 ≤ 93% on room air at sea level, or while on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity, respiratory rate ≥30 per minute, and heart rate ≥125 per minute due to COVID-19 (FDA February 2021)
* 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 received treatment with a SARS-CoV-2 specific monoclonal antibody or remdesivir within 90 days before dosing.
* Have received convalescent COVID-19 plasma treatment within 90 days before dosing
* 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 currently pregnant or breast feeding
Minimum Eligible Age
0 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
AbCellera Biologics Inc.
INDUSTRY
Sponsor Role
collaborator
Shanghai Junshi Bioscience Co., Ltd.
OTHER
Sponsor Role
collaborator
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinnova Research - Redondo Beach
Redondo Beach, California, United States
Site Status
Bio-Medical Research, LLC
Miami, Florida, United States
Site Status
Rophe Adult and Pediatric Medicine
Union City, Georgia, United States
Site Status
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
U of MA Mem Med Ctr
Worcester, Massachusetts, United States
Site Status
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Site Status
Childrens Hospital of Michigan
Detroit, Michigan, United States
Site Status
Sky Clinical Prime and Health Wellness Clinic
Fayette, Mississippi, United States
Site Status
Sky Clin Resch - Quinn HC
Ridgeland, Mississippi, United States
Site Status
Monroe Biomed Research
Monroe, North Carolina, United States
Site Status
B S & W Med Center
Dallas, Texas, United States
Site Status
Sun Research Institute
San Antonio, Texas, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Patel DR, Macpherson L, Bohm M, Upadhyaya H, Deveau C, Nirula A, Klekotka P, Williams M, Hufford MM. Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19. Infect Dis Ther. 2024 Oct;13(10):2123-2134. doi: 10.1007/s40121-024-01031-z. Epub 2024 Sep 4.
Reference Type
DERIVED
Upadhyaya HP, Chien JY, Long AJ, Bohm MS, Kallewaard NL, Macpherson LF, Patel DR, Hufford MM, Krull CJ, Ang JY, Chen P, Muller WJ, Potts JA, Quinn T, Williams M; BLAZE-1 Investigators. Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial. Infect Dis Ther. 2023 Jul;12(7):1861-1873. doi: 10.1007/s40121-023-00832-y. Epub 2023 Jun 17.
Reference Type
DERIVED
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Reference Type
DERIVED
Chen P, Behre G, Hebert C, Kumar P, Farmer Macpherson L, Graham-Clarke PL, De La Torre I, Nichols RM, Hufford MM, Patel DR, Naegeli AN. Bamlanivimab and Etesevimab Improve Symptoms and Associated Outcomes in Ambulatory Patients at Increased Risk for Severe Coronavirus Disease 2019: Results From the Placebo-Controlled Double-Blind Phase 3 BLAZE-1 Trial. Open Forum Infect Dis. 2022 Apr 7;9(5):ofac172. doi: 10.1093/ofid/ofac172. eCollection 2022 May.
Reference Type
DERIVED
Dougan M, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Blomkalns A, Adams AC, Van Naarden J, Custer KL, Knorr J, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Sabo J, Patel DR, Dabora MC, Williams M, Klekotka P, Shen L, Skovronsky DM, Nirula A. A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load. Clin Infect Dis. 2022 Aug 24;75(1):e440-e449. doi: 10.1093/cid/ciab912.
Reference Type
DERIVED
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(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Reference Type
DERIVED
Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.
Reference Type
DERIVED
Meng X, Wang P, Xiong Y, Wu Y, Lin X, Lu S, Li R, Zhao B, Liu J, Zeng S, Zeng L, Wu Y, Lu Y, Zhang J, Liu D, Wang S, Lu H. Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 10.1080/22221751.2021.1960900.
Reference Type
DERIVED
Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Dabora MC, Klekotka P, Shen L, Skovronsky DM; BLAZE-1 Investigators. Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19. N Engl J Med. 2021 Oct 7;385(15):1382-1392. doi: 10.1056/NEJMoa2102685. Epub 2021 Jul 14.
Reference Type
DERIVED
Gottlieb RL, Nirula A, Chen P, Boscia J, Heller B, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Klekotka P, Shen L, Skovronsky DM. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):632-644. doi: 10.1001/jama.2021.0202.
Reference Type
DERIVED
Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Adams AC, Van Naarden J, Custer KL, Shen L, Durante M, Oakley G, Schade AE, Sabo J, Patel DR, Klekotka P, Skovronsky DM; BLAZE-1 Investigators. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):229-237. doi: 10.1056/NEJMoa2029849. Epub 2020 Oct 28.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol: Protocol J2W-MC-PYAB (m)
Document Type: Study Protocol: PYAB 05 Protocol Addenda (2.2)
Document Type: Study Protocol: J2W-MC-PYAB Addendum (4.2)
Document Type: Statistical Analysis Plan: J2W-MC-PYAB Statistical Analysis Plan (V8)
Document Type: Statistical Analysis Plan: J2W-MC-PYAB Statistical Analysis Plan Version 9
Document Type: Statistical Analysis Plan: J2W-MC-PYAB Statistical Analysis Plan A ddendum 4
Related Links
Access external resources that provide additional context or updates about the study.
https://trials.lillytrialguide.com/en-US/trial/63aASRmBPQCBCOfy5oO0er
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
J2W-MC-PYAB
Identifier Type: OTHER
Identifier Source: secondary_id
17947
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Study of LY3832479 (LY-CoV016) in Healthy Participants 1
NCT04611789
COMPLETED
PHASE1
Safety and Immunogenicity of COVID-19 Vaccine in Population Aged 18 Years and Above
NCT05552573
UNKNOWN
PHASE1
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
NCT04551898
COMPLETED
PHASE2
Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.
NCT04450004
COMPLETED
PHASE1
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
NCT04368728
COMPLETED
PHASE2/PHASE3
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
NCT04532294
COMPLETED
PHASE1
A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19
NCT04822701
TERMINATED
PHASE2/PHASE3
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
NCT04412538
COMPLETED
PHASE1/PHASE2
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
NCT04449276
COMPLETED
PHASE1
A Phase 1 Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine
NCT06113744
RECRUITING
PHASE1
A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
NCT05505448
COMPLETED
PHASE1
Safety, Reactogenicity, and Immunogenicity Study of a Lyophilized COVID-19 mRNA Vaccine
NCT05366296
WITHDRAWN
PHASE1
Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)
NCT04813562
UNKNOWN
PHASE2
Safety, Reactogenicity and Immunogenicity Study of ReCOV
NCT04818801
COMPLETED
EARLY_PHASE1
A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
NCT04640402
COMPLETED
PHASE2
SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 Patients
NCT06042764
RECRUITING
PHASE2
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
NCT04426695
COMPLETED
PHASE1/PHASE2
A Study of LY2140023 in Healthy Males and Females
NCT01591330
COMPLETED
PHASE1
A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2
NCT04894474
WITHDRAWN
PHASE2/PHASE3
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
NCT06850051
COMPLETED
PHASE1
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19
NCT05216601
COMPLETED
PHASE1
Study of Ameliorating Effect of COVID-19 mRNA Vaccine in Individuals Immunized With Inactivated Vaccine
NCT04944381
UNKNOWN
NA
Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine
NCT04445194
UNKNOWN
PHASE1
Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above
NCT05664932
UNKNOWN
PHASE3