COVID-19 Clinical 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))
Verified date | December 2023 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 314 |
Est. completion date | February 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg Hospital (Site 625-005), Hobrovej 18 | Aalborg | |
Denmark | Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99 | Aarhus N | |
Denmark | Righospitalet (Site 625-006), Blegdamsvej 9, | Copenhagen Ø | |
Denmark | Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75 | Herlev | |
Denmark | Nordsjællands Hospital (Site 625-009), Dyrehavevej 29 | Hillerød | |
Denmark | Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30 | Hvidovre | |
Denmark | Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24 | Kolding | |
Denmark | Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4 | Odense | |
Singapore | Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng | Singapore | |
Spain | Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n | Badalona | Barcelona |
Spain | Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170 | Barcelona | |
Spain | Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29 | Barcelona | |
Spain | Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN | Madrid | |
Spain | Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46 | Madrid | |
Spain | UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal | Madrid | |
United States | University of Michigan (Site 205-001), 1500 East Medical Center Drive | Ann Arbor | Michigan |
United States | Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE | Atlanta | Georgia |
United States | University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue | Aurora | Colorado |
United States | University of Maryland Medical Center (Site 301-019), 22 South Greene Street | Baltimore | Maryland |
United States | Massachusetts General Hospital (Site 202-002), 55 Fruit Street | Boston | Massachusetts |
United States | Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street | Bronx | New York |
United States | Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road | Bronx | New York |
United States | University of Virginia Health Systems (Site 301-021), 1215 Lee Street | Charlottesville | Virginia |
United States | Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue | Cleveland | Ohio |
United States | Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue | Cleveland | Ohio |
United States | Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave. | Dallas | Texas |
United States | UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor | Dallas | Texas |
United States | Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic) | Denver | Colorado |
United States | Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd. | Detroit | Michigan |
United States | Duke University Hospital (Site 301-006), 2301 Erwin Road | Durham | North Carolina |
United States | Community Regional Medical Center (Site 203-005), 2823 Fresno Street | Fresno | California |
United States | Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road | Garfield Heights | Ohio |
United States | Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street | Houston | Texas |
United States | Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd. | Houston | Texas |
United States | University of Mississippi Medical Center (Site 202-005), 2500 North State Street | Jackson | Mississippi |
United States | Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive | Lebanon | New Hampshire |
United States | University of Kentucky Hospital (Site 210-004), 1000 South Limestone St. | Lexington | Kentucky |
United States | Keck Hospital of USC (Site 301-020), 1500 San Pablo Street | Los Angeles | California |
United States | Miami VAMC (Site 074-003), 1201 NW 16 Street | Miami | Florida |
United States | Hennepin Healthcare (Site 027-001), 701 Park Avenue | Minneapolis | Minnesota |
United States | West Virginia University (Site 301-023), One Medical Center Drive | Morgantown | West Virginia |
United States | Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street | Murray | Utah |
United States | Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive | Nashville | Tennessee |
United States | Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway | New Orleans | Louisiana |
United States | Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd. | Portland | Oregon |
United States | Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street | Richmond | Virginia |
United States | University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207 | Salt Lake City | Utah |
United States | San Francisco VAMC (Site 074-002), 4150 Clement St. | San Francisco | California |
United States | UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave. | San Francisco | California |
United States | UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St. | San Francisco | California |
United States | Harborview Medical Center (Site 208-001), 325 9th Avenue | Seattle | Washington |
United States | University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street | Seattle | Washington |
United States | Baystate Medical Center (Site 201-001), 759 Chestnut Street | Springfield | Massachusetts |
United States | Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr. | Stanford | California |
United States | Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue | Tucson | Arizona |
United States | MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW | Washington | District of Columbia |
United States | Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | AIDS Clinical Trials Group, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), Kirby Institute, Medical Research Council, National Heart, Lung, and Blood Institute (NHLBI), Prevention and Early Treatment of Acute Lung Injury, University of Copenhagen, University of Minnesota, US Department of Veterans Affairs, Washington D.C. Veterans Affairs Medical Center |
United States, Denmark, Singapore, Spain,
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, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Number of Participants With an Ordinal Outcome on Day 5 | Ordinal outcome with 7 mutually exclusive categories | Status on Day 5 | |
Secondary | Number of Participants Who Died From All Causes | All-cause mortality | Through Day 90 | |
Secondary | 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 | Through Day 5 | |
Secondary | 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 | Through Day 28 | |
Secondary | Number of Participants With a Safety Outcome Through Day 90 | Death, SAE, clinical organ failure, serious infections through Day 90 | Through Day 90 |
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---|---|---|---|
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