Phase 3
Completed N=2,849
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness
Source: ClinicalTrials.gov NCT04427501 ↗Enrolled (actual)
2,849
Serious AEs
1.5%
Results posted
Mar 2022
Primary outcomePrimary: 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; 2.1; 6.8; 0.8 percentage of participants
◆ Published Evidence
Established
68citations · ~17 / year
A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load.
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.
Linked Publications (5)
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A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load.
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SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19.
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Bamlanivimab and Etesevimab Improve Symptoms and Associated Outcomes in Ambulatory Patients at Increased Risk for Severe Coronavirus Disease 2019: Results From the Placebo-Controlled Double-Blind Phase 3 BLAZE-1 Trial.
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Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19.
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Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
7.0; 2.1; 6.8; 0.8 | — |
| 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 |
34.8; 10.8 | — |
| PRIMARY Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load |
-3.80; -3.72; -4.08; -3.49; -4.37 | 0.6921 |
| PRIMARY Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) |
0.6; 0; 0; 0; 0.9 | — |
| PRIMARY Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab) |
29.9; 23.7; 21.2; 40.2 | — |
| PRIMARY Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab) |
140; 129; 122; 193 | — |
| PRIMARY Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23] |
481 | — |
| SECONDARY Phase 3: Percentage of Participants Demonstrating Symptom Resolution |
52.1; 61.2; 50.9; 61.8; 51.8; 63.8 | — |
| SECONDARY Phase 3: Percentage of Participants Demonstrating Symptom Improvement |
40.9; 51.0; 40.1; 52.7; 38.3; 54.0 | — |
| SECONDARY Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause |
7.2; 2.5; 7.0; 1.2; 4.3; 0.9 | — |
| SECONDARY Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load |
-2.46; -3.66; -2.56; -3.65; -2.51; -3.50 | <0.0000000 sig |
| SECONDARY Phase 3: Time to Sustained Symptom Resolution |
9.00; 8.00; 9.00; 8.00; 9.00; 6.00 | 0.007 sig |
| SECONDARY Phase 3: Time to SARS-CoV-2 Viral Clearance |
NA; NA; NA; NA; NA; NA | 0.007 sig |
| SECONDARY 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; -3.87; -4.20; -3.65; -4.46 | 0.499 |
| SECONDARY Phase 2: Percentage of Participants Demonstrating Symptom Resolution |
36.8; 50.5; 40.2; 43.6; 45.9 | 0.034 sig |
| SECONDARY Phase 2: Percentage of Participants Demonstrating Symptom Improvement |
43.4; 59.4; 44.9; 58.4; 53.2 | 0.014 sig |
| SECONDARY Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab |
25.6; 83.8; 227; 100 | — |
| SECONDARY Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab |
243 | — |
| SECONDARY Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause |
5.8; 1.0; 1.9; 2.0; 0.9 | 0.098 |
| SECONDARY Phase 2: Time to SARS-CoV-2 Viral Clearance |
24; 25.00; 23.00; 25.00; 21.00 | 0.616 |
| 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] |
— | — |
| SECONDARY 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 | — |
| SECONDARY Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22] |
10.9 | — |
| SECONDARY Phase 2/3: Time to Complete Symptom Resolution [Arm 22] |
5.00 | — |
| SECONDARY Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22] |
7.00 | — |
| SECONDARY Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22] |
11.00 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04427501) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.