COVID-19
Conditions
Brief summary
The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.
Interventions
DRUGLY3819253
Administered IV.
DRUGPlacebo
Administered IV.
Sponsors
AbCellera Biologics Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Are hospitalized or in the process of being admitted to hospital and have an initial laboratory determination of current COVID-19 infection less than or equal to (≤)72 hours prior to randomization * Are men or non-pregnant women * Women of childbearing potential must agree to use at least one highly effective form of contraception for the entirety of the study * Agree to the collection of nasopharyngeal swabs and venous blood
Exclusion criteria
* Require mechanical ventilation or anticipated impending need for mechanical ventilation * Received convalescent COVID-19 plasma treatment prior to enrollment * Were resident in a nursing home or long-term care facility immediately prior to current hospitalization * Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product * Have an oxygen saturation (SpO2) less than (\<)88 percent (%) while breathing room air at rest at randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 | Day 29 | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29. |
| Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load | Baseline, Day 29 | Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load. |
| Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose | 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. |
| Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose | Pharmacodynamics (PD): Time to SARS-CoV-2 clearance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received single dose of Placebo as intravenous infusion. | 6 |
| 700 mg LY3819253 IV Participants received single dose of 700 milligrams (mg) LY3819253 administered as intravenous infusion. | 6 |
| 2800 mg LY3819253 IV Participants received single dose of 2800 mg LY3819253 administered as intravenous infusion. | 6 |
| 7000 mg LY3819253 IV Participants received single dose of 7000 mg LY3819253 administered as intravenous infusion. | 6 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | 700 mg LY3819253 IV | 2800 mg LY3819253 IV | 7000 mg LY3819253 IV | Total |
|---|---|---|---|---|---|
| Age, Continuous | 43.2 Years STANDARD_DEVIATION 8.6 | 57.2 Years STANDARD_DEVIATION 6.8 | 48.5 Years STANDARD_DEVIATION 12.1 | 66.7 Years STANDARD_DEVIATION 6.7 | 53.9 Years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 19 Participants |
| Region of Enrollment United States | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 24 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 4 / 6 | 5 / 6 | 5 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
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.
Time frame: Baseline through Day 60
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 |
| 700 mg LY3819253 IV | 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 |
| 2800 mg LY3819253 IV | 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 |
| 7000 mg LY3819253 IV | 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 |
Secondary
Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load
Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load | 10.476 log10 (Copies/mL) | Standard Deviation 7.117 |
| 700 mg LY3819253 IV | Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load | 10.923 log10 (Copies/mL) | Standard Deviation 10.036 |
| 2800 mg LY3819253 IV | Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load | 16.956 log10 (Copies/mL) | Standard Deviation 10.388 |
| 7000 mg LY3819253 IV | Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load | 15.726 log10 (Copies/mL) | Standard Deviation 5.723 |
Secondary
Pharmacodynamics (PD): 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | 48.865 Cycles*day | Standard Deviation 28.02 |
| 700 mg LY3819253 IV | Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | 44.858 Cycles*day | Standard Deviation 40.027 |
| 2800 mg LY3819253 IV | Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | 60.818 Cycles*day | Standard Deviation 24.266 |
| 7000 mg LY3819253 IV | Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | 69.528 Cycles*day | Standard Deviation 39.336 |
Secondary
Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance
Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | NA Days | — |
| 700 mg LY3819253 IV | Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | 7.7 Days | Standard Deviation 7 |
| 2800 mg LY3819253 IV | Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | NA Days | — |
| 7000 mg LY3819253 IV | Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | 15.7 Days | Standard Deviation 11.2 |
Secondary
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.
Time frame: Day 29
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 | 28.2 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 75 |
| 700 mg LY3819253 IV | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 | 59.4 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 37 |
| 2800 mg LY3819253 IV | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 | 261 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 50 |