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

  • STATUS
    Recruiting
  • End date
    Jun 24, 2022
  • participants needed
    577
  • sponsor
    Eli Lilly and Company
Updated on 28 July 2021
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
Massachusetts General Hospital (6.0 mi away) Contact
+213 other location
fever
myalgia
dyspnea
covid-19
cough
pharyngitis
headache
sore throat

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.

Details
Condition *COVID-19, Covid-19
Treatment Placebo, LY3819253, LY3832479
Clinical Study IdentifierNCT04427501
SponsorEli Lilly and Company
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

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
Have a body mass index (BMI) 35
Are 65 years of age
Have chronic kidney disease (CKD)
Have type 1 or type 2 diabetes
Are currently receiving immunosuppressive treatment or
Have immunosuppressive disease
cardiovascular disease (CVD), OR
Are 55 years of age AND have
chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
hypertension, OR
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>
Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
Are pregnant
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 immunosuppressive disease, or
Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
Are currently receiving immunosuppressive treatment
Have type 1 or type 2 diabetes
Have chronic kidney disease
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
Have a BMI 85th percentile for their age and gender based on CDC growth charts, <https://www.cdc.gov/growthcharts/clinical_charts.htm>
Are pregnant
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 asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control
Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Have type 1 or type 2 diabetes
Have immunosuppressive disease, or
Have chronic kidney disease
Are less than (<) one year of age
Are currently receiving immunosuppressive treatment, or
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 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 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
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 received convalescent COVID-19 plasma treatment
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
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