A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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)
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
Sites / Locations
- Clinnova Research - Redondo Beach
- Bio-Medical Research, LLC
- Rophe Adult and Pediatric Medicine
- Massachusetts General Hospital
- U of MA Mem Med Ctr
- Great Lakes Research Group, Inc.
- Childrens Hospital of Michigan
- Sky Clinical Prime and Health Wellness Clinic
- Sky Clin Resch - Quinn HC
- Monroe Biomed Research
- B S & W Med Center
- Sun Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
LY3819253
LY3819253 + LY3832479
LY3853113 Open Label Addenda Arm 23
Placebo
700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)
350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
Administered IV
Placebo administered IV