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

NCT05780268 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 014/ACTIV-3/H1
• Study Type: interventional
• Target: 314
• Locations: 4 countries
• Sites: 57

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Through Day 90

• Number of Participants With an Ordinal Outcome on Day 5

  Ordinal outcome with 7 mutually exclusive categories

  Status on Day 5

Secondary Outcomes (4)

• Number of Participants Who Died From All Causes

  Through Day 90

• Number of Participants With a Safety Outcome Through Day 5

  Through Day 5

• Number of Participants With a Safety Outcome Through Day 28

  Through Day 28

• Number of Participants With a Safety Outcome Through Day 90

  Through Day 90

Study Arms (2)

LY3819253 plus SOC

EXPERIMENTAL

* 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

Biological: LY3819253; Biological: Remdesivir

Placebo plus SOC

PLACEBO COMPARATOR

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

Biological: Placebo; Biological: Remdesivir

Interventions

LY3819253 BIOLOGICAL

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

LY3819253 plus SOC

Placebo BIOLOGICAL

Commercially available 0.9% sodium chloride solution

Placebo plus SOC

Remdesivir BIOLOGICAL

Antiviral agent

Also known as: Veklury

LY3819253 plus SOC; Placebo plus SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• International Network for Strategic Initiatives in Global HIV Trials (INSIGHT): collaborator
• University of Copenhagen: collaborator
• Medical Research Council: collaborator
• Kirby Institute: collaborator
• Washington D.C. Veterans Affairs Medical Center: collaborator
• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• US Department of Veterans Affairs: collaborator
• Prevention and Early Treatment of Acute Lung Injury: collaborator
• Cardiothoracic Surgical Trials Network: collaborator
• Eli Lilly and Company: collaborator
• University of Minnesota: collaborator

Study Sites (57)

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

Tucson, Arizona, 85719, United States

Location

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

Fresno, California, 93701, United States

Location

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

Los Angeles, California, 90033, United States

Location

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

San Francisco, California, 94115, United States

Location

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

San Francisco, California, 94121, United States

Location

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

San Francisco, California, 94143, United States

Location

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

Stanford, California, 94305, United States

Location

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

Aurora, Colorado, 80045, United States

Location

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

Denver, Colorado, 80204, United States

Location

MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW

Washington D.C., District of Columbia, 20007, United States

Location

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

Miami, Florida, 33125, United States

Location

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

Atlanta, Georgia, 30322, United States

Location

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

Lexington, Kentucky, 40536, United States

Location

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

New Orleans, Louisiana, 70121, United States

Location

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

Baltimore, Maryland, 21201, United States

Location

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

Boston, Massachusetts, 02114, United States

Location

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

Springfield, Massachusetts, 01199, United States

Location

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

Ann Arbor, Michigan, 48109, United States

Location

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

Detroit, Michigan, 48202, United States

Location

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

Minneapolis, Minnesota, 55415, United States

Location

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

Jackson, Mississippi, 39216, United States

Location

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

Lebanon, New Hampshire, 03756, United States

Location

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

The Bronx, New York, 10461, United States

Location

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

The Bronx, New York, 10467, United States

Location

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

Durham, North Carolina, 27710, United States

Location

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

Winston-Salem, North Carolina, 27157, United States

Location

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

Cleveland, Ohio, 44111, United States

Location

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

Cleveland, Ohio, 44195, United States

Location

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

Garfield Heights, Ohio, 44125, United States

Location

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

Portland, Oregon, 97239-3098, United States

Location

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

Nashville, Tennessee, 37232, United States

Location

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

Dallas, Texas, 75235, United States

Location

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

Dallas, Texas, 75246, United States

Location

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

Houston, Texas, 77030, United States

Location

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

Houston, Texas, 77030, United States

Location

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

Murray, Utah, 84107, United States

Location

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

Salt Lake City, Utah, 84108, United States

Location

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

Charlottesville, Virginia, 22903, United States

Location

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

Richmond, Virginia, 23298, United States

Location

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

Seattle, Washington, 98104, United States

Location

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

Seattle, Washington, 98195, United States

Location

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

Morgantown, West Virginia, 26506, United States

Location

Aalborg Hospital (Site 625-005), Hobrovej 18

Aalborg, 9000, Denmark

Location

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

Aarhus N, 8200, Denmark

Location

Righospitalet (Site 625-006), Blegdamsvej 9,

Copenhagen Ø, 2100, Denmark

Location

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

Herlev, 2730, Denmark

Location

Nordsjællands Hospital (Site 625-009), Dyrehavevej 29

Hillerød, 3400, Denmark

Location

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

Hvidovre, 2650, Denmark

Location

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

Kolding, 6000, Denmark

Location

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

Odense, 5000, Denmark

Location

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

Singapore, 308433, Singapore

Location

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

Badalona, Barcelona, 08916, Spain

Location

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

Barcelona, 08003, Spain

Location

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

Barcelona, 08036, Spain

Location

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

Madrid, 28017, Spain

Location

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

Madrid, 28040, Spain

Location

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

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 33356051 RESULT

MeSH Terms

Conditions

COVID-19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; Severe Acute Respiratory Syndrome

Interventions

bamlanivimab; remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Birgit Grund
• Organization: University of Minnesota

birgit@ccbr.umn.edu

612- 626-8622

Study Officials

• Jens Lundgren, Prof.

  INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen

  PRINCIPAL INVESTIGATOR

• James Neaton, Prof.

  INSIGHT Statistical and Data Management Center, University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 22, 2023
• Study Start: August 5, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 27, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-12

Locations

US (42); ES (6); DK (8); SG (1)