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| ID | Type | Description | Link |
|---|---|---|---|
| J2W-MC-PYAA | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| AbCellera Biologics Inc. | INDUSTRY |
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The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3819253 | Experimental | Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion. |
|
| Placebo | Placebo Comparator | Participants received single dose of Placebo as intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3819253 | Drug | Administered IV. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. | Baseline through Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29. | Day 29 |
| Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Veterans Affairs Medical Center San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35713300 | Derived | 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. | |
| 34473343 |
| Label | URL |
|---|---|
| A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received single dose of Placebo as intravenous infusion. |
| FG001 | 700 mg LY3819253 IV | Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion. |
| FG002 | 2800 mg LY3819253 IV | Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion. |
| FG003 | 7000 mg LY3819253 IV | Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received single dose of Placebo as intravenous infusion. |
| BG001 | 700 mg LY3819253 IV | Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. | All randomized participants who received at least one dose of study drug. | Posted | Number | Participants | Baseline through Day 60 |
|
Baseline through day 60
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received single dose of Placebo as intravenous infusion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2020 | Mar 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2020 | Mar 10, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711749 | bamlanivimab |
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| Placebo | Drug | Administered IV. |
|
Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.
| Baseline, Day 29 |
| Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | The SARS-CoV-2 viral load was derived from the cycle time (CT) values using a polymerase chain reaction (PCR) assay. Higher CT values indicate a lower viral load. | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose |
| Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | Pharmacodynamics (PD): Time to SARS-CoV-2 clearance. | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose |
| San Diego |
| California |
| 92161 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | United States |
| Alexandria Center for Life - NYC/ NYCEDC | New York | New York | 10016 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Unified Research Enterprise Brody School of Medicine at ECU | Greenville | North Carolina | 27834 | United States |
| Temple Univ School of Med | Philadelphia | Pennsylvania | 19140 | United States |
| 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. |
| 34374951 | Derived | 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. |
| Lost to Follow-up |
|
| BG002 | 2800 mg LY3819253 IV | Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion. |
| BG003 | 7000 mg LY3819253 IV | Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | 700 mg LY3819253 IV | Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion. |
| OG002 | 2800 mg LY3819253 IV | Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion. |
| OG003 | 7000 mg LY3819253 IV | Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion. |
|
|
| Secondary | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Day 29 |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load | Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load. | All randomized participants who received at least one dose of study drug and had baseline, post baseline data for viral load. | Posted | Mean | Standard Deviation | log10 (Copies/mL) | Baseline, Day 29 |
|
|
|
| Secondary | Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | The SARS-CoV-2 viral load was derived from the cycle time (CT) values using a polymerase chain reaction (PCR) assay. Higher CT values indicate a lower viral load. | All randomized participants who received at least one dose of study drug and had data for SARS-CoV-2 viral load AUC. | Posted | Mean | Standard Deviation | Cycles*day | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose |
|
|
|
| Secondary | Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | Pharmacodynamics (PD): Time to SARS-CoV-2 clearance. | All randomized participants who received at least one dose of study drug and had data for SARS-CoV-2 clearance. | Posted | Mean | Standard Deviation | Days | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | 700 mg LY3819253 IV | Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | 2800 mg LY3819253 IV | Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | 7000 mg LY3819253 IV | Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion. | 0 | 6 | 0 | 6 | 2 | 6 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |