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LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LY3819253
Placebo
Remdesivir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3, TICO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Criteria: Non-pregnant female participants who are of reproductive potential and male participants who are able to father a child must abstain from male/female sexual intercourse or agree to use two forms of effective contraception, where at least one form is highly effective (less than 1% failure rate), for the entirety of the study and for 90 days after investigational agent is administered. Highly effective methods of contraception (less than 1% failure rate) include, but are not limited to: combination oral contraceptives implanted contraceptives intrauterine devices Effective methods of contraception include, but are not limited to: diaphragms and cervical caps with spermicide cervical sponges condoms with spermicide NOTE: Use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these barrier methods are combined. Barrier protection methods without concomitant use of a spermicide are not an effective or acceptable method of contraception. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), and withdrawal are not acceptable methods of contraception. Participants not of reproductive potential are eligible without requiring the use of a contraceptive method. Participant-reported history is acceptable documentation of surgical sterilization and menopause. Participants with pregnant partners should use condoms during vaginal intercourse through 90 days after investigational agent administration. Participants should refrain from sperm donation through 90 days after investigational agent administration. NOTE: Reproductive potential is defined as patients who have reached menarche, who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) ≥ 40 IU/ml or 24 consecutive months if an FSH is not available, who have not undergone surgical sterilization, who do not have other clinical condition that could induce amenorrhea, who are not taking medications such as oral contraceptives, hormones, gonadotropin releasing hormone, antiestrogens, selective estrogen receptor modulators (SERMs) or chemotherapy that could induce amenorrhea. Individuals with permanent infertility due to an alternate medical cause (e.g. Mullerian agenesis, androgen insensitivity), investigator discretion should be applied.

Sites / Locations

  • Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
  • Community Regional Medical Center (Site 203-005), 2823 Fresno Street
  • Keck Hospital of USC (Site 301-020), 1500 San Pablo Street
  • UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
  • San Francisco VAMC (Site 074-002), 4150 Clement St.
  • UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.
  • Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
  • University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
  • Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)
  • MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW
  • Miami VAMC (Site 074-003), 1201 NW 16 Street
  • Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
  • University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.
  • Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
  • University of Maryland Medical Center (Site 301-019), 22 South Greene Street
  • Massachusetts General Hospital (Site 202-002), 55 Fruit Street
  • Baystate Medical Center (Site 201-001), 759 Chestnut Street
  • University of Michigan (Site 205-001), 1500 East Medical Center Drive
  • Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
  • Hennepin Healthcare (Site 027-001), 701 Park Avenue
  • University of Mississippi Medical Center (Site 202-005), 2500 North State Street
  • Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
  • Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road
  • Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
  • Duke University Hospital (Site 301-006), 2301 Erwin Road
  • Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
  • Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue
  • Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue
  • Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road
  • Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
  • Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
  • UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
  • Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
  • Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street
  • Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.
  • Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
  • University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
  • University of Virginia Health Systems (Site 301-021), 1215 Lee Street
  • Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street
  • Harborview Medical Center (Site 208-001), 325 9th Avenue
  • University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street
  • West Virginia University (Site 301-023), One Medical Center Drive
  • Aalborg Hospital (Site 625-005), Hobrovej 18
  • Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
  • Righospitalet (Site 625-006), Blegdamsvej 9,
  • Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
  • Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
  • Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30
  • Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
  • Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
  • Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
  • Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n
  • Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29
  • Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170
  • Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46
  • Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN
  • UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3819253 plus SOC

Placebo plus SOC

Arm Description

LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion

Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion

Outcomes

Primary Outcome Measures

Number of Participants With Sustained Recovery
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Number of Participants With an Ordinal Outcome on Day 5
Ordinal outcome with 7 mutually exclusive categories

Secondary Outcome Measures

Number of Participants Who Died From All Causes
All-cause mortality
Number of Participants With a Safety Outcome Through Day 5
Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5
Number of Participants With a Safety Outcome Through Day 28
Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28
Number of Participants With a Safety Outcome Through Day 90
Death, SAE, clinical organ failure, serious infections through Day 90

Full Information

First Posted
March 20, 2023
Last Updated
September 12, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05780268
Brief Title
LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Official Title
A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H1: LY3819253 (LY-CoV555))
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study looks at the safety and effectiveness of LY3819253 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either LY3819253 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H1.
Detailed Description
This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of LY3819253 in hospitalized patients infected with COVID-19. This is a randomized, blinded, controlled sub-study of LY3819253 plus current standard of care (SOC) against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo. Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: Participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2). An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5. If LY3819253 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization. This trial will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3, TICO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3819253 plus SOC
Arm Type
Experimental
Arm Description
LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Arm Title
Placebo plus SOC
Arm Type
Placebo Comparator
Arm Description
Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Intervention Type
Biological
Intervention Name(s)
LY3819253
Intervention Description
LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Commercially available 0.9% sodium chloride solution
Intervention Type
Biological
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
Veklury
Intervention Description
Antiviral agent
Primary Outcome Measure Information:
Title
Number of Participants With Sustained Recovery
Description
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Time Frame
Through Day 90
Title
Number of Participants With an Ordinal Outcome on Day 5
Description
Ordinal outcome with 7 mutually exclusive categories
Time Frame
Status on Day 5
Secondary Outcome Measure Information:
Title
Number of Participants Who Died From All Causes
Description
All-cause mortality
Time Frame
Through Day 90
Title
Number of Participants With a Safety Outcome Through Day 5
Description
Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5
Time Frame
Through Day 5
Title
Number of Participants With a Safety Outcome Through Day 28
Description
Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28
Time Frame
Through Day 28
Title
Number of Participants With a Safety Outcome Through Day 90
Description
Death, SAE, clinical organ failure, serious infections through Day 90
Time Frame
Through Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Criteria: Non-pregnant female participants who are of reproductive potential and male participants who are able to father a child must abstain from male/female sexual intercourse or agree to use two forms of effective contraception, where at least one form is highly effective (less than 1% failure rate), for the entirety of the study and for 90 days after investigational agent is administered. Highly effective methods of contraception (less than 1% failure rate) include, but are not limited to: combination oral contraceptives implanted contraceptives intrauterine devices Effective methods of contraception include, but are not limited to: diaphragms and cervical caps with spermicide cervical sponges condoms with spermicide NOTE: Use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these barrier methods are combined. Barrier protection methods without concomitant use of a spermicide are not an effective or acceptable method of contraception. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), and withdrawal are not acceptable methods of contraception. Participants not of reproductive potential are eligible without requiring the use of a contraceptive method. Participant-reported history is acceptable documentation of surgical sterilization and menopause. Participants with pregnant partners should use condoms during vaginal intercourse through 90 days after investigational agent administration. Participants should refrain from sperm donation through 90 days after investigational agent administration. NOTE: Reproductive potential is defined as patients who have reached menarche, who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) ≥ 40 IU/ml or 24 consecutive months if an FSH is not available, who have not undergone surgical sterilization, who do not have other clinical condition that could induce amenorrhea, who are not taking medications such as oral contraceptives, hormones, gonadotropin releasing hormone, antiestrogens, selective estrogen receptor modulators (SERMs) or chemotherapy that could induce amenorrhea. Individuals with permanent infertility due to an alternate medical cause (e.g. Mullerian agenesis, androgen insensitivity), investigator discretion should be applied.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Lundgren, Prof.
Organizational Affiliation
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Neaton, Prof.
Organizational Affiliation
INSIGHT Statistical and Coordinating Centre, University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Community Regional Medical Center (Site 203-005), 2823 Fresno Street
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Keck Hospital of USC (Site 301-020), 1500 San Pablo Street
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco VAMC (Site 074-002), 4150 Clement St.
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Miami VAMC (Site 074-003), 1201 NW 16 Street
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland Medical Center (Site 301-019), 22 South Greene Street
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Baystate Medical Center (Site 201-001), 759 Chestnut Street
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Michigan (Site 205-001), 1500 East Medical Center Drive
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hennepin Healthcare (Site 027-001), 701 Park Avenue
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Mississippi Medical Center (Site 202-005), 2500 North State Street
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Duke University Hospital (Site 301-006), 2301 Erwin Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Virginia Health Systems (Site 301-021), 1215 Lee Street
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Harborview Medical Center (Site 208-001), 325 9th Avenue
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
West Virginia University (Site 301-023), One Medical Center Drive
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aalborg Hospital (Site 625-005), Hobrovej 18
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Righospitalet (Site 625-006), Blegdamsvej 9,
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46
City
Madrid
ZIP/Postal Code
28017
Country
Spain
Facility Name
Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33356051
Citation
ACTIV-3/TICO LY-CoV555 Study Group; Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen JU, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Ostergaard L, Chang CC, Davey VJ, Goodman A, Higgs ES, Murray DD, Murray TA, Paredes R, Parmar MKB, Phillips AN, Reilly C, Sharma S, Dewar RL, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. N Engl J Med. 2021 Mar 11;384(10):905-914. doi: 10.1056/NEJMoa2033130. Epub 2020 Dec 22.
Results Reference
result

Learn more about this trial

LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

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