COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04427501

Not reported

Not reported

2020-06-11

Completed

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

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 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

4

Eli Lilly and Company

0

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

3307

Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load;Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s);Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups;Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo

None

Phase 2/Phase 3

[{"arm_notes": "nan", "treatment_id": 179, "treatment_name": "Bamlanivimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2252, "treatment_name": "Bamlanivimab+ly3832479", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1861, "treatment_name": "Bebtelovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]