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NCT04411628 · ClinicalTrials.gov registry record · Phase 1
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
A Phase 1 study of COVID-19, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 11
- Study locations
NCT04411628: Completed Phase 1 study of COVID-19, sponsored by Eli Lilly and Company.
NCT04411628 is a Phase 1 study of COVID-19 that has completed, run by Eli Lilly and Company. The registered enrollment target is 26 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04411628, a Phase 1 study of COVID-19, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
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 Repo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LY3819253
Study Locations (11)
California
- Cedars Sinai Medical Center - Los Angeles
- Veterans Affairs Medical Center San Diego - San Diego
Massachusetts
- Massachusetts General Hospital - Boston
- University of Massachusetts Medical Center - Worcester
North Carolina
- University of North Carolina - Chapel Hill
- Unified Research Enterprise Brody School of Medicine at ECU - Greenville
Georgia
- Emory University - Atlanta
Michigan
- University of Michigan - Ann Arbor
Nebraska
- Quality Clinical Research, Inc. - Omaha
New York
- Alexandria Center for Life - NYC/ NYCEDC - New York
Pennsylvania
- Temple Univ School of Med - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2020-08-26 |
| Phase | Phase 1 |
What the finished NCT04411628 record still lists
NCT04411628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04411628 lists 11 locations in 8 states (California, Massachusetts, North Carolina).
Frequently Asked Questions
What is clinical trial NCT04411628 about?
NCT04411628 is a clinical study titled "A Study of LY3819253 (LY-CoV555) 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 co...
What is the current status of trial NCT04411628?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-05-28. Estimated completion is 2020-08-26.
What conditions does trial NCT04411628 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04411628?
The interventions under investigation include: Placebo (DRUG), LY3819253 (DRUG).
Who is sponsoring clinical trial NCT04411628?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04411628 being conducted?
This trial has 11 study locations across California, Georgia, Massachusetts, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04411628's enrollment target sits among peer trials
26 274th of 298 higher than 25 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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