A Study of LY3127804 in Participants With COVID-19

Study Overview
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Brief Summary
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A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19

Conditions
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COVID-19, Pneumonia

Intervention / Treatment
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* Drug: LY3127804
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are hospitalized with pneumonia, and presumed or confirmed COVID-19 Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed) Exclusion Criteria: Female participants must not be pregnant and/or lactating Have Acute Respiratory Distress Syndrome (ARDS) or will require immediate intermittent mandatory ventilation (IMV), or are ineligible for IMV Have any concurrent serious medical condition (for example dialysis) or concomitant medication that would preclude participation in the study Are moribund irrespective of the provision of treatments Have a known history or show evidence of human immunodeficiency virus (HIV) and/or hepatitis Have recently undergone major surgery or central venous access device placement Have a significant bleeding disorder or active vasculitis Have experienced a thromboembolic event Have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia Have a serious, nonhealing wound, peptic ulcer, or bone fracture Have liver cirrhosis Have a known sensitivity to monoclonal antibodies (mAbs) or other therapeutic proteins Have a history of hypertensive crisis or hypertensive encephalopathy or current, poorly controlled hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3127804<br>Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15. | Drug: LY3127804<br>* Administered IV<br>|
| Placebo Comparator: Placebo<br>Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15. | Drug: Placebo<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corona Virus Disease 19 (COVID-19), 2019 Novel Coronavirus (2019 n-COV), Severe Acute Respiratory Syndrome (SARS), Pulmonary Disease, SARS-CoV-2