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A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2)

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ClinicalTrials.gov Identifier: NCT04497987
Recruitment Status : Completed
First Posted : August 4, 2020
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions COVID-19
SARS-CoV2
Interventions Drug: Bamlanivimab
Drug: Placebo
Drug: Etesevimab
Enrollment 1180
Recruitment Details This trial was planned as a 3-part study. Part 1 was to evaluate the efficacy and safety of bamlanivimab (BAM) in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19), compared with Placebo (PBO). Part 2 was to demonstrate superior efficacy of BAM and BAM + ETE over PBO in the prevention of COVID-19. Part 3 was exploratory cohort.
Pre-assignment Details Enrollment for Part 2 was not initiated because the efficacy of BAM 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
Arm/Group Title Placebo 4200 mg Bamlanivimab
Hide Arm/Group Description Participants received single IV infusion of Placebo. Participants received single IV infusion of 4200 milligrams (mg) bamlanivimab.
Period Title: Overall Study
Started 592 588
Received at Least One Dose of Study Drug 587 588
Prevention Population 485 487
Treatment Population 68 66
Serology Positive 36 35
Completed 493 521
Not Completed 99 67
Reason Not Completed
Adverse Event             1             0
Death             21             13
Lost to Follow-up             19             17
Other - as reported by the investigator             22             16
Physician Decision             1             0
Withdrawal by Subject             35             21
Arm/Group Title Placebo 4200 mg Bamlanivimab Total
Hide Arm/Group Description Participants received single IV infusion of Placebo. Participants received single IV infusion of 4200 mg bamlanivimab. Total of all reporting groups
Overall Number of Baseline Participants 587 588 1175
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 587 participants 588 participants 1175 participants
52.2  (20.3) 53.4  (20.7) 52.8  (20.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 588 participants 1175 participants
Female 443 434 877
Male 144 154 298
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 588 participants 1175 participants
Hispanic or Latino 36 26 62
Not Hispanic or Latino 551 561 1112
Unknown or Not Reported 0 1 1
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 588 participants 1175 participants
American Indian or Alaska Native 1 4 5
Asian 8 6 14
Native Hawaiian or Other Pacific Islander 3 2 5
Black or African American 52 48 100
White 515 519 1034
More than one race 3 5 8
Unknown or Not Reported 5 4 9
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 587 participants 588 participants 1175 participants
587 588 1175
1.Primary Outcome
Title Percentage of Participants With COVID-19
Hide Description The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Time Frame Week 8 after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from prevention population.
Arm/Group Title Placebo 4200mg Bamlanivimab
Hide Arm/Group Description:
Participants received single IV infusion of Placebo.
Participants received single IV infusion of 4200mg bamlanivimab.
Overall Number of Participants Analyzed 485 487
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
15.7
(12.5 to 18.9)
8.3
(5.8 to 10.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 4200mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.26 to 0.63
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Moderate or Worse Severity COVID-19
Hide Description The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Time Frame Week 8 after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from prevention population.
Arm/Group Title Placebo 4200mg Bamlanivimab
Hide Arm/Group Description:
Participants received single IV infusion of Placebo.
Participants received single IV infusion of 4200mg bamlanivimab.
Overall Number of Participants Analyzed 485 487
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
14.7
(11.5 to 17.8)
8.1
(5.6 to 10.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 4200mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.27 to 0.67
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With SARS-CoV-2
Hide Description Percentage of Participants with SARS-CoV-2.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from prevention population.
Arm/Group Title Placebo 4200mg Bamlanivimab
Hide Arm/Group Description:
Participants received single IV infusion of Placebo.
Participants received single IV infusion of 4200mg bamlanivimab.
Overall Number of Participants Analyzed 485 487
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
23.1
(19.4 to 26.9)
17.8
(14.4 to 21.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 4200mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.46 to 0.94
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
Hide Description Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from prevention population.
Arm/Group Title Placebo 4200mg Bamlanivimab
Hide Arm/Group Description:
Participants received single IV infusion of Placebo.
Participants received single IV infusion of 4200mg bamlanivimab.
Overall Number of Participants Analyzed 485 487
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.4
(0.4 to 2.5)
0.4
(0 to 1.0)
5.Secondary Outcome
Title Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
Hide Description Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from prevention population.
Arm/Group Title Placebo 4200mg Bamlanivimab
Hide Arm/Group Description:
Participants received single IV infusion of Placebo.
Participants received single IV infusion of 4200mg bamlanivimab.
Overall Number of Participants Analyzed 485 487
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.4
(0.4 to 2.5)
0.6
(0 to 1.3)
6.Secondary Outcome
Title Percentage of Participants Who Die Due to COVID-19
Hide Description Percentage of Participants Who Die Due to COVID-19.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from prevention population.
Arm/Group Title Placebo 4200mg Bamlanivimab
Hide Arm/Group Description:
Participants received single IV infusion of Placebo.
Participants received single IV infusion of 4200mg bamlanivimab.
Overall Number of Participants Analyzed 485 487
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.8
(0 to 1.6)
0
(0 to 0)
7.Secondary Outcome
Title Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Hide Description Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Time Frame Day 29, 57, 85, 141 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data.
Arm/Group Title 4200mg Bamlanivimab
Hide Arm/Group Description:
Participants received single IV infusion of 4200mg bamlanivimab.
Overall Number of Participants Analyzed 557
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram per milliliter (µg/mL)
Day 29 Number Analyzed 557 participants
162
(44.4%)
Day 57 Number Analyzed 536 participants
61.8
(59.9%)
Day 85 Number Analyzed 369 participants
28.4
(61.6%)
Day 141 Number Analyzed 137 participants
17.5
(46.2%)
Day 169 Number Analyzed 49 participants
15.1
(42.3%)
Time Frame Baseline, up to 9 Months
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
 
Arm/Group Title Placebo 4200mg Bamlanivimab
Hide Arm/Group Description Participants received single IV infusion of Placebo. Participants received single IV infusion of 4200mg bamlanivimab.
All-Cause Mortality
Placebo 4200mg Bamlanivimab
Affected / at Risk (%) Affected / at Risk (%)
Total   21/587 (3.58%)      13/588 (2.21%)    
Hide Serious Adverse Events
Placebo 4200mg Bamlanivimab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/587 (5.11%)      39/588 (6.63%)    
Blood and lymphatic system disorders     
Anaemia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Iron deficiency anaemia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Thrombocytopenia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Cardiac disorders     
Acute myocardial infarction  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Atrial fibrillation  1  0/587 (0.00%)  0 3/588 (0.51%)  3
Cardiac failure  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Cardiac failure acute  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Cardiac failure congestive  1  2/587 (0.34%)  3 2/588 (0.34%)  2
Cardio-respiratory arrest  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Cardiomyopathy  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Coronary artery disease  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Myocardial infarction  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Endocrine disorders     
Thyrotoxic crisis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Abdominal pain upper  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Ascites  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Gastrointestinal haemorrhage  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Mouth haemorrhage  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Oesophageal ulcer  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Small intestinal obstruction  1  0/587 (0.00%)  0 1/588 (0.17%)  1
General disorders     
Death  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Gait disturbance  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Sudden death  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Hepatic cirrhosis  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Infections and infestations     
Acquired immunodeficiency syndrome  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Bacteraemia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Clostridium difficile infection  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Escherichia bacteraemia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Escherichia urinary tract infection  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Gastroenteritis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Groin abscess  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Osteomyelitis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Pneumonia  1  2/587 (0.34%)  2 2/588 (0.34%)  2
Pyelonephritis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Sepsis  1  3/587 (0.51%)  3 3/588 (0.51%)  3
Septic shock  1  1/587 (0.17%)  1 2/588 (0.34%)  2
Upper respiratory tract infection  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Urinary tract infection  1  0/587 (0.00%)  0 5/588 (0.85%)  6
Injury, poisoning and procedural complications     
Fall  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Femur fracture  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hip fracture  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Injury corneal  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Limb injury  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Multiple injuries  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Open globe injury  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Road traffic accident  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Spinal compression fracture  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Investigations     
Blood creatinine increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalaemia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hypoglycaemia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Nervous system disorders     
Cerebrovascular accident  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Dementia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Headache  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Hypoaesthesia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Metabolic encephalopathy  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Paraesthesia  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Syncope  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Transient ischaemic attack  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/443 (0.23%)  1 0/434 (0.00%)  0
Psychiatric disorders     
Depression suicidal  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Mental status changes  1  0/587 (0.00%)  0 1/588 (0.17%)  2
Post-traumatic stress disorder  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/587 (0.17%)  1 1/588 (0.17%)  1
End stage renal disease  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Nephrolithiasis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Renal artery stenosis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Ureterolithiasis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Chronic obstructive pulmonary disease  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Epistaxis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hypoxia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Pneumonia aspiration  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Pulmonary mass  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Respiratory failure  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Ingrowing nail  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Vascular disorders     
Hypovolaemic shock  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Lymphoedema  1  0/587 (0.00%)  0 1/588 (0.17%)  1
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 4200mg Bamlanivimab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   147/587 (25.04%)      145/588 (24.66%)    
Blood and lymphatic system disorders     
Anaemia  1  2/587 (0.34%)  2 1/588 (0.17%)  1
Leukocytosis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Thrombocytopenia  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Cardiac disorders     
Angina pectoris  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Atrial thrombosis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Cardiac failure congestive  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Cardiomegaly  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Palpitations  1  0/587 (0.00%)  0 3/588 (0.51%)  3
Sinus bradycardia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Tachycardia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Ventricular fibrillation  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Ear and labyrinth disorders     
Ear pain  1  0/587 (0.00%)  0 2/588 (0.34%)  3
Eustachian tube dysfunction  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Excessive cerumen production  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Tinnitus  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Vertigo  1  1/587 (0.17%)  1 5/588 (0.85%)  5
Endocrine disorders     
Adrenal insufficiency  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Hyperparathyroidism  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Eye disorders     
Eye discharge  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Eye pruritus  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Retinal detachment  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Abdominal hernia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Abdominal pain  1  2/587 (0.34%)  2 2/588 (0.34%)  2
Abdominal pain upper  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Anal incontinence  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Aphthous ulcer  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Constipation  1  3/587 (0.51%)  3 3/588 (0.51%)  3
Dental caries  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Diarrhoea  1  0/587 (0.00%)  0 1/588 (0.17%)  2
Dyspepsia  1  2/587 (0.34%)  2 2/588 (0.34%)  3
Faecaloma  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Gastric disorder  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Gastrooesophageal reflux disease  1  1/587 (0.17%)  1 3/588 (0.51%)  3
Glossodynia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Large intestine polyp  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Mouth ulceration  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Nausea  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Oesophagitis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Oral pain  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Stomatitis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Toothache  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Upper gastrointestinal haemorrhage  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Vomiting  1  0/587 (0.00%)  0 1/588 (0.17%)  1
General disorders     
Asthenia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Chest pain  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Face oedema  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Feeling hot  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Infusion site haemorrhage  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Injection site extravasation  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Non-cardiac chest pain  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Oedema  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Oedema peripheral  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Puncture site haematoma  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Pyrexia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Swelling face  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Hepatobiliary disorders     
Hepatic cirrhosis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hepatic function abnormal  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Immune system disorders     
Food allergy  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Hypersensitivity  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Serum sickness  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Infections and infestations     
Abscess  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Bronchitis  1  3/587 (0.51%)  3 1/588 (0.17%)  1
Candida infection  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Cellulitis  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Clostridium difficile infection  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Conjunctivitis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Cystitis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Device related infection  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Diverticulitis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Ear infection  1  2/587 (0.34%)  2 2/588 (0.34%)  2
Endocarditis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Eye infection  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Fungal infection  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Gastrointestinal bacterial infection  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Kidney infection  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Labyrinthitis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Localised infection  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Nasopharyngitis  1  1/587 (0.17%)  1 2/588 (0.34%)  2
Oral candidiasis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Oral herpes  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Osteomyelitis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Pharyngitis streptococcal  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Pilonidal cyst  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Pneumonia  1  7/587 (1.19%)  7 2/588 (0.34%)  2
Rhinitis  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Sinusitis  1  8/587 (1.36%)  8 2/588 (0.34%)  2
Subcutaneous abscess  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Tooth abscess  1  1/587 (0.17%)  1 3/588 (0.51%)  3
Tooth infection  1  0/587 (0.00%)  0 3/588 (0.51%)  4
Urinary tract infection  1  20/587 (3.41%)  22 11/588 (1.87%)  13
Vaginal infection  1  0/443 (0.00%)  0 1/434 (0.23%)  1
Viral infection  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Injury, poisoning and procedural complications     
Animal bite  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Animal scratch  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Concussion  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Contusion  1  2/587 (0.34%)  2 3/588 (0.51%)  3
Fall  1  9/587 (1.53%)  12 6/588 (1.02%)  6
Foot fracture  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Head injury  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Humerus fracture  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Joint dislocation  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Joint injury  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Ligament sprain  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Limb injury  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Lower limb fracture  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Lumbar vertebral fracture  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Muscle strain  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Rib fracture  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Skin laceration  1  1/587 (0.17%)  1 2/588 (0.34%)  3
Soft tissue injury  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Spinal compression fracture  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Tibia fracture  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Tooth fracture  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Vaccination complication  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Wrist fracture  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Investigations     
Alanine aminotransferase increased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Amylase increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Aspartate aminotransferase increased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Blood albumin decreased  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Blood alkaline phosphatase increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Blood bilirubin increased  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Blood creatinine increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Blood glucose increased  1  2/587 (0.34%)  2 1/588 (0.17%)  1
Blood potassium decreased  1  0/587 (0.00%)  0 1/588 (0.17%)  2
Blood pressure increased  1  1/587 (0.17%)  1 3/588 (0.51%)  3
Blood sodium decreased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Blood urea increased  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Brain natriuretic peptide increased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Breath sounds abnormal  1  0/587 (0.00%)  0 0/588 (0.00%)  0
C-reactive protein increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Capillary nail refill test abnormal  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Gamma-glutamyltransferase increased  1  2/587 (0.34%)  2 1/588 (0.17%)  1
Haemoglobin increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hepatic enzyme increased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
International normalised ratio increased  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Neutrophil count decreased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Neutrophil count increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Procalcitonin increased  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Smear cervix abnormal  1  0/443 (0.00%)  0 1/434 (0.23%)  1
Troponin increased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
White blood cell count decreased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
White blood cell count increased  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  3/587 (0.51%)  4 1/588 (0.17%)  1
Dyslipidaemia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Glucose tolerance impaired  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Gout  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Hypercalcaemia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hyperkalaemia  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Hyperlipidaemia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hyperproteinaemia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Hypoalbuminaemia  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Hypokalaemia  1  2/587 (0.34%)  2 1/588 (0.17%)  1
Metabolic acidosis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Vitamin b complex deficiency  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Vitamin d deficiency  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/587 (0.68%)  4 7/588 (1.19%)  8
Back pain  1  6/587 (1.02%)  6 5/588 (0.85%)  5
Bursitis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Coccydynia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Flank pain  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Inguinal mass  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Intervertebral disc degeneration  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Intervertebral disc protrusion  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Joint effusion  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Joint range of motion decreased  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Joint swelling  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Muscle spasms  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Neck pain  1  2/587 (0.34%)  2 2/588 (0.34%)  2
Osteonecrosis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Pain in extremity  1  3/587 (0.51%)  3 4/588 (0.68%)  4
Sjogren's syndrome  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Spinal stenosis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Trochlear dysplasia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma  1  1/443 (0.23%)  1 0/434 (0.00%)  0
Plasma cell myeloma  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Prostate cancer  1  1/144 (0.69%)  1 0/154 (0.00%)  0
Seborrhoeic keratosis  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Nervous system disorders     
Bell's palsy  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Carpal tunnel syndrome  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Cubital tunnel syndrome  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Dizziness  1  6/587 (1.02%)  6 5/588 (0.85%)  6
Dizziness postural  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Dysgeusia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Headache  1  2/587 (0.34%)  2 2/588 (0.34%)  2
Hypoaesthesia  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Metabolic encephalopathy  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Migraine  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Paraesthesia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Sciatica  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Syncope  1  3/587 (0.51%)  3 1/588 (0.17%)  1
Tremor  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Psychiatric disorders     
Anorgasmia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Anxiety  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Anxiety disorder  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Confusional state  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Delusion  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Depression  1  1/587 (0.17%)  1 3/588 (0.51%)  3
Generalised anxiety disorder  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Insomnia  1  2/587 (0.34%)  2 1/588 (0.17%)  1
Mental status changes  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Bladder spasm  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Dysuria  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Haematuria  1  2/587 (0.34%)  2 0/588 (0.00%)  0
Nephrolithiasis  1  3/587 (0.51%)  3 0/588 (0.00%)  0
Renal failure  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Renal impairment  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Urinary tract obstruction  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Reproductive system and breast disorders     
Breast mass  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Dysmenorrhoea  1  0/443 (0.00%)  0 1/434 (0.23%)  1
Ovarian cyst ruptured  1  1/443 (0.23%)  1 0/434 (0.00%)  0
Vulvovaginal pruritus  1  0/443 (0.00%)  0 1/434 (0.23%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Dysphonia  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Dyspnoea  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Epistaxis  1  2/587 (0.34%)  2 2/588 (0.34%)  2
Haemoptysis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Hypoxia  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Nasal congestion  1  5/587 (0.85%)  5 1/588 (0.17%)  1
Oropharyngeal pain  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Paranasal sinus discomfort  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Pharyngeal paraesthesia  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Pulmonary fibrosis  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Sinus congestion  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Sinus pain  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Sleep apnoea syndrome  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Sneezing  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Wheezing  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Dermatitis allergic  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Dermatitis contact  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Diabetic foot  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Ecchymosis  1  0/587 (0.00%)  0 2/588 (0.34%)  2
Eczema  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Erythema  1  1/587 (0.17%)  1 2/588 (0.34%)  2
Hyperhidrosis  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Night sweats  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Pruritus  1  1/587 (0.17%)  1 2/588 (0.34%)  2
Rash  1  1/587 (0.17%)  1 5/588 (0.85%)  5
Skin exfoliation  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Skin ulcer  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Skin wrinkling  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Stasis dermatitis  1  0/587 (0.00%)  0 0/588 (0.00%)  0
Urticaria  1  1/587 (0.17%)  1 4/588 (0.68%)  4
Surgical and medical procedures     
Dental operation  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Knee arthroplasty  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Retinopexy  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Salpingo-oophorectomy unilateral  1  1/443 (0.23%)  1 0/434 (0.00%)  0
Sinus operation  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Spinal laminectomy  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Tooth extraction  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Vascular disorders     
Aortic arteriosclerosis  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Deep vein thrombosis  1  0/587 (0.00%)  0 1/588 (0.17%)  1
Flushing  1  2/587 (0.34%)  2 2/588 (0.34%)  2
Haematoma  1  1/587 (0.17%)  1 1/588 (0.17%)  1
Hypertension  1  11/587 (1.87%)  11 8/588 (1.36%)  8
Hypotension  1  1/587 (0.17%)  1 0/588 (0.00%)  0
Lymphoedema  1  0/587 (0.00%)  0 1/588 (0.17%)  1
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04497987    
Other Study ID Numbers: 18063
J2X-MC-PYAD ( Other Identifier: Eli Lilly and Company )
CoVPN #3501 ( Other Identifier: National Institute of Allergy and Infectious Diseases (NIAID) )
First Submitted: July 31, 2020
First Posted: August 4, 2020
Results First Submitted: January 11, 2022
Results First Posted: February 4, 2022
Last Update Posted: February 4, 2022