COVID-19
Conditions
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-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. Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021. Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.
Interventions
Sponsors
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Some treatment arms are open label.
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline through Day 29 | COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29. |
| 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 | Day 7 | SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load \>=5.27 vs otherwise. |
| Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load | Baseline, Day 11 | SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless. |
| Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) | Baseline through Day 85 | An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section. |
| Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab) | Day 29 Post-dose | Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary. |
| Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab) | Day 29 Post-dose | Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary. |
| Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23] | Day 60 Post-dose | AUC0-∞ for Bebtelovimab was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization | Baseline, Day 11 | SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis. |
| Phase 2: Percentage of Participants Demonstrating Symptom Resolution | Day 11 | Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise. Missing data were imputed using non-responder imputation (NRI) method. |
| Phase 2: Percentage of Participants Demonstrating Symptom Improvement | Day 11 | Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method. |
| Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab | Day 29 Post-dose | (PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab |
| Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab | Day 29 Post-dose | PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab |
| Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | Baseline through Day 85 | Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause |
| Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22] | Baseline through Day 29 | Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause. |
| Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22] | Baseline, Day 7 | SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Viral load is reported as normalized viral load and is unitless. |
| Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22] | Day 7 | SARS-CoV-2 persistent high viral load (yes/no) is defined as RP normalized viral load \>5.27 vs otherwise. Percentage of response is calculated by n/Nx\*100% (n = number of participants in the specified category, Nx = number of participants with non-missing values) |
| Phase 2/3: Time to Complete Symptom Resolution [Arm 22] | Baseline through Day 29 | Complete symptom resolution was defined as absence of all symptoms at a single timepoint. |
| Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22] | Baseline through Day 29 | Sustained complete symptom resolution is defined as the first of 2 consecutive days with complete symptom resolution. |
| Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22] | Baseline through Day 29 | Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit. |
| Phase 2: Time to SARS-CoV-2 Viral Clearance | Baseline through Day 29 | Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit. |
| Phase 3: Percentage of Participants Demonstrating Symptom Resolution | Day 11 | Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method. |
| Phase 3: Percentage of Participants Demonstrating Symptom Improvement | Day 11 | Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method. |
| Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | Baseline through Day 85 | COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise. |
| Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral and is unitless. |
| Phase 3: Time to Sustained Symptom Resolution | Baseline through Day 29 | Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization. |
| Phase 3: Time to SARS-CoV-2 Viral Clearance | Baseline through Day 29 | Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit. |
Countries
United States
Participant flow
Pre-assignment details
This study has three parts: Phase 2, Phase 3 and pediatrics addendum. All participants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab are also in Placebo For Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab therefore the two arms are combined to avoid double counting.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2: Placebo Participants received Placebo administered intravenously (IV). | 156 |
| Phase 2: 700 mg Bamlanivimab Participants received 700 mg bamlanivimab administered IV. | 101 |
| Phase 2: 2800 mg Bamlanivimab Participants received 2800 mg bamlanivimab administered IV. | 107 |
| Phase 2: 7000 mg Bamlanivimab Participants received 7000 mg bamlanivimab administered IV. | 101 |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV. | 112 |
| Phase 3: Placebo Participants received Placebo administered intravenously (IV). | 776 |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV. | 518 |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV. | 513 |
| Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab Participants received Placebo administered intravenously (IV). | 141 |
| Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV. | 213 |
| Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22) Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV. | 94 |
| Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23) Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV. | 17 |
| Total | 2,849 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 15 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 1 | 2 | 0 | 2 | 11 | 10 | 10 | 2 | 5 | 2 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Other - as reported by the investigator | 1 | 0 | 0 | 0 | 0 | 6 | 6 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 3 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 2 | 2 | 3 | 7 | 25 | 15 | 7 | 4 | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | Phase 2: Placebo | Total | Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23) | Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22) | Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Placebo | Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: 7000 mg Bamlanivimab | Phase 2: 2800 mg Bamlanivimab | Phase 2: 700 mg Bamlanivimab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 15.38 | 51.9 years STANDARD_DEVIATION 16.95 | 26.19 years STANDARD_DEVIATION 15.95 | 9.9 years STANDARD_DEVIATION 4.76 | 52.7 years STANDARD_DEVIATION 17.49 | 53.6 years STANDARD_DEVIATION 15.7 | 54.5 years STANDARD_DEVIATION 16.77 | 54.3 years STANDARD_DEVIATION 17.08 | 53.4 years STANDARD_DEVIATION 16.52 | 43.9 years STANDARD_DEVIATION 16.39 | 45.7 years STANDARD_DEVIATION 16.28 | 44.4 years STANDARD_DEVIATION 14.61 | 43.5 years STANDARD_DEVIATION 16.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 866 Participants | 4 Participants | 13 Participants | 53 Participants | 36 Participants | 139 Participants | 149 Participants | 226 Participants | 42 Participants | 39 Participants | 47 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 1977 Participants | 13 Participants | 80 Participants | 160 Participants | 104 Participants | 373 Participants | 368 Participants | 548 Participants | 70 Participants | 62 Participants | 60 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 15 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 98 Participants | 0 Participants | 0 Participants | 6 Participants | 6 Participants | 18 Participants | 16 Participants | 33 Participants | 2 Participants | 3 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 302 Participants | 12 Participants | 67 Participants | 28 Participants | 16 Participants | 41 Participants | 44 Participants | 61 Participants | 4 Participants | 8 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 12 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 30 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 6 Participants | 7 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 133 Participants | 2386 Participants | 5 Participants | 22 Participants | 175 Participants | 116 Participants | 445 Participants | 449 Participants | 667 Participants | 105 Participants | 89 Participants | 90 Participants | 90 Participants |
| Region of Enrollment United States | 156 Participants | 2849 Participants | 17 Participants | 94 Participants | 213 Participants | 141 Participants | 513 Participants | 518 Participants | 776 Participants | 112 Participants | 101 Participants | 107 Participants | 101 Participants |
| SARS-CoV-2 Viral Load | 23.79 Cycle threshold (Ct) STANDARD_DEVIATION 7.78 | 24.16 Cycle threshold (Ct) STANDARD_DEVIATION 7.75 | 28.79 Cycle threshold (Ct) STANDARD_DEVIATION 7.053 | 26.61 Cycle threshold (Ct) STANDARD_DEVIATION 7.458 | 25.62 Cycle threshold (Ct) STANDARD_DEVIATION 7.33 | 24.29 Cycle threshold (Ct) STANDARD_DEVIATION 6.82 | 24.15 Cycle threshold (Ct) STANDARD_DEVIATION 7.28 | 23.98 Cycle threshold (Ct) STANDARD_DEVIATION 8.22 | 24.26 Cycle threshold (Ct) STANDARD_DEVIATION 8.194 | 22.72 Cycle threshold (Ct) STANDARD_DEVIATION 8.01 | 23.42 Cycle threshold (Ct) STANDARD_DEVIATION 6.78 | 24.47 Cycle threshold (Ct) STANDARD_DEVIATION 7.61 | 23.80 Cycle threshold (Ct) STANDARD_DEVIATION 6.55 |
| Sex: Female, Male Female | 85 Participants | 1491 Participants | 9 Participants | 43 Participants | 108 Participants | 68 Participants | 265 Participants | 279 Participants | 404 Participants | 58 Participants | 58 Participants | 51 Participants | 63 Participants |
| Sex: Female, Male Male | 71 Participants | 1358 Participants | 8 Participants | 51 Participants | 105 Participants | 73 Participants | 248 Participants | 239 Participants | 372 Participants | 54 Participants | 43 Participants | 56 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 156 | 0 / 101 | 0 / 107 | 0 / 101 | 0 / 112 | 0 / 518 | 15 / 776 | 0 / 513 | 0 / 141 | 0 / 213 | 0 / 94 | 0 / 17 |
| other Total, other adverse events | 44 / 156 | 29 / 101 | 26 / 107 | 24 / 101 | 23 / 112 | 72 / 518 | 92 / 776 | 61 / 513 | 17 / 141 | 14 / 213 | 16 / 94 | 4 / 17 |
| serious Total, serious adverse events | 1 / 156 | 2 / 101 | 0 / 107 | 0 / 101 | 1 / 112 | 10 / 518 | 8 / 776 | 16 / 513 | 4 / 141 | 1 / 213 | 1 / 94 | 0 / 17 |
Outcome results
Primary
Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
AUC0-∞ for Bebtelovimab was reported.
Time frame: Day 60 Post-dose
Population: Phase 2/3: All randomized participants who received a complete dose of Bebtelovimab and had at least 1 post-dose PK sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23] | 481 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 45.8 |
Primary
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.
Time frame: Baseline, Day 11
Population: Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load | -3.80 unitless | Standard Error 0.141 |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load | -3.72 unitless | Standard Error 0.17 |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load | -4.08 unitless | Standard Error 0.168 |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load | -3.49 unitless | Standard Error 0.175 |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load | -4.37 unitless | Standard Error 0.169 |
p-value: 0.692195% CI: [-0.35, 0.52]Mixed Models Analysis
p-value: 0.21195% CI: [-0.71, 0.16]Mixed Models Analysis
p-value: 0.16395% CI: [-0.13, 0.76]Mixed Models Analysis
p-value: 0.009995% CI: [-1, -0.14]Mixed Models Analysis
Primary
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Time frame: Baseline through Day 85
Population: Phase 2: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) | 0.6 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) | 0 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) | 0 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) | 0 percentage of participants |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) | 0.9 percentage of participants |
Primary
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Time frame: Day 29 Post-dose
Population: Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab) | Bamlanivimab 700 mg: Weight Group: ≥40 kg | 29.9 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 54.4 |
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab) | Bamlanivimab 350 mg: Weight Group: >20 kg to <40 kg | 23.7 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 45.6 |
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab) | Bamlanivimab 175 mg: Weight Group: >12 kg to 20 kg | 21.2 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 74 |
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab) | Bamlanivimab 15 mg/kg: Weight Group: 1.5 kg to 12 kg | 40.2 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 23.2 |
Primary
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Time frame: Day 29 Post-dose
Population: Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab) | Etesevimab 1400 mg: Weight Group: ≥40 kg | 140 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 44 |
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab) | Etesevimab 700 mg: Weight Group: >20 kg to <40 kg | 129 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 36.7 |
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab) | Etesevimab 350 mg: Weight Group: >12 kg to 20 kg | 122 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 57.3 |
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab) | Etesevimab 30 mg/kg: Weight Group: 1.5 kg to 12 kg | 193 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 11 |
Primary
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
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Time frame: Baseline through Day 29
Population: Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | 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 | 7.0 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | 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 | 2.1 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | 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 | 6.8 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | 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 | 0.8 percentage of participants |
95% CI: [0.15, 0.58]
95% CI: [0.04, 0.31]
Primary
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
SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load \>=5.27 vs otherwise.
Time frame: Day 7
Population: Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | 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 | 34.8 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | 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 | 10.8 percentage of participants |
95% CI: [0.13, 0.4]
Secondary
Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22]
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Viral load is reported as normalized viral load and is unitless.
Time frame: Baseline, Day 7
Population: Phase 2/3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22] | -4.37 unitless | Standard Deviation 2.74 |
Secondary
Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22]
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause.
Time frame: Baseline through Day 29
Population: Phase 2/3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22] | 0 percentage of participants |
Secondary
Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22]
SARS-CoV-2 persistent high viral load (yes/no) is defined as RP normalized viral load \>5.27 vs otherwise. Percentage of response is calculated by n/Nx\*100% (n = number of participants in the specified category, Nx = number of participants with non-missing values)
Time frame: Day 7
Population: Phase 2/3: All randomized participants who received at least one dose of study drug and had a day 7 viral load value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22] | 10.9 percentage of participants |
Secondary
Phase 2/3: Time to Complete Symptom Resolution [Arm 22]
Complete symptom resolution was defined as absence of all symptoms at a single timepoint.
Time frame: Baseline through Day 29
Population: Phase 2/3: All randomized participants (including censored) who received at least one dose of study drug and had non-missing Symptom Resolution values. Censored participants = 7.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2/3: Time to Complete Symptom Resolution [Arm 22] | 5.00 days |
Secondary
Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22]
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Time frame: Baseline through Day 29
Population: Phase 2/3: All randomized participants (Including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored participants = 34.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22] | 11.00 days |
Secondary
Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22]
Sustained complete symptom resolution is defined as the first of 2 consecutive days with complete symptom resolution.
Time frame: Baseline through Day 29
Population: Phase 2/3: All randomized participants (including censored) who received at least one dose of study drug and had non-missing Symptom Resolution values. Censored participants = 13.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22] | 7.00 days |
Secondary
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.
Time frame: Baseline, Day 11
Population: Phase 2: All randomized participants who received at least one dose of study drug and had baseline and post-baseline viral load value. Participants enrolled with recent symptoms prior to randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization | -4.03 unitless | Standard Error 0.155 |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization | -3.87 unitless | Standard Error 0.187 |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization | -4.20 unitless | Standard Error 0.184 |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization | -3.65 unitless | Standard Error 0.191 |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization | -4.46 unitless | Standard Error 0.178 |
p-value: 0.49995% CI: [-0.31, 0.64]Mixed Models Analysis
p-value: 0.49295% CI: [-0.64, 0.31]Mixed Models Analysis
p-value: 0.12595% CI: [-0.11, 0.86]Mixed Models Analysis
p-value: 0.06995% CI: [-0.89, 0.03]Mixed Models Analysis
Secondary
Phase 2: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Time frame: Day 11
Population: Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Improvement | 43.4 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Improvement | 59.4 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Improvement | 44.9 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Improvement | 58.4 percentage of participants |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Improvement | 53.2 percentage of participants |
p-value: 0.01495% CI: [1.14, 3.15]Regression, Logistic
p-value: 0.82895% CI: [0.64, 1.74]Regression, Logistic
p-value: 0.02295% CI: [1.09, 3.02]Regression, Logistic
p-value: 0.11995% CI: [0.9, 2.43]Regression, Logistic
Secondary
Phase 2: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise. Missing data were imputed using non-responder imputation (NRI) method.
Time frame: Day 11
Population: Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Resolution | 36.8 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Resolution | 50.5 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Resolution | 40.2 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Resolution | 43.6 percentage of participants |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Demonstrating Symptom Resolution | 45.9 percentage of participants |
p-value: 0.03495% CI: [1.04, 2.9]Regression, Logistic
p-value: 0.59495% CI: [0.69, 1.91]Regression, Logistic
p-value: 0.29195% CI: [0.79, 2.2]Regression, Logistic
p-value: 0.14395% CI: [0.88, 2.4]Regression, Logistic
Secondary
Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
Time frame: Baseline through Day 85
Population: Phase 2: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 5.8 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 1.0 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 1.9 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 2.0 percentage of participants |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 0.9 percentage of participants |
p-value: 0.09895% CI: [0.04, 1.31]Regression, Logistic
p-value: 0.16595% CI: [0.09, 1.51]Regression, Logistic
p-value: 0.19195% CI: [0.1, 1.6]Regression, Logistic
p-value: 0.07595% CI: [0.04, 1.18]Regression, Logistic
Secondary
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
Time frame: Day 29 Post-dose
Population: Phase 2: All randomized participants who received a complete dose of Bamlanivimab (for Bamlanivimab only arms) or Bamlanivimab in the Presence of Etesevimab (for Bamlanivimab + Etesevimab) and had at least 1 post-dose PK sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab | 25.6 Microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 42.2 |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab | 83.8 Microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 50 |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab | 227 Microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 39.6 |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab | 100 Microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 46.1 |
Secondary
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Time frame: Day 29 Post-dose
Population: Phase 2: All randomized participants who received a complete dose of Etesevimab in the Presence of Bamlanivimab and had at least 1 post-dose PK sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab | 243 µg/mL | Geometric Coefficient of Variation 35.1 |
Secondary
Phase 2: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Time frame: Baseline through Day 29
Population: Phase 2: All randomized participants (including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored: Part A: Placebo= 68, Phase 2: 700 mg Bamlanivimab=39, Phase 2: 2800 mg Bamlanivimab=40, Phase 2: 7000 mg Bamlanivimab=42 and Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab=45
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Time to SARS-CoV-2 Viral Clearance | 24 Days |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Time to SARS-CoV-2 Viral Clearance | 25.00 Days |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Time to SARS-CoV-2 Viral Clearance | 23.00 Days |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 2: Time to SARS-CoV-2 Viral Clearance | 25.00 Days |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 2: Time to SARS-CoV-2 Viral Clearance | 21.00 Days |
p-value: 0.616Stratified Log-rank
p-value: 0.281Stratified Log-rank
p-value: 0.815Stratified Log-rank
p-value: 0.334Stratified Log-rank
Secondary
Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral and is unitless.
Time frame: Baseline, Day 7
Population: Phase 3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -2.46 unitless | Standard Error 0.095 |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.66 unitless | Standard Error 0.09 |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -2.56 unitless | Standard Error 0.079 |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.65 unitless | Standard Error 0.098 |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -2.51 unitless | Standard Error 0.185 |
| Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.50 unitless | Standard Error 0.147 |
p-value: <095% CI: [-1.46, -0.94]Mixed Models Analysis
p-value: <095% CI: [-1.34, -0.85]Mixed Models Analysis
p-value: 0.0000377795% CI: [-1.45, -0.52]Mixed Models Analysis
Secondary
Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Time frame: Day 11
Population: Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Improvement | 40.9 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Improvement | 51.0 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Improvement | 40.1 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Improvement | 52.7 percentage of participants |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Improvement | 38.3 percentage of participants |
| Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Improvement | 54.0 percentage of participants |
95% CI: [1.17, 1.93]
95% CI: [1.33, 2.09]
95% CI: [1.22, 2.9]
Secondary
Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
Time frame: Day 11
Population: Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Resolution | 52.1 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Resolution | 61.2 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Resolution | 50.9 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Resolution | 61.8 percentage of participants |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Resolution | 51.8 percentage of participants |
| Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: Percentage of Participants Demonstrating Symptom Resolution | 63.8 percentage of participants |
95% CI: [1.13, 1.86]
95% CI: [1.24, 1.95]
95% CI: [1.06, 2.53]
Secondary
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.
Time frame: Baseline through Day 85
Population: Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 7.2 percentage of participants |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 2.5 percentage of participants |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 7.0 percentage of participants |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 1.2 percentage of participants |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 4.3 percentage of participants |
| Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | 0.9 percentage of participants |
95% CI: [0.18, 0.64]
95% CI: [0.07, 0.38]
95% CI: [0.06, 1.05]
Secondary
Phase 3: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Time frame: Baseline through Day 29
Population: Phase 3: All randomized participants (Including censored) who received at least 1 dose of study drug and had at least 1 post-baseline viral load measurement. Censored participants: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 358, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 325, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab =530, 700 mg Bamlanivimab + 1400 mg Etesevimab= 326, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=95, 350 mg Bamlanivimab + 700 mg Etesevimab=114
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Time to SARS-CoV-2 Viral Clearance | NA Days |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Time to SARS-CoV-2 Viral Clearance | NA Days |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Time to SARS-CoV-2 Viral Clearance | NA Days |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Time to SARS-CoV-2 Viral Clearance | NA Days |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Time to SARS-CoV-2 Viral Clearance | NA Days |
| Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: Time to SARS-CoV-2 Viral Clearance | NA Days |
p-value: 0.007Stratified Log-rank
p-value: 0.033Stratified Log-rank
p-value: 0.017Stratified Log-rank
Secondary
Phase 3: Time to Sustained Symptom Resolution
Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.
Time frame: Baseline through Day 29
Population: Phase 3: All randomized participants (including censored) who received at least one dose of study drug and who had at least one post-baseline symptom measurement. Participants censored: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 121, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 88, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab= 226, 700 mg Bamlanivimab + 1400 mg Etesevimab= 128, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=44, 350 mg Bamlanivimab + 700 mg Etesevimab=43
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Time to Sustained Symptom Resolution | 9.00 Days |
| Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Time to Sustained Symptom Resolution | 8.00 Days |
| Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Time to Sustained Symptom Resolution | 9.00 Days |
| Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab | Phase 3: Time to Sustained Symptom Resolution | 8.00 Days |
| Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab | Phase 3: Time to Sustained Symptom Resolution | 9.00 Days |
| Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab | Phase 3: Time to Sustained Symptom Resolution | 6.00 Days |
p-value: 0.007Stratified Log-rank
p-value: 0.13Stratified Log-rank
p-value: 0.012Stratified Log-rank