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Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Collaborating Sponsors:

AbCellera Biologics Inc.

Shanghai Junshi Bioscience Co., Ltd.

Conditions:

COVID-19

Eligibility:

All Genders

Phase:

PHASE2

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 17 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 21 2023

Estimated Enrollment :

3307 Patients enrolled

Trial Details

Trial ID

NCT04427501

Start Date

June 17 2020

End Date

February 21 2023

Last Update

April 11 2024

Active Locations (12)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

1

Clinnova Research - Redondo Beach

Redondo Beach, California, United States, 90277

2

Bio-Medical Research, LLC

Miami, Florida, United States, 33184

3

Rophe Adult and Pediatric Medicine

Union City, Georgia, United States, 30291

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114