Trial record 1 of 1 for: NCT04497987

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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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

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
Arm/Group Description	Participants received single IV inf...	Participants received single IV inf...
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

Baseline Characteristics

Arm/Group Title		Placebo	4200 mg Bamlanivimab	Total
Arm/Group Description		Participants received single IV inf...	Participants received single IV inf...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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
United States		587	588	1175

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With COVID-19
Description	The endpoint for the primary analysis is defined as the first occurren...
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

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.


Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description:	Participants received single IV inf...	Participants received single IV inf...
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)

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
Description	The endpoint defined as the detection of SARS-CoV-2 by polymerase chai...
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

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.


Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description:	Participants received single IV inf...	Participants received single IV inf...
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)

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
Description	Percentage of Participants with SARS-CoV-2.
Description	Percentage of Participants with SARS-CoV-2.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.


Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description:	Participants received single IV inf...	Participants received single IV inf...
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)

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
Description	Percentage of Participants Who are Hospitalized or Have Died due to CO...
Description	Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.


Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description:	Participants received single IV inf...	Participants received single IV inf...
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
Description	Percentage of Participants who Experience COVID-19-Related Hospitaliza...
Description	Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.


Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description:	Participants received single IV inf...	Participants received single IV inf...
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
Description	Percentage of Participants Who Die Due to COVID-19.
Description	Percentage of Participants Who Die Due to COVID-19.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.


Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description:	Participants received single IV inf...	Participants received single IV inf...
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
Description	Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered...
Description	Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Time Frame	Day 29, 57, 85, 141 and 169

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data.


Arm/Group Title		4200mg Bamlanivimab
Arm/Group Description:		Participants received single IV inf...
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
Day 29		162 (44.4%)
Day 57	Number Analyzed	536 participants
Day 57		61.8 (59.9%)
Day 85	Number Analyzed	369 participants
Day 85		28.4 (61.6%)
Day 141	Number Analyzed	137 participants
Day 141		17.5 (46.2%)
Day 169	Number Analyzed	49 participants
Day 169		15.1 (42.3%)

Adverse Events

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
Arm/Group Description	Participants received single IV inf...		Participants received single IV inf...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

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Name/Title:	Chief Medical Officer
Organization:	Eli Lilly and Company
Phone:	800-545-5979
EMail:	ClinicalTrials.gov@lilly.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.

Cohen MS, Nirula A, Mulligan MJ, Novak RM, Marovich M, Yen C, Stemer A, Mayer SM, Wohl D, Brengle B, Montague BT, Frank I, McCulloh RJ, Fichtenbaum CJ, Lipson B, Gabra N, Ramirez JA, Thai C, Chege W, Gomez Lorenzo MM, Sista N, Farrior J, Clement ME, Brown ER, Custer KL, Van Naarden J, Adams AC, Schade AE, Dabora MC, Knorr J, Price KL, Sabo J, Tuttle JL, Klekotka P, Shen L, Skovronsky DM; BLAZE-2 Investigators. Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):46-55. doi: 10.1001/jama.2021.8828.

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

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