A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness
Public ClinicalTrials.gov record NCT04427501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. 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. Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021. Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.
Study identification
- NCT ID
- NCT04427501
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 3,307 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 0 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 16, 2020
- Primary completion
- Feb 20, 2023
- Completion
- Feb 20, 2023
- Last update posted
- Apr 10, 2024
2020 – 2023
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinnova Research - Redondo Beach | Redondo Beach | California | 90277 | — |
| Bio-Medical Research, LLC | Miami | Florida | 33184 | — |
| Rophe Adult and Pediatric Medicine | Union City | Georgia | 30291 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| U of MA Mem Med Ctr | Worcester | Massachusetts | 01655 | — |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | — |
| Childrens Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Sky Clinical Prime and Health Wellness Clinic | Fayette | Mississippi | 39069 | — |
| Sky Clin Resch - Quinn HC | Ridgeland | Mississippi | 39157 | — |
| Monroe Biomed Research | Monroe | North Carolina | 28112 | — |
| B S & W Med Center | Dallas | Texas | 75246 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04427501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 10, 2024 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04427501 live on ClinicalTrials.gov.