Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I7W-MC-UDAA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Trial terminated for futility.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3127804 | Experimental | Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15. |
|
| Placebo | Placebo Comparator | Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3127804 | Drug | Administered IV |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator Free Days | Ventilator-free days were defined as the number of days from Day 1 through Day 28 on which a participant breathed without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours and the participant did not die within 28 days from the first dose of the study drug. | Day 1 through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale | The NIAID ordinal scale clinical status was defined as the lowest score achieved for that day, the lowest NIAID score from Day 1 through Day 28 for each participant was reported. NIAID ordinal assessment levels are reported by using the following 8 point scale, where a higher score is a better outcome: 1) death, 2) hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), 3) hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4) hospitalized, requiring supplemental oxygen, 5) hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19-related or otherwise), 6) hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care, 7) not hospitalized, limitation on activities and/or requiring home oxygen, and, 8) not hospitalized, no limitations on activities. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Banner Univ Med Ctr Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Banner Univ Med Ctr Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35991210 | Derived | Jones RS, Smith PS, Berg PH, de la Pena A, Cook PP, Shawa I, Kioussopoulos KM, Hu Y, Schott RJ. Efficacy and Safety of LY3127804, an Anti-Angiopoietin-2 Antibody, in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients Hospitalized with Pneumonia and Presumed or Confirmed COVID-19. Clin Med Insights Circ Respir Pulm Med. 2022 Aug 10;16:11795484221119316. doi: 10.1177/11795484221119316. eCollection 2022. |
| Label | URL |
|---|---|
| A Study of LY3127804 in Participants With COVID-19 | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LY3127804 | Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15. |
| FG001 | Placebo | Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY3127804 | Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15. |
| BG001 | Placebo | Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15. |
| 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 | Ventilator Free Days | Ventilator-free days were defined as the number of days from Day 1 through Day 28 on which a participant breathed without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours and the participant did not die within 28 days from the first dose of the study drug. | All randomized participants who received at least 1 dose of study drug. | Posted | Median | Full Range | days | Day 1 through Day 28 |
|
Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY3127804 | Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
The study was terminated for futility reason.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2020 | Jul 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2021 | Jul 27, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D045169 | Severe Acute Respiratory Syndrome |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711748 | zansecimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered IV |
|
| Day 1 through Day 28 |
| Percentage of Participants With Complete Response | Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28. | Day 1 through Day 28 |
| Number of Participants Who Died Between Day 1 Through Day 28 | Day 1 through Day 28 |
| Length of Hospitalization | Days of participants hospitalization. | Day 1 through Day 28 |
| Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE) | An SAE is any AE from this study that results in one of the following outcomes: death that is not related to COVID-19 or a sequela of COVID-19 or death that is considered by the investigator to be related to study drug, prolonged inpatient hospitalization or re-hospitalization life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other SAE outcomes. | Day 1 through Day 60 |
| Number of Participants With Any Treatment Emergent Adverse Event (TEAE) | TEAE was defined as any untoward medical occurrence that emerges during a defined treatment period, having been absent pre-treatment, or worsens relative to the pretreatment state, and does not necessarily had a causal relationship with the study treatment. | Day 1 through Day 60 |
| Tucson |
| Arizona |
| 85719 |
| United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| Nuvance Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Henry Ford Hospital Detroit | Detroit | Michigan | 48202-2689 | United States |
| Allina Hospital Network | Minneapolis | Minnesota | 55404 | United States |
| State University of New York Hospital | Syracuse | New York | 13210 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Withdrawal by Subject |
|
| BG002 | 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 |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
|
|
| Secondary | Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale | The NIAID ordinal scale clinical status was defined as the lowest score achieved for that day, the lowest NIAID score from Day 1 through Day 28 for each participant was reported. NIAID ordinal assessment levels are reported by using the following 8 point scale, where a higher score is a better outcome: 1) death, 2) hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), 3) hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4) hospitalized, requiring supplemental oxygen, 5) hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19-related or otherwise), 6) hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care, 7) not hospitalized, limitation on activities and/or requiring home oxygen, and, 8) not hospitalized, no limitations on activities. | All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Day 1 through Day 28 |
|
|
|
| Secondary | Percentage of Participants With Complete Response | Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 through Day 28 |
|
|
|
| Secondary | Number of Participants Who Died Between Day 1 Through Day 28 | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Day 1 through Day 28 |
|
|
|
| Secondary | Length of Hospitalization | Days of participants hospitalization. | All randomized participants who received at least 1 dose of study drug. | Posted | Median | Inter-Quartile Range | days | Day 1 through Day 28 |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE) | An SAE is any AE from this study that results in one of the following outcomes: death that is not related to COVID-19 or a sequela of COVID-19 or death that is considered by the investigator to be related to study drug, prolonged inpatient hospitalization or re-hospitalization life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other SAE outcomes. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Day 1 through Day 60 |
|
|
|
| Secondary | Number of Participants With Any Treatment Emergent Adverse Event (TEAE) | TEAE was defined as any untoward medical occurrence that emerges during a defined treatment period, having been absent pre-treatment, or worsens relative to the pretreatment state, and does not necessarily had a causal relationship with the study treatment. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Day 1 through Day 60 |
|
|
|
| 8 |
| 47 |
| 6 |
| 47 |
| 30 |
| 47 |
| EG001 | Placebo | Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15. | 6 | 48 | 2 | 48 | 31 | 48 |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory failure | 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 |
|
Not provided
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
| NIAID Level 3 |
|
| NIAID Level 4 |
|
| NIAID Level 5 |
|
| NIAID Level 6 |
|
| NIAID Level 7 |
|
| NIAID Level 8 |
|