LY3819253 for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
COVID-19+4 More
LY3819253 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test two drugs, LY3819253 and LY3832479, to see how effective they are against the virus that causes COVID-19. The drugs will be given to participants with early symptoms of COVID-19, and samples will be taken to determine how much virus is in the body at various times. Participation could last about 12 weeks.

Eligible Conditions
  • COVID-19
  • COVID19 (disease)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for COVID-19

Study Objectives

9 Primary · 23 Secondary · Reporting Duration: Baseline through Day 85

Baseline through Day 29
Percentage of Participants Enrolled with Recent Symptoms Prior to Randomization Who Experience COVID-Related Hospitalization or Death from Any Cause
Percentage of Participants Who Experience COVID-Related Hospitalization or Death from Any Cause
Phase 2: Time to SARS-CoV-2 Viral Clearance
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
Phase 3: Time to SARS-CoV-2 Viral Clearance
Phase 3: Time to Sustained Symptom Resolution
Time to SARS-CoV-2 Viral Clearance
Time to Sustained Symptom Resolution
Baseline through Day 85
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death from Any Cause
Percentage of Participants who Experience a Serious Adverse Event(s) SAE(s)
Pharmacokinetics (PK): Area Under the Concentration-time Curve from 0 to Infinity (AUC0-inf) for both LY3819253 and LY3832479
Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Baseline, Day 11
Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization
Change from Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Baseline, Day 7
Change from Baseline to Day 7 in SARS-CoV-2 Viral Load
Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Day 11
Percentage of Participants Demonstrating Symptom Improvement
Percentage of Participants Demonstrating Symptom Resolution
Phase 2: Percentage of Participants Demonstrating Symptom Improvement
Phase 2: Percentage of Participants Demonstrating Symptom Resolution
Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Day 29
PK: Mean Concentration of LY3832479 in the Presence of LY3819253
Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3819253 in the Presence of LY3832479
Day 29 Post-dose
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
Day 7
Percentage of Participants with SARS-CoV-2 Viral Load Greater than a Prespecified Threshold
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for COVID-19

Side Effects for

4200mg Bamlanivimab
2%Urinary tract infection
1%Back pain
1%Contusion
1%Blood pressure increased
1%Urticaria
1%Vertigo
1%Tooth infection
1%Tooth abscess
1%Fall
1%Arthralgia
1%Pain in extremity
1%Dizziness
1%Depression
1%Rash
1%Atrial fibrillation
1%Palpitations
1%Constipation
1%Gastrooesophageal reflux disease
1%Sepsis
1%Hypertension
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04497987) in the 4200mg Bamlanivimab ARM group. Side effects include: Urinary tract infection with 2%, Back pain with 1%, Contusion with 1%, Blood pressure increased with 1%, Urticaria with 1%.

Trial Design

4 Treatment Groups

LY3819253
1 of 4
LY3819253 + LY3832479
1 of 4
LY3853113 Open Label Addenda Arm 23
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

3360 Total Participants · 4 Treatment Groups

Primary Treatment: LY3819253 · Has Placebo Group · Phase 2 & 3

LY3819253
Drug
Experimental Group · 1 Intervention: LY3819253 · Intervention Types: Drug
LY3819253 + LY3832479Experimental Group · 2 Interventions: LY3819253, LY3832479 · Intervention Types: Drug, Drug
LY3853113 Open Label Addenda Arm 23
Drug
Experimental Group · 1 Intervention: LY3853113 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bamlanivimab
FDA approved
Etesevimab
Not yet FDA approved
LY3853113
2020
Completed Phase 2
~1760

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through day 85

Who is running the clinical trial?

Shanghai Junshi Bioscience Co., Ltd.OTHER
88 Previous Clinical Trials
20,035 Total Patients Enrolled
5 Trials studying COVID-19
3,085 Patients Enrolled for COVID-19
AbCellera Biologics Inc.Industry Sponsor
5 Previous Clinical Trials
3,070 Total Patients Enrolled
5 Trials studying COVID-19
3,070 Patients Enrolled for COVID-19
Eli Lilly and CompanyLead Sponsor
2,451 Previous Clinical Trials
3,117,324 Total Patients Enrolled
12 Trials studying COVID-19
12,497 Patients Enrolled for COVID-19
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,248 Previous Clinical Trials
364,152 Total Patients Enrolled
6 Trials studying COVID-19
3,189 Patients Enrolled for COVID-19

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You understand and agree to comply with the study procedures.
You agree to the collection of nasopharyngeal swabs and venous blood.
You must be at least 18 years of age.
You are not currently hospitalized
You have one or more mild or moderate COVID-19 symptoms.
You must have a sample taken for testing confirming viral infection no more than 3 days prior to starting the drug infusion.
You are a male or female, including pregnant females who agree to contraceptive requirements.
You give informed consent and/or assent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: October 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas50.0%
Maryland50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Maryland Medical Center33.3%
BioPharma Clinc Site33.3%
B S & W Med Center33.3%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
References