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LY3819253Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug3040 vaccine candidate MVA-MERS-S Wiki 0.71
drug2418 TAK-981 Wiki 0.71
drug2326 Standard of care Wiki 0.16
drug1822 Placebo Wiki 0.08

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D019337 Hematologic Neoplasms NIH 0.27
D009369 Neoplasms, NIH 0.16
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0001909 Leukemia HPO 0.20
HP:0002664 Neoplasm HPO 0.16

There are 2 clinical trials

Clinical Trials

1 A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19

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.

NCT04411628 COVID-19 Drug: LY3819253 Drug: Placebo

Primary Outcomes

Description: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time: Baseline through Day 60

Secondary Outcomes

Description: PK: AUC of LY3819253

Measure: Pharmacokinetics (PK): Area Under the Concentration-time Curve (AUC) of LY3819253

Time: Baseline through Day 29

Description: PD: Change from Baseline in Viral Load

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

Time: Baseline, Day 29

2 A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3819253 in Participants With Mild to Moderate COVID-19 Illness

The purpose of this study is to measure how well LY3819253 works against the virus that causes COVID-19. LY3819253 will be given to participants with early symptoms of COVID-19, via an injection into a vein. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.

NCT04427501 COVID-19 Drug: LY3819253 Drug: Placebo

Primary Outcomes

Description: Change from Baseline to Day 11 in SARS-CoV-2 Viral Load

Measure: Change from Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load

Time: Baseline, Day 11

Secondary Outcomes

Description: Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization

Measure: Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization

Time: Baseline, Day 11

Description: PK: Mean Concentration of LY3819253

Measure: Pharmacokinetics (PK): Mean Concentration of LY3819253

Time: Day 29

Description: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death

Measure: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death

Time: Baseline through Day 29

No related HPO nodes (Using clinical trials)