Trial Outcomes & Findings for A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19 (NCT NCT04411628)

Last Updated: 2021-11-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

Baseline through Day 60

Results posted on

2021-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Overall Study STARTED	7	6	7	6
Overall Study Received at Least 1 Dose of Study Drug	6	6	6	6
Overall Study COMPLETED	6	4	5	6
Overall Study NOT COMPLETED	1	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Overall Study Withdrawal by Subject	1	1	2	0
Overall Study Lost to Follow-up	0	1	0	0

Baseline Characteristics

A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV n=6 Participants Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV n=6 Participants Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV n=6 Participants Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.	Total n=24 Participants Total of all reporting groups
Age, Continuous	43.2 Years STANDARD_DEVIATION 8.6 • n=93 Participants	57.2 Years STANDARD_DEVIATION 6.8 • n=4 Participants	48.5 Years STANDARD_DEVIATION 12.1 • n=27 Participants	66.7 Years STANDARD_DEVIATION 6.7 • n=483 Participants	53.9 Years STANDARD_DEVIATION 12.3 • n=36 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	7 Participants n=36 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	5 Participants n=483 Participants	17 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	15 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	9 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants	5 Participants n=483 Participants	19 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Region of Enrollment United States	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	24 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline through Day 60

Population: All randomized participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV n=6 Participants Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV n=6 Participants Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV n=6 Participants Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 29

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV n=5 Participants Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV n=6 Participants Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29	28.2 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 75	59.4 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 37	261 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 50	—

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: All randomized participants who received at least one dose of study drug and had baseline, post baseline data for viral load.

Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV n=4 Participants Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV n=5 Participants Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV n=5 Participants Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load	10.476 log10 (Copies/mL) Standard Deviation 7.117	10.923 log10 (Copies/mL) Standard Deviation 10.036	16.956 log10 (Copies/mL) Standard Deviation 10.388	15.726 log10 (Copies/mL) Standard Deviation 5.723

SECONDARY outcome

Timeframe: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

Population: All randomized participants who received at least one dose of study drug and had data for 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.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV n=4 Participants Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV n=5 Participants Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV n=5 Participants Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC	48.865 Cycles*day Standard Deviation 28.020	44.858 Cycles*day Standard Deviation 40.027	60.818 Cycles*day Standard Deviation 24.266	69.528 Cycles*day Standard Deviation 39.336

SECONDARY outcome

Timeframe: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

Population: All randomized participants who received at least one dose of study drug and had data for SARS-CoV-2 clearance.

Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV n=3 Participants Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV n=2 Participants Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV n=3 Participants Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance	NA Days Standard Deviation NA Not calculated as participant number is small.	7.7 Days Standard Deviation 7.0	NA Days Standard Deviation NA Not calculated as participant number is small.	15.7 Days Standard Deviation 11.2

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

700 mg LY3819253 IV

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

2800 mg LY3819253 IV

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

7000 mg LY3819253 IV

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo n=6 participants at risk Participants received single dose of Placebo as intravenous infusion.	700 mg LY3819253 IV n=6 participants at risk Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion.	2800 mg LY3819253 IV n=6 participants at risk Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion.	7000 mg LY3819253 IV n=6 participants at risk Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion.
Blood and lymphatic system disorders Leukopenia	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
General disorders Chest discomfort	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 2 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
General disorders Chills	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	33.3% 2/6 • Number of events 2 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Investigations Liver function test increased	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline through day 60 All randomized participants who received at least one dose of study drug.