AzTrials
AzTrials

COVID-19Phase 3NCT05780268

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

A Phase 3 study testing LY3819253 and Remdesivir in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 57 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
LY3819253 and Remdesivir
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
314 participants
Where
57 sitesin 4 countries
Study dates
5 Aug 2020to 1 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

57 sites in 4 countries.

57 sites in 4 countries

United States42 sites

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

    Ann Arbor, Michigan, 48109

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

    Atlanta, Georgia, 30322

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

    Aurora, Colorado, 80045

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

    Baltimore, Maryland, 21201

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

    Boston, Massachusetts, 02114

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

    Charlottesville, Virginia, 22903

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

    Cleveland, Ohio, 44111

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

    Cleveland, Ohio, 44195

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

    Dallas, Texas, 75235

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

    Dallas, Texas, 75246

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

    Denver, Colorado, 80204

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

    Detroit, Michigan, 48202

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

    Durham, North Carolina, 27710

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

    Fresno, California, 93701

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

    Garfield Heights, Ohio, 44125

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

    Houston, Texas, 77030

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

    Houston, Texas, 77030

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

    Jackson, Mississippi, 39216

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

    Lebanon, New Hampshire, 03756

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

    Lexington, Kentucky, 40536

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

    Los Angeles, California, 90033

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

    Miami, Florida, 33125

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

    Minneapolis, Minnesota, 55415

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

    Morgantown, West Virginia, 26506

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

    Murray, Utah, 84107

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

    Nashville, Tennessee, 37232

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

    New Orleans, Louisiana, 70121

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

    Portland, Oregon, 97239-3098

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

    Richmond, Virginia, 23298

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

    Salt Lake City, Utah, 84108

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

    San Francisco, California, 94115

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

    San Francisco, California, 94121

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

    San Francisco, California, 94143

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

    Seattle, Washington, 98104

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

    Seattle, Washington, 98195

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

    Springfield, Massachusetts, 01199

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

    Stanford, California, 94305

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

    The Bronx, New York, 10461

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

    The Bronx, New York, 10467

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

    Tucson, Arizona, 85719

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

    Washington D.C., District of Columbia, 20007

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

    Winston-Salem, North Carolina, 27157

Other trials in United States

Denmark8 sites

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

    Aalborg, 9000

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

    Aarhus N, 8200

  • Righospitalet (Site 625-006), Blegdamsvej 9,

    Copenhagen Ø, 2100

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

    Herlev, 2730

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

    Hillerød, 3400

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

    Hvidovre, 2650

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

    Kolding, 6000

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

    Odense, 5000

Other trials in Denmark

Spain6 sites

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

    Badalona, Barcelona, 08916

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

    Barcelona, 08003

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

    Barcelona, 08036

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

    Madrid, 28017

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

    Madrid, 28040

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

    Madrid, 28046

Other trials in Spain

Singapore1 site

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

    Singapore, 308433

Other trials in Singapore

About this study

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))

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.

Read the 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.

Conditions
COVID-19
Being tested
LY3819253, Placebo, Remdesivir
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
Medical subject headings
COVID-19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3819253Biological

    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

  • PlaceboBiological

    Commercially available 0.9% sodium chloride solution

  • RemdesivirBiological

    Also called Veklury

    Antiviral agent

Study groups in NCT05780268
Study groupRoleWhat they receive
LY3819253 plus SOCExperimental* 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
Receives: Biological: LY3819253; Biological: Remdesivir
Placebo plus SOCPlacebo 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
Receives: Biological: Placebo; Biological: Remdesivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through Day 90

  2. Number of Participants With an Ordinal Outcome on Day 5

    Ordinal outcome with 7 mutually exclusive categories

    Measured: Status on Day 5

Secondary outcomes (4)

  1. Number of Participants Who Died From All Causes

    All-cause mortality

    Measured: Through Day 90

  2. 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

    Measured: Through Day 5

  3. 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

    Measured: Through Day 28

  4. Number of Participants With a Safety Outcome Through Day 90

    Death, SAE, clinical organ failure, serious infections through Day 90

    Measured: Through Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start5 Aug 2020
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780268
Sponsor's protocol ID
014/ACTIV-3/H1
Status last verified
Dec 2023
First submitted
20 Mar 2023
Last updated
27 Dec 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 33356051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY3819253 and Remdesivir in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 57 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Denmark, Spain, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Sustained Recovery (time frame: Through Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05780268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in