ClinicalTrials.gov

History of Changes for Study: NCT04427501
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)
Latest version (submitted May 10, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 11, 2020 None (earliest Version on record)
2 June 11, 2020 Study Identification and Study Status
3 June 15, 2020 Recruitment Status, Contacts/Locations, Study Status and Oversight
4 June 22, 2020 Contacts/Locations and Study Status
5 June 25, 2020 Contacts/Locations and Study Status
6 June 26, 2020 Contacts/Locations and Study Status
7 June 30, 2020 Study Status
8 July 2, 2020 Contacts/Locations and Study Status
9 July 10, 2020 Contacts/Locations and Study Status
10 July 17, 2020 Contacts/Locations and Study Status
11 July 20, 2020 Eligibility, Study Description, Study Status and Study Identification
12 July 24, 2020 Contacts/Locations and Study Status
13 August 3, 2020 Contacts/Locations and Study Status
14 August 17, 2020 Contacts/Locations and Study Status
15 August 19, 2020 Contacts/Locations, Outcome Measures and Study Status
16 August 21, 2020 Outcome Measures, Arms and Interventions, Study Identification, Study Design, Study Description and Study Status
17 September 11, 2020 Contacts/Locations, Outcome Measures, Study Status, Eligibility, Study Design and Sponsor/Collaborators
18 September 15, 2020 Contacts/Locations, References, Study Identification and Study Status
19 September 17, 2020 Contacts/Locations and Study Status
20 November 9, 2020 Contacts/Locations, Study Status, Eligibility, Outcome Measures, Arms and Interventions and Study Design
21 November 11, 2020 Contacts/Locations and Study Status
22 November 13, 2020 Contacts/Locations and Study Status
23 December 1, 2020 Contacts/Locations and Study Status
24 December 2, 2020 Contacts/Locations and Study Status
25 December 3, 2020 Contacts/Locations and Study Status
26 December 14, 2020 Study Design, Study Status, Eligibility, Arms and Interventions and Study Identification
27 December 16, 2020 Contacts/Locations and Study Status
28 January 4, 2021 Contacts/Locations and Study Status
29 January 6, 2021 Study Design and Study Status
30 January 19, 2021 Study Status
31 January 25, 2021 Outcome Measures, Study Status, Eligibility and Study Design
32 February 1, 2021 Contacts/Locations and Study Status
33 February 15, 2021 Contacts/Locations and Study Status
34 March 12, 2021 Study Status, Eligibility, Arms and Interventions, Study Design, Outcome Measures and Study Description
35 March 24, 2021 Contacts/Locations, Eligibility, Outcome Measures, Study Design and Study Status
36 April 13, 2021 Contacts/Locations and Study Status
37 April 19, 2021 Contacts/Locations and Study Status
38 May 10, 2021 Contacts/Locations and Study Status
Comparison Format:

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Changes (Merged) for Study: NCT04427501
June 11, 2020 (v1) -- November 13, 2020 (v22)

Changes in: Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations and References

Open or close this module Study Identification
Unique Protocol ID: 17947
Brief Title: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Early Mild to Moderate COVID-19 Illness (BLAZE-1)
Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness
Secondary IDs: J2W-MC-PYAB [Eli Lilly and Company]
Open or close this module Study Status
Record Verification: June 1, 2020 November 2020
Overall Status: Not yet Recruiting
Study Start: June 13 17, 2020
Primary Completion: September 15 20, 2020 [ Anticipated Actual]
Study Completion: September 15 March 11, 2020 2021 [Anticipated]
First Submitted: June 9, 2020
First Submitted that
Met QC Criteria:
June 11, 2020
First Posted: June 11, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
June 11, 2020 November 13, 2020
Last Update Posted: June 11 November 16, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Eli Lilly and Company
Responsible Party: Sponsor
Collaborators: AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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, 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 may include at least 30 includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.
Detailed Description:
Open or close this module Conditions
Conditions: COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 2 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 400 1200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: LY3819253
LY3819253 administered intravenously (IV)
Drug: LY3819253
Administered IV
Other Names:
  • LY-CoV555
  • Bamlanivimab
Experimental: LY3819253 + LY3832479
LY3819253 + LY3832479 administered IV
Drug: LY3819253
Administered IV
Other Names:
  • LY-CoV555
  • Bamlanivimab
Drug: LY3832479
Administered IV
Other Names:
  • LY-CoV016
Placebo Comparator: Placebo
Placebo administered IV
Drug: Placebo
Administered IV
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Change from Baseline to Day 11 in SARS-CoV-2 Viral Load

[Time Frame: Baseline, Day 11]
2. Percentage of Participants Who Experience COVID-Related Hospitalization or Death
Percentage of Participants Who Experience COVID-Related Hospitalization or Death

[Time Frame: Baseline through Day 29]
3. Percentage of Participants with SARS-CoV-2 Viral Load Greater than a Prespecified Threshold
Percentage of Participants with SARS-CoV-2 Viral Load Greater than a Prespecified Threshold

[Time Frame: Day 7]
Secondary Outcome Measures:
4. 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 SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization

[Time Frame: Baseline, Day 11]
5. Percentage of Participants Demonstrating Symptom Resolution
Percentage of Participants Demonstrating Symptom Resolution

[Time Frame: Day 11]
6. Percentage of Participants Demonstrating Symptom Improvement
Percentage of Participants Demonstrating Symptom Improvement

[Time Frame: Day 11]
7. Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3819253 in the Presence of LY3832479
PK: Mean Concentration of LY3819253 and LY3819253 in the Presence of LY3832479

[Time Frame: Day 29]
8. Pharmacokinetics ( PK ) : Mean Concentration of LY3832479 in the Presence of LY3819253
PK: Mean Concentration of LY3832479 in the Presence of LY3819253

[Time Frame: Day 29]
9. Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room ( ER ) Visit, or Death

[Time Frame: Baseline through Day 29 85]
10. Change from Baseline to Day 7 in SARS-CoV-2 Viral Load
Change from Baseline to Day 7 in SARS-CoV-2 Viral Load

[Time Frame: Baseline, Day 7]
11. Percentage of Participants Enrolled with Recent Symptoms Prior to Randomization Who Experience COVID-Related Hospitalization or Death
Percentage of Participants Enrolled with Recent Symptoms Prior to Randomization Who Experience COVID-Related Hospitalization or Death

[Time Frame: Baseline through Day 29]
Open or close this module Eligibility
Minimum Age: 18 12 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Are currently not hospitalized
  • Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion
  • Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
  • Are men males or non-pregnant women females who agree to contraceptive requirements
  • Understand and agree to comply with planned study procedures
  • Agree to the collection of nasopharyngeal swabs and venous blood
  • The participant or legally authorized representative give signed informed consent and/or assent

Participants in treatment arms 7 and 8 ONLY

  • Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening
    • Are ≥65 years of age
    • Have a body mass index (BMI) ≥35
    • Have chronic kidney disease (CKD)
    • Have type 1 or type 2 diabetes
    • Have immunosuppressive disease
    • Are currently receiving immunosuppressive treatment or
    • Are ≥55 years of age AND have:
      • cardiovascular disease (CVD), OR
      • hypertension, OR
      • chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
  • Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
    • Have a body mass index (BMI) ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
    • Have sickle cell disease
    • Have congenital or acquired heart disease
    • Have neurodevelopmental disorders, for example, cerebral palsy
    • Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
    • Have asthma or reactive airway or other chronic respiratory disease
    • Have type 1 or type 2 diabetes
    • Have immunosuppressive disease, or
    • Are currently receiving immunosuppressive treatment

Exclusion Criteria:

  • Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute
  • Require mechanical ventilation or anticipated impending need for mechanical ventilation
  • Have known allergies to any of the components used in the formulation of the interventions
  • Have hemodynamic instability requiring use of pressors within 24 hours of randomization
  • Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
  • Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
  • Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study .
  • Have a history of a positive SARS-CoV-2 serology test prior to the one serving as eligibility for this study
  • Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
  • Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing Have received treatment with a SARS-CoV-2 specific monoclonal antibody
  • Have received treatment with a SARS-CoV-2 specific monoclonal antibody Have a history of convalescent COVID-19 plasma treatment
  • Have a history of convalescent COVID-19 plasma treatment Have participated in a previous SARS-CoV-2 vaccine study
  • Have participated in a previous SARS-CoV-2 vaccine study Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
  • Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Are pregnant or breast feeding
  • Are pregnant or breast feeding Have body weight <40 kilograms (kg)
Open or close this module Contacts/Locations
Central Contact Person: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Telephone: 1-317-615-4559
Email: ClinicalTrials.gov@lilly.com
Study Officials: 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 Director
Eli Lilly and Company
Locations: United States, Arizona
Arizona Clin Trials-Mesa
[Recruiting]
Mesa, Arizona, United States, 85210
Contact:Contact: 619-822-5941
Contact:Principal Investigator: Yessica Sachdeva
Banner Univ Med Ctr Phoenix
[Recruiting]
Phoenix, Arizona, United States, 85006
Contact:Contact: 305-216-2242
Contact:Principal Investigator: Marilyn Glassberg
Perseverance Research Center
[Recruiting]
Scottsdale, Arizona, United States, 85254
Contact:Contact: 480-471-6132
Contact:Principal Investigator: Kenneth Steil
CRI of Arizona, LLC
[Recruiting]
Surprise, Arizona, United States, 85374
Contact:Contact: 623-223-1580
Contact:Principal Investigator: Jalal Abbas
Fiel Family Medicine
[Recruiting]
Tempe, Arizona, United States, 85283
Contact:Contact: 480-831-6328
Contact:Principal Investigator: Thomas Fiel
Orange Grove Banner Clinic
[Recruiting]
Tucson, Arizona, United States, 85704
Contact:Contact: 520-626-2038
Contact:Principal Investigator: Jarrod Mosier
Arizona Clin Trials-Tucson
[Recruiting]
Tucson, Arizona, United States, 85712
Contact:Contact: 434-825-0921
Contact:Principal Investigator: Anita Kohli
United States, Arkansas
Arkansas Clinical Research
[Recruiting]
Little Rock, Arkansas, United States, 72205
Contact:Contact: 501-907-9170
Contact:Principal Investigator: Kevin D Roberts
Applied Rsch Ctr - Arkansas Inc.
[Not yet recruiting]
Little Rock, Arkansas, United States, 72212
Contact:Contact: 501-954-7822
Contact:Principal Investigator: Lee Wilbur
United States, California
Hope Clinical Research
[Recruiting]
Canoga Park, California, United States, 91303
Contact:Contact: 818-999-4673
Contact:Principal Investigator: Hessam Aazami
VCT-Covina
[Recruiting]
Covina, California, United States, 91723
Contact:Contact: 626-598-4952
Contact:Principal Investigator: Masoud Azizad
AMCR Institute
[Not yet recruiting]
Escondido, California, United States, 92025
Contact:Contact: 760-466-1530
Contact:Principal Investigator: Timothy S. Bailey
Valley Research
[Not yet recruiting]
Fresno, California, United States, 93720
Contact:Contact: 5592610992
Contact:Principal Investigator: Paul Carlton Norwood
Chemidox Clinical Trials
[Not yet recruiting]
Lancaster, California, United States, 93534
Contact:Contact: 833-324-3643
Contact:Principal Investigator: Alon Antebi
Long Beach Clinical Trials LLC
[Recruiting]
Long Beach, California, United States, 90806
Contact:Contact: 562-436-4761
Contact:Principal Investigator: Barry Heller
United States, California
Cedars Sinai Medical Center
[Recruiting]
Los Angeles, California, United States, 90048-5615
Contact:Contact: 833-277-0197 424-315-2861
Contact:Principal Investigator: P Peter Chen
Central Valley Research, LLC
[Recruiting]
Modesto, California, United States, 95350
Contact:Contact: 209-549-9538
Contact:Principal Investigator: Faisal Amin
Catalina Research Institute, LLC
[Recruiting]
Montclair, California, United States, 91763
Contact:Contact: 909-590-8409
Contact:Principal Investigator: Rizwana H Mohseni
University of CA, Irvine
[Recruiting]
Orange, California, United States, 92868
Contact:Contact: 714-456-5501
Contact:Principal Investigator: Donald Forthal
Western University of Health Sciences
[Recruiting]
Pomona, California, United States, 91766
Contact:Principal Investigator: Nader Sobh
Inland Empire CT, LLC
[Recruiting]
Rialto, California, United States, 92377
Contact:Contact: 909-883-2999
Contact:Principal Investigator: Zeid Kayali
Sutter Institute For Medical Research
[Not yet recruiting]
Sacramento, California, United States, 95816
Contact:Contact: 916-478-6561
Contact:Principal Investigator: Aaron Kinney
Long Beach Clinical Trials LLC Zion Medical Center
[Recruiting]
Long Beach San Diego, California, United States, 90806 92120
Contact:Contact: 833-277-0197 619-528-5009
Contact:Principal Investigator: B Heller Adam Schwartz
Kaiser Permanente - SD Med Ctr
[Active, not recruiting]
San Diego, California, United States, 92123
Wolverine Clinical Trials, LLC
[Recruiting]
Santa Ana, California, United States, 92705
Contact:Contact: 7146172426
Contact:Principal Investigator: Wayne Wei-Chin Chen
St. Joe Heritage HC-Santa Rosa
[Not yet recruiting]
Santa Rosa, California, United States, 95405
Contact:Contact: 707-890-4100
Contact:Principal Investigator: David Della Lana
Stanford University Hospital
[Recruiting]
Palo Alto Stanford, California, United States, 94304 94305
Contact:Contact: 833-277-0197 650-723-9656
Contact:Principal Investigator: A Andra Blomkalns
Mazur, Statner, Dutta, Nathan
[Recruiting]
Thousand Oaks, California, United States, 91360
Contact:Contact: 310-890-2713
Contact:Principal Investigator: Ramesh Nathan
Infect Disease Doctors Med Grp
[Recruiting]
Walnut Creek, California, United States, 94598
Contact:Contact: 925-947-2334
Contact:Principal Investigator: Bhavna Malik
Allianz Research Institute
[Recruiting]
Westminster, California, United States, 92683
Contact:Contact: 714-887-0400
Contact:Principal Investigator: David Pham
United States, District of Columbia
Georgetown Univ Sch of Med
[Recruiting]
Washington, District of Columbia, United States, 20007
Contact:Contact: 202-444-0086
Contact:Principal Investigator: Princy Kumar
United States, Florida
Synergy Healthcare LLC
[Not yet recruiting]
Bradenton, Florida, United States, 34208
Contact:Contact: 941-896-4948
Contact:Principal Investigator: Patrick Weston
Holy Cross Hospital Inc.
[Recruiting]
Fort Lauderdale, Florida, United States, 33308
Contact:Contact: 9542298400
Contact:Principal Investigator: Joshua Michael Purow
I R & Health Center, Inc.
[Recruiting]
Hialeah, Florida, United States, 33012
Contact:Contact: 305-825-6588
Contact:Principal Investigator: Jose Cardona
Encore Medical Research
[Not yet recruiting]
Hollywood, Florida, United States, 33021
Contact:Contact: 954-400-1725
Contact:Principal Investigator: Rodolfo Perez
United States, Indiana
Community Hospital South
Indianapolis, Indiana, United States, 46227
Contact:Contact: 833-277-0197
Contact:Principal Investigator: P Milligan
Elixia CRC
[Not yet recruiting]
Hollywood, Florida, United States, 33023
Contact:Contact: 786-267-8166
Contact:Principal Investigator: Steven Zeig
University of Florida Jacksonville
[Recruiting]
Jacksonville, Florida, United States, 32209
Contact:Contact: 904-798-4179
Contact:Principal Investigator: Mobeen Rathore
Miami Cancer Institute at Baptist Health, Inc.
[Recruiting]
Miami, Florida, United States, 33176
Contact:Contact: 305-728-1848
Contact:Principal Investigator: Guenther Koehne
Panax Clinical Research
[Not yet recruiting]
Miami Lakes, Florida, United States, 33014
Contact:Contact: 305-698-4500
Contact:Principal Investigator: Robert Perry
GCPR
[Recruiting]
Saint Petersburg, Florida, United States, 33702
Contact:Contact: 727-520-1427
Contact:Principal Investigator: Roxana Stoici
Testing Matters Lab
[Not yet recruiting]
Sunrise, Florida, United States, 33325
Contact:Contact: 786-267-8166
Contact:Principal Investigator: Steven Zeig
Advent Health Tampa
[Recruiting]
Tampa, Florida, United States, 33613
Contact:Contact: 813-597-8697
Contact:Principal Investigator: Elvis Castillo
Triple O Research Inst
[Not yet recruiting]
West Palm Beach, Florida, United States, 33407
Contact:Contact: 561-855-7871
Contact:Principal Investigator: Olayemi Osiyemi
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Contact:Contact: 833-277-0197
Contact:Principal Investigator: J Glassberg
Cleveland Clinic of Weston Florida
[Not yet recruiting]
Weston, Florida, United States, 33331
Contact:Contact: 954-659-5165
Contact:Principal Investigator: Carla McWilliams
Florida Pulmonary Research Institute LLC
[Not yet recruiting]
Winter Park, Florida, United States, 32789
Contact:Contact: 407-740-8078
Contact:Principal Investigator: Faisal A Fakih
United States, Ohio
Ohio State Univ College Of Medicine
Columbus, Ohio, United States, 43210
Contact:Contact: 833-277-0197
Contact:Principal Investigator: C Malvestutto
United States, Georgia
Gwinnett Research Inst
[Recruiting]
Buford, Georgia, United States, 30519
Contact:Contact: 470-326-3358
Contact:Principal Investigator: Alexander E. Osowa
Paramount Rch Sol - College Pk
[Not yet recruiting]
College Park, Georgia, United States, 30349
Contact:Contact: 404-657-4500
Contact:Principal Investigator: Michelle Evans
IACT Health - VHC
[Recruiting]
Columbus, Georgia, United States, 31903
Contact:Contact: 888-737-7408
Contact:Principal Investigator: Jeffrey K Kingsley
Central Georgia Infectious Disease
[Not yet recruiting]
Macon, Georgia, United States, 31201
Contact:Contact: 478-741-5945
Contact:Principal Investigator: Quyen Luu
United States, Idaho
Rocky Mountain Clinical Research
[Not yet recruiting]
Idaho Falls, Idaho, United States, 83404
Contact:Contact: 208-522-6005
Contact:Principal Investigator: Carl D Vance
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Contact:Contact: 833-277-0197
Contact:Principal Investigator: V Stosor
Northwestern University
[Active, not recruiting]
Chicago, Illinois, United States, 60611
J H. Stroger Hosp of Cook Co
[Recruiting]
Chicago, Illinois, United States, 60612
Contact:Contact: 312-572-4575
Contact:Principal Investigator: Gregory Huhn
University of Chicago Medical Chi Med Center
[Recruiting]
Chicago, Illinois, United States, 60637
Contact:Contact: 833-277-0197 773-702-9078
Contact:Principal Investigator: D David Pitrak
Great Lakes Clinical Trials
[Recruiting]
Chicago, Illinois, United States, 60640
Contact:Contact: 773-275-3500
Contact:Principal Investigator: Yevgeniy Bukhman
United States, Indiana
Franciscan Health Hammond
[Recruiting]
Hammond Dyer, Indiana, United States, 46320 46311
Contact:Contact: 833-277-0197 323-388-7946
Contact:Principal Investigator: E Erica Kaufman West
Qualmedica Research Evansville
[Recruiting]
Evansville, Indiana, United States, 47715
Contact:Contact: 812-205-2475
Contact:Principal Investigator: David Schultz
Community Hospital South
[Active, not recruiting]
Indianapolis, Indiana, United States, 46227
Franciscan St. Francis Health
[Recruiting]
Indianapolis, Indiana, United States, 46237
Contact:Contact: 833-277-0197 317-528-8786
Contact:Principal Investigator: I Imad J Shawa
St.Vincent - Indy
[Not yet recruiting]
Indianapolis, Indiana, United States, 46260
Contact:Contact: 317-582-8180
Contact:Principal Investigator: Francisco Delgado
United States, Kentucky
Qualmedica Research, LLC
[Not yet recruiting]
Owensboro, Kentucky, United States, 42301
Contact:Contact: 812-550-3197
Contact:Principal Investigator: Christopher Sartore
United States, Louisiana
Tandem Clinical Research,LLC
[Recruiting]
Marrero, Louisiana, United States, 70072
Contact:Contact: 504-934-8424
Contact:Principal Investigator: Adil Fatakia
CAR d/b/a CT of SWLA, LLC
[Recruiting]
Moss Bluff, Louisiana, United States, 70611
Contact:Contact: 337-602-6642
Contact:Principal Investigator: Jason Morris
Nola Research Works, LLC
[Recruiting]
New Orleans, Louisiana, United States, 70125
Contact:Contact: 504-891-3613
Contact:Principal Investigator: Corey Hebert
United States, Maryland
University of Maryland Medical Center
[Not yet recruiting]
Baltimore, Maryland, United States, 21201
Contact:Principal Investigator: R. Gentry Wilkerson
United States, Massachusetts
Massachusetts General Hospital
Chelsea, Massachusetts, United States, 02150
Contact:Contact: 833-277-0197
Contact:Principal Investigator: M L Dougan
The Johns Hopkins Hospital
[Not yet recruiting]
Baltimore, Maryland, United States, 21287
Contact:Contact: 443-287-0517
Contact:Principal Investigator: Kelly Dooley
United States, Massachusetts
Massachusetts General Hospital
[Recruiting]
Boston, Massachusetts, United States, 02114
Contact:Contact: 833-277-0197 617-724-8420
Contact:Principal Investigator: M Michael L Dougan
U of MA Mem Med Ctr
[Recruiting]
Worcester, Massachusetts, United States, 01605
Contact:Contact: 508-334-1000
Contact:Principal Investigator: ROBERT FINBERG
United States, Michigan
Great Lakes Research Group, Inc.
[Not yet recruiting]
Bay City, Michigan, United States, 48706
Contact:Contact: 989-895-9100
Contact:Principal Investigator: Jeffrey A. Potts
United States, Michigan
Henry Ford Hospital
[Recruiting]
Detroit, Michigan, United States, 48202
Contact:Contact: 833-277-0197 313-623-2531
Contact:Principal Investigator: M Mayur Ramesh
Revive Research Institute
[Not yet recruiting]
Farmington Hills, Michigan, United States, 48334
Contact:Contact: 248-564-1485
Contact:Principal Investigator: Barry Feldman
Revival Research Institute
[Not yet recruiting]
Sterling Heights, Michigan, United States, 48312
Contact:Contact: 248-721-9539
Contact:Principal Investigator: Abdulhassan Saad
United States, Mississippi
Olive Branch Family Medical Center
[Recruiting]
Olive Branch, Mississippi, United States, 38654
Contact:Contact: 6628954949
Contact:Principal Investigator: Randall Toombs Huling
Sky Clin Resch - Quinn HC
[Not yet recruiting]
Ridgeland, Mississippi, United States, 39157
Contact:Contact: 601-487-6482
Contact:Principal Investigator: Timothy Quinn
United States, Missouri
QPS Missouri
[Not yet recruiting]
Springfield, Missouri, United States, 65802
Contact:Contact: 417-893-6103
Contact:Principal Investigator: Kayce Morton
United States, Nebraska
Quality Clinical Research, Inc.
[Recruiting]
Omaha, Nebraska, United States, 68114
Contact:Contact: 402-934-0044
Contact:Principal Investigator: Michael Dunn
United States, Nevada
Excel Clinical Research
[Recruiting]
Las Vegas, Nevada, United States, 89109
Contact:Contact: 702-680-1500
Contact:Principal Investigator: Duane Anderson
Las Vegas Medical Research
[Recruiting]
Las Vegas, Nevada, United States, 89113
Contact:Contact: 702-612-8127
Contact:Principal Investigator: Bharat R Mocherla
United States, New Jersey
Holy Name Medical Center
[Not yet recruiting]
Teaneck, New Jersey, United States, 07666
Contact:Contact: 201-503-0660
Contact:Principal Investigator: Suraj Saggar
United States, New York
Care Access Research - Bronx
[Recruiting]
Bronx, New York, United States, 10456
Contact:Contact: 718-530-0051
Contact:Principal Investigator: Rubaba Hussain
Icahn Sch of Med at Mt. Sinai
[Active, not recruiting]
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
[Recruiting]
Chapel Hill, North Carolina, United States, 27599
Contact:Contact: 833-277-0197 410-908-7779
Contact:Principal Investigator: W William A Fischer
East Carolina University
[Recruiting]
Greenville, North Carolina, United States, 27834
Contact:Contact: 252-744-0860
Contact:Principal Investigator: Paul P Cook
Monroe Biomed Research
[Not yet recruiting]
Monroe, North Carolina, United States, 28112
Contact:Contact: 704-283-7369
Contact:Principal Investigator: Awawu Igbinadolor
Carteret Medical Group
[Not yet recruiting]
Morehead City, North Carolina, United States, 28557
Contact:Contact: 2527279501
Contact:Principal Investigator: Mary Katherine Lawrence
Carolina Research Center, Inc.
[Not yet recruiting]
Shelby, North Carolina, United States, 28150
Contact:Contact: 705-787-5228
Contact:Principal Investigator: Stephen W Jones
PMG Research of Wilmington
[Not yet recruiting]
Wilmington, North Carolina, United States, 28401
Contact:Contact: 910-815-6108
Contact:Principal Investigator: Kevin D Cannon
United States, Ohio
Hometown UC and Rch- Cincy
[Not yet recruiting]
Cincinnati, Ohio, United States, 45215
Contact:Contact: 937-293-2157
Contact:Principal Investigator: Blaise Gatto
United States, Ohio
Cleveland Clinic Foundation
[Recruiting]
Cleveland, Ohio, United States, 44195
Contact:Contact: 833-277-0197 216-445-5429
Contact:Principal Investigator: K Kristin Highland
OH State Univ College of Med
[Active, not recruiting]
Columbus, Ohio, United States, 43210
Aventiv Research Inc
[Recruiting]
Columbus, Ohio, United States, 43213
Contact:Contact: 614-501-6164
Contact:Principal Investigator: Samir Arora
Urgent Care Specialists, LLC
[Recruiting]
Columbus, Ohio, United States, 43214
Contact:Contact: 674-263-4400
Contact:Principal Investigator: Narinder Saini
Remington-Davis, Inc
[Recruiting]
Columbus, Ohio, United States, 43215
Contact:Contact: 614-487-2560
Contact:Principal Investigator: Brian Zeno
Urgent Care Specialists, LLC
[Not yet recruiting]
Dayton, Ohio, United States, 45424
Contact:Contact: 937-912-4444
Contact:Principal Investigator: Steve Choi
META Medical Research Institute, LLC
[Recruiting]
Dayton, Ohio, United States, 45432
Contact:Contact: 937-252-2000
Contact:Principal Investigator: Priyesh Mehta
United States, Oklahoma
Ascension St. John Tulsa OK
[Recruiting]
Tulsa, Oklahoma, United States, 74104
Contact:Contact: 918-744-3426
Contact:Principal Investigator: Anuj Malik
United States, Pennsylvania
Jefferson Hosp for Neurosci
[Recruiting]
Philadelphia, Pennsylvania, United States, 19107
Contact:Contact: 215-955-2007
Contact:Principal Investigator: Katherine Belden
United States, Pennsylvania
Temple University School of Medicine Hospital
[Recruiting]
Philadelphia, Pennsylvania, United States, 19140
Contact:Contact: 833-277-0197 215-707-1359
Contact:Principal Investigator: G GERARD J CRINER
United States, South Carolina
VITALINK - Anderson
[Recruiting]
Anderson, South Carolina, United States, 29621
Contact:Contact: 864-965-0190
Contact:Principal Investigator: Charles Thompson
United States, Texas
Baylor Scott & White Cancer Center
Dallas, Texas, United States, 75246
Contact:Contact: 833-277-0197
Contact:Principal Investigator: R Gottlieb
VITALINK - Gaffney
[Recruiting]
Gaffney, South Carolina, United States, 29340
Contact:Contact: 864-488-1283
Contact:Principal Investigator: David Erb
VITALINK - Greenville
[Recruiting]
Greenville, South Carolina, United States, 29615
Contact:Contact: 864-770-0890
Contact:Principal Investigator: Luis de la Cruz
VITALINK - Spartanburg
[Recruiting]
Spartanburg, South Carolina, United States, 29303
Contact:Contact: 864-515-0092
Contact:Principal Investigator: Gregory Feldman
VITALINK - Union
[Recruiting]
Union, South Carolina, United States, 29379
Contact:Contact: 864-427-1172
Contact:Principal Investigator: Joseph Boscia
United States, Tennessee
Univ Diab & Endo Consult
[Recruiting]
Chattanooga, Tennessee, United States, 37411
Contact:Contact: 423-265-3561
Contact:Principal Investigator: David Huffman
New Phase R and D
[Recruiting]
Knoxville, Tennessee, United States, 37909
Contact:Contact: 865-200-8364
Contact:Principal Investigator: Evelyne Davidson
United States, Texas
Central Texas Clinical Rch
[Recruiting]
Austin, Texas, United States, 78705
Contact:Contact: 512-480-9660
Contact:Principal Investigator: Cynthia C Brinson
Gadolin Research, LLC
[Recruiting]
Beaumont, Texas, United States, 77702
Contact:Contact: 409-331-6040
Contact:Principal Investigator: Russell Perry
Crossroads Clinical Research
[Recruiting]
Corpus Christi, Texas, United States, 78413
Contact:Contact: 361-288-4668
Contact:Principal Investigator: Michael Winnie
B S & W Med Center
[Recruiting]
Dallas, Texas, United States, 75246
Contact:Contact: 408-444-5823
Contact:Principal Investigator: Robert Gottlieb
Baylor - Fort Worth
[Not yet recruiting]
Fort Worth, Texas, United States, 76104
Contact:Contact: 888-50-RESEARCH (73732724)
Contact:Principal Investigator: Robert Gottlieb
Houston Methodist Research Ins
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: 713-441-9793
Contact:Principal Investigator: Howard Huang
Next Level Urgent Care
[Recruiting]
Houston, Texas, United States, 77057
Contact:Contact: 832-460-3311
Contact:Principal Investigator: Wilner E. Jeudy
Centex-Houston
[Recruiting]
Houston, Texas, United States, 77058
Contact:Contact: 281-282-0808
Contact:Principal Investigator: Joe Pouzar
BioPharma Clinc Site
[Recruiting]
Houston, Texas, United States, 77090
Contact:Contact: 832-818-8115
Contact:Principal Investigator: Victor Escobar
Centex-Wesfield
[Recruiting]
Houston, Texas, United States, 77090
Contact:Contact: 281-786-1660
Contact:Principal Investigator: Ali Bajwa
B S & W Med Center
[Recruiting]
Irving, Texas, United States, 75061
Contact:Contact: 888-50-RESEARCH (73732724)
Contact:Principal Investigator: Robert Gottlieb
BioPharma Family Practice Center McAllen
[Recruiting]
McAllen, Texas, United States, 78501
Contact:Contact: 956-668-0044
Contact:Principal Investigator: Manuel Sanchez
North Hills Medical Research
[Recruiting]
North Richland Hills, Texas, United States, 76180
Contact:Contact: 817-595-3399
Contact:Principal Investigator: John Gabriel
Bay Area Infectious Diseases Associates
[Recruiting]
Pasadena, Texas, United States, 77505
Contact:Contact: 281-991-7999
Contact:Principal Investigator: Zaher Shebib
Baylor - Round Rock
[Recruiting]
Round Rock, Texas, United States, 78665
Contact:Contact: 888-50-RESEARCH (73732724)
Contact:Principal Investigator: Robert Gottlieb
Sun Research Institute
[Not yet recruiting]
San Antonio, Texas, United States, 78215
Contact:Contact: 210-277-1289
Contact:Principal Investigator: Carl Dukes
Consano Clinical Research, LLC
[Recruiting]
Shavano Park, Texas, United States, 78231
Contact:Contact: 210-545-4900
Contact:Principal Investigator: Michelle Welch
APD Clinical Research
[Recruiting]
Splendora, Texas, United States, 77372
Contact:Contact: 281-370-7272
Contact:Principal Investigator: Najmuddin Karimjee
Crossroads Clin Rch-Victoria
[Recruiting]
Victoria, Texas, United States, 77901
Contact:Contact: 361-574-7800
Contact:Principal Investigator: Omesh Verma
CLS Research Ctr, PLLC
[Recruiting]
Webster, Texas, United States, 77598
Contact:Contact: 281-724-8180
Contact:Principal Investigator: Husam Issa
United States, Virginia
CARE ID
[Recruiting]
Annandale, Virginia, United States, 22003
Contact:Contact: 703-560-4821
Contact:Principal Investigator: David Wheeler
United States, Washington
Evergreen Health Research
[Recruiting]
Kirkland, Washington, United States, 98034
Contact:Contact: 512-751-5496
Contact:Principal Investigator: Chad Crystal
Puerto Rico
Dorado Medical Complex Inc
[Not yet recruiting]
Dorado, Puerto Rico, 00646
Contact:Contact: 7872781576
Contact:Principal Investigator: Luis Pagan-Cardona
GCM Medical Group, PSC- Hato Rey
[Not yet recruiting]
San Juan, Puerto Rico, 00917
Contact:Contact: 7879362100
Contact:Principal Investigator: Gregorio A. Cortes-Maisonet
Open or close this module IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
Access Criteria:
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
URL: http://vivli.org/
Open or close this module References
Citations:
Links: Description: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)
Available IPD/Information:

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