Trial Outcomes & Findings for A Study of LY3127804 in Participants With COVID-19 (NCT NCT04342897)
NCT ID: NCT04342897
Last Updated: 2021-08-12
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Day 1 through Day 28
Results posted on
2021-08-12
Participant Flow
Participant milestones
| Measure |
LY3127804
Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
|
Placebo
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
Received at Least One Dose of Study Drug
|
47
|
48
|
|
Overall Study
COMPLETED
|
33
|
36
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
| Measure |
LY3127804
Participants received 20 milligrams (mg) per kilogram (kg) of LY3127804 as an intravenous (IV) infusion on Days 1 and 15.
|
Placebo
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Overall Study
Death
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
A Study of LY3127804 in Participants With COVID-19
Baseline characteristics by cohort
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 Years
STANDARD_DEVIATION 14.13 • n=5 Participants
|
55.5 Years
STANDARD_DEVIATION 14.40 • n=7 Participants
|
54.9 Years
STANDARD_DEVIATION 14.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
33.74 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.963 • n=5 Participants
|
33.70 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 7.715 • n=7 Participants
|
33.72 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 7.314 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Ventilator Free Days
|
28 days
Interval 12.0 to 28.0
|
28 days
Interval 4.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 4
|
24 Participants
|
19 Participants
|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 1
|
7 Participants
|
4 Participants
|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 2
|
3 Participants
|
2 Participants
|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 3
|
12 Participants
|
21 Participants
|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 5
|
1 Participants
|
2 Participants
|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 6
|
0 Participants
|
0 Participants
|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 7
|
0 Participants
|
0 Participants
|
|
Number of Participants Reported Lowest Score on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
NIAID Level 8
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants who received at least 1 dose of study drug.
Complete response was defined as being alive and never requiring mechanical ventilator support (at any point while on study) through Day 28.
Outcome measures
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Percentage of Participants With Complete Response
|
78.7 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Number of Participants Who Died Between Day 1 Through Day 28
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants who received at least 1 dose of study drug.
Days of participants hospitalization.
Outcome measures
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Length of Hospitalization
|
6 days
Interval 4.0 to 12.0
|
6 days
Interval 5.0 to 13.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: All randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: All randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
LY3127804
n=47 Participants
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 Participants
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
|
33 participants
|
31 participants
|
Adverse Events
LY3127804
Serious events: 6 serious events
Other events: 30 other events
Deaths: 8 deaths
Placebo
Serious events: 2 serious events
Other events: 31 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
LY3127804
n=47 participants at risk
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 participants at risk
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
2/47 • Number of events 2 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/47 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
1/47 • Number of events 2 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
LY3127804
n=47 participants at risk
Participants received 20 mg/kg of LY3127804 as an IV infusion on Days 1 and 15.
|
Placebo
n=48 participants at risk
Participants received 20 mg/kg of Placebo as an IV infusion on Days 1 and 15.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.6%
5/47 • Number of events 5 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
12.8%
6/47 • Number of events 6 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
14.6%
7/48 • Number of events 7 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
4.2%
2/48 • Number of events 2 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
4.2%
2/48 • Number of events 2 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.1%
1/47 • Number of events 1 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
5/47 • Number of events 6 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
4.2%
2/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.5%
4/47 • Number of events 4 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
12.5%
6/48 • Number of events 6 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
10.6%
5/47 • Number of events 5 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
8.3%
4/48 • Number of events 6 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Number of events 2 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.4%
3/47 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.5%
4/47 • Number of events 4 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
10.4%
5/48 • Number of events 5 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
8.5%
4/47 • Number of events 5 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 3 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
6.4%
3/47 • Number of events 4 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Number of events 4 • Day 1 through Day 60
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60