Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
