Adults 18 to 75, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationPrimary· 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.
Group
Value
95% CI
Placebo
0
700 mg LY3819253 IV
0
2800 mg LY3819253 IV
0
7000 mg LY3819253 IV
0
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29Secondary· Day 29
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.
Group
Value
95% CI
700 mg LY3819253 IV
28.2
± 75
2800 mg LY3819253 IV
59.4
± 37
7000 mg LY3819253 IV
261
± 50
Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral LoadSecondary· Baseline, Day 29
Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.
Group
Value
95% CI
Placebo
10.476
± 7.117
700 mg LY3819253 IV
10.923
± 10.036
2800 mg LY3819253 IV
16.956
± 10.388
7000 mg LY3819253 IV
15.726
± 5.723
Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUCSecondary· 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.
Group
Value
95% CI
Placebo
48.865
± 28.020
700 mg LY3819253 IV
44.858
± 40.027
2800 mg LY3819253 IV
60.818
± 24.266
7000 mg LY3819253 IV
69.528
± 39.336
Pharmacodynamics (PD): Time to SARS-CoV-2 ClearanceSecondary· Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose
Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.
Group
Value
95% CI
Placebo
NA
± NA
700 mg LY3819253 IV
7.7
± 7.0
2800 mg LY3819253 IV
NA
± NA
7000 mg LY3819253 IV
15.7
± 11.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through day 60.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04537910 — A Study of LY3819253 (LY-CoV555) in Healthy Participants
· Phase 1
· completed
NCT05780268 — LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
· Phase 3
· completed
NCT04501978 — ACTIV-3: Therapeutics for Inpatients With COVID-19
· Phase 3
· completed
NCT04427501 — A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness
· Phase 2, PHASE3
· completed
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Currently open trials in the same condition.
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· Phase 1
· recruiting
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· Phase 2
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· Phase 3
· active not recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
· Phase 2
· not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
· Phase 2
· not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants
· Phase 1
· completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
· Phase 1
· completed
NCT07030127 — A Study of LY3985863 in Healthy Participants
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 12 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04411628.