A Study of LY3127804 in Participants With COVID-19

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04342897

Enrollment

Registered

2020-04-13

Start date

2020-04-20

Completion date

2020-10-12

Last updated

2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Pneumonia

Keywords

Corona Virus Disease 19 (COVID-19), 2019 Novel Coronavirus (2019 n-COV), Severe Acute Respiratory Syndrome (SARS), Pulmonary Disease, SARS-CoV-2

Brief summary

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

Interventions

DRUGLY3127804

Administered IV

DRUGPlacebo

Administered IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ventilator Free Days	Day 1 through Day 28	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.

Secondary

Measure	Time frame	Description
Percentage of Participants With Complete Response	Day 1 through Day 28	Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28.
Number of Participants Who Died Between Day 1 Through Day 28	Day 1 through Day 28	—
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale	Day 1 through Day 28	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.
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)	Day 1 through Day 60	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.
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)	Day 1 through Day 60	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.
Length of Hospitalization	Day 1 through Day 28	Days of participants hospitalization.

Countries

United States

Participant flow

Participants by arm

Arm	Count
LY3127804 Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.	47
Placebo Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.	48
Total	95

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	7	4
Overall Study	Lost to Follow-up	6	6
Overall Study	Withdrawal by Subject	1	2

Baseline characteristics

Characteristic	LY3127804	Placebo	Total
Age, Continuous	54.3 Years STANDARD_DEVIATION 14.13	55.5 Years STANDARD_DEVIATION 14.4	54.9 Years STANDARD_DEVIATION 14.2
Body Mass Index (BMI)	33.74 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.963	33.70 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 7.715	33.72 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 7.314
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants	20 Participants	43 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants	28 Participants	52 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) Black or African American	8 Participants	7 Participants	15 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	36 Participants	38 Participants	74 Participants
Region of Enrollment United States	47 Participants	48 Participants	95 Participants
Sex: Female, Male Female	18 Participants	17 Participants	35 Participants
Sex: Female, Male Male	29 Participants	31 Participants	60 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	8 / 47	6 / 48
other Total, other adverse events	30 / 47	31 / 48
serious Total, serious adverse events	6 / 47	2 / 48

Outcome results

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.

Time frame: Day 1 through Day 28