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

PHASE3CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

August 5, 2020

Primary Completion Date

February 1, 2021

Study Completion Date

February 1, 2021

Conditions
COVID-19
Interventions
BIOLOGICAL

LY3819253

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

BIOLOGICAL

Placebo

Commercially available 0.9% sodium chloride solution

BIOLOGICAL

Remdesivir

Antiviral agent

Trial Locations (57)

2100

Righospitalet (Site 625-006), Blegdamsvej 9,, Copenhagen Ø

2650

Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30, Hvidovre

2730

Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75, Herlev

3400

Nordsjællands Hospital (Site 625-009), Dyrehavevej 29, Hillerød

5000

Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4, Odense

6000

Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24, Kolding

8200

Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99, Aarhus N

9000

Aalborg Hospital (Site 625-005), Hobrovej 18, Aalborg

10461

Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road, The Bronx

10467

Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street, The Bronx

20007

MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW, Washington D.C.

21201

University of Maryland Medical Center (Site 301-019), 22 South Greene Street, Baltimore

22903

University of Virginia Health Systems (Site 301-021), 1215 Lee Street, Charlottesville

23298

Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street, Richmond

26506

West Virginia University (Site 301-023), One Medical Center Drive, Morgantown

27157

Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd, Winston-Salem

27710

Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham

28017

Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46, Madrid

28040

Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN, Madrid

28046

UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal, Madrid

30322

Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE, Atlanta

33125

Miami VAMC (Site 074-003), 1201 NW 16 Street, Miami

37232

Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive, Nashville

39216

University of Mississippi Medical Center (Site 202-005), 2500 North State Street, Jackson

40536

University of Kentucky Hospital (Site 210-004), 1000 South Limestone St., Lexington

44111

Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue, Cleveland

44125

Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road, Garfield Heights

44195

Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue, Cleveland

48109

University of Michigan (Site 205-001), 1500 East Medical Center Drive, Ann Arbor

48202

Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd., Detroit

55415

Hennepin Healthcare (Site 027-001), 701 Park Avenue, Minneapolis

70121

Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway, New Orleans

75235

UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor, Dallas

75246

Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave., Dallas

77030

Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street, Houston

Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd., Houston

80045

University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue, Aurora

80204

Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic), Denver

84107

Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street, Murray

84108

University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207, Salt Lake City

85719

Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue, Tucson

90033

Keck Hospital of USC (Site 301-020), 1500 San Pablo Street, Los Angeles

93701

Community Regional Medical Center (Site 203-005), 2823 Fresno Street, Fresno

94115

UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St., San Francisco

94121

San Francisco VAMC (Site 074-002), 4150 Clement St., San Francisco

94143

UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave., San Francisco

94305

Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr., Stanford

98104

Harborview Medical Center (Site 208-001), 325 9th Avenue, Seattle

98195

University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street, Seattle

308433

Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng, Singapore

02114

Massachusetts General Hospital (Site 202-002), 55 Fruit Street, Boston

01199

Baystate Medical Center (Site 201-001), 759 Chestnut Street, Springfield

03756

Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive, Lebanon

97239-3098

Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd., Portland

08916

Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n, Badalona

08003

Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29, Barcelona

08036

Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170, Barcelona

All Listed Sponsors
collaborator

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

NETWORK

collaborator

University of Copenhagen

OTHER

collaborator

Medical Research Council

OTHER_GOV

collaborator

Kirby Institute

OTHER_GOV

collaborator

Washington D.C. Veterans Affairs Medical Center

FED

collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

US Department of Veterans Affairs

FED

collaborator

Prevention and Early Treatment of Acute Lung Injury

OTHER

collaborator

Cardiothoracic Surgical Trials Network

OTHER

collaborator

Eli Lilly and Company

INDUSTRY

collaborator

University of Minnesota

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT05780268 - LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) | Biotech Hunter | Biotech Hunter