Uno studio di LY3819253 (LY-CoV555) e LY3832479 (LY-CoV016) in partecipanti con malattia COVID-19 da lieve a moderata

Uno studio randomizzato, in doppio cieco, controllato con placebo, di fase 2/3 per valutare l'efficacia e la sicurezza di LY3819253 e LY3832479 nei partecipanti con malattia COVID-19 da lieve a moderata

Sponsor

Lead Sponsor: Eli Lilly and Company

Collaboratore: AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.

Fonte Eli Lilly and Company
Breve riassunto

Lo scopo di questo studio è misurare l'efficacia di LY3819253 e LY3832479 contro virus che causa COVID-19. LY3819253 e LY3832479 verranno consegnati ai partecipanti con anticipo sintomi di COVID-19. Verranno prelevati campioni dalla parte posteriore del naso per determinare quanto virus è nel corpo in diversi momenti durante lo studio. La partecipazione potrebbe durare circa 12 settimane e includono una visita obbligatoria al sito di studio, con il resto delle valutazioni eseguita in casa o per telefono.

Stato generale Reclutamento
Data d'inizio 2020-06-17
Data di completamento 2022-06-24
Data di completamento principale 2020-09-20
Fase Fase 2 / Fase 3
Tipo di studio Interventistica
Il risultato principale
Misurare Lasso di tempo
Percentage of Participants Who Experience COVID-Related Hospitalization or Death from Any Cause Baseline through Day 29
Cambiamento dal basale al giorno 11 nella sindrome respiratoria acuta grave Coronavirus 2 (SARS-CoV-2) Carica virale Baseline, giorno 11
Percentuale di partecipanti con carica virale SARS-CoV-2 maggiore di una soglia prespecificata 7 ° giorno
Farmacocinetica (PK): area sotto la curva concentrazione-tempo da 0 a infinito (AUC0-inf) sia per LY3819253 che per LY3832479 Mediterraans diëet
Percentuale di partecipanti che sperimentano uno o più eventi avversi gravi SAE Mediterraans diëet
Esito secondario
Misurare Lasso di tempo
Change from Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled with Recent Symptoms Prior to Randomization Baseline, Day 11
Percentuale di partecipanti che dimostrano la risoluzione dei sintomi Giorno 11
Percentuale di partecipanti che dimostrano un miglioramento dei sintomi Giorno 11
Farmacocinetica (PK): concentrazione media di LY3819253 e LY3819253 in presenza di LY3832479 Giorno 29
PK: concentrazione media di LY3832479 in presenza di LY3819253 Giorno 29
Percentuale di partecipanti che hanno subito ospedalizzazione correlata a COVID, visita al pronto soccorso correlata a COVID o morte per qualsiasi causa Mediterraans diëet
Cambiamento dal basale al giorno 7 nella carica virale SARS-CoV-2 Baseline, giorno 7
Percentuale di partecipanti arruolati con sintomi recenti prima della randomizzazione che hanno subito ospedalizzazione correlata a COVID o decesso per qualsiasi causa Baseline fino al giorno 29
Tempo per la risoluzione sostenuta dei sintomi Baseline fino al giorno 29
Tempo per la clearance virale di SARS-CoV-2 Baseline fino al giorno 29
Iscrizione 3160
Condizione
Intervento

Tipo di intervento: Drug

Nome intervento: LY3819253

Descrizione: Administered IV or SQ

Tipo di intervento: Farmaco

Nome intervento: LY3832479

Descrizione: Somministrato IV o SQ

Etichetta del gruppo del braccio: LY3819253 + LY3832479

Tipo di intervento: Farmaco

Nome intervento: Placebo

Descrizione: Somministrato IV

Etichetta del gruppo del braccio: Placebo

Eleggibilità

Criteri:

Criterio di inclusione: - Al momento non sono ricoverati in ospedale (non applicabile ai partecipanti al braccio di trattamento 22). - Ha uno o più sintomi COVID-19 lievi o moderati: febbre, tosse, mal di gola, malessere, mal di testa, dolore muscolare, sintomi gastrointestinali o mancanza di respiro con sforzo (non applicabile ai partecipanti al braccio di trattamento 22). - Deve essere stato prelevato un campione per il test che conferma l'infezione virale non più di 3 giorni prima all'inizio dell'infusione del farmaco - Sono maschi o femmine, comprese le donne in gravidanza, che accettano il contraccettivo requisiti - Comprendere e accettare di rispettare le procedure di studio pianificate - Accetta la raccolta di tamponi rinofaringei e sangue venoso (non applicabile a partecipanti ai bracci di trattamento 20-21.) - Il partecipante o un rappresentante legalmente autorizzato fornisce il consenso informato firmato e / o il consenso SOLO per i partecipanti ai bracci di trattamento 7-9, 13-14 e 18-21 - Sono maggiori o uguali a (≥) 18 anni di età e devono soddisfare almeno uno dei seguenti al momento dello screening - Sono incinta - Hanno un'età ≥65 anni - Avere un indice di massa corporea (BMI) ≥35 - Ha una malattia renale cronica (CKD) - Ha il diabete di tipo 1 o di tipo 2 - Ha una malattia immunosoppressiva - stanno attualmente ricevendo un trattamento immunosoppressivo o - Hanno un'età ≥55 anni E hanno: - malattie cardiovascolari (CVD), OR - ipertensione, OR - broncopneumopatia cronica ostruttiva (BPCO) o altre malattie respiratorie croniche malattia - Hanno 12-17 anni (inclusi) E soddisfano almeno uno dei seguenti requisiti presso il tempo di screening - Sono incinta - Avere un indice di massa corporea (BMI) ≥85 ° percentile per età e sesso in base a Grafici di crescita CDC, https://www.cdc.gov/growthcharts/clinical_charts.htm - Ha l'anemia falciforme - Ha una cardiopatia congenita o acquisita - Ha disturbi del neurosviluppo, ad esempio, paralisi cerebrale - Avere una dipendenza tecnologica correlata alla medicina, ad esempio, tracheotomia, gastrostomia o ventilazione a pressione positiva (non correlata a COVID-19) - Ha l'asma o la reattività delle vie aeree o altre malattie respiratorie croniche che richiedono farmaci quotidiani per il controllo - Ha il diabete di tipo 1 o di tipo 2 - Ha una malattia renale cronica - Ha una malattia immunosoppressiva, o - Al momento stanno ricevendo un trattamento immunosoppressivo SOLO per i partecipanti al braccio di trattamento 22 - Sono da 0 (età gestazionale ≥ 32 settimane E ≥ 1,5 chilogrammi [kg]) a 17 anni di età (compreso) E soddisfare almeno uno dei seguenti fattori di rischio al momento dello screening - Sono incinta - Avere un BMI ≥85 ° percentile per la loro età e sesso sulla base dei grafici di crescita CDC, https://www.cdc.gov/growthcharts/clinical_charts.htm - Ha l'anemia falciforme - Ha una cardiopatia congenita o acquisita - Ha disturbi dello sviluppo neurologico, ad esempio, paralisi cerebrale, autismo o Down sindrome (FAIR Health 2020; Spreat et al.2020) - Avere una dipendenza tecnologica correlata alla medicina, ad esempio, tracheotomia, gastrostomia o ventilazione a pressione positiva (non correlata a COVID-19) - Ha l'asma, la fibrosi cistica, la malattia reattiva delle vie aeree o altre vie respiratorie croniche malattia che richiede farmaci quotidiani per il controllo - Ha il diabete di tipo 1 o di tipo 2 - Ha una malattia renale cronica - Ha una malattia immunosoppressiva, o - stanno attualmente ricevendo un trattamento immunosoppressivo, o - Sono inferiori a (

Genere:

Tutti

Età minima:

N / A

Età massima:

N / A

Volontari sani:

No

Ufficiale generale
Cognome Ruolo Affiliazione
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Contatto generale

Cognome: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Telefono: 1-317-615-4559

E-mail: [email protected]

Posizione
Servizio, struttura: Stato: Contatto: Investigatore:
University of Alabama at Birmingham | Birmingham, Alabama, 35233, United States Not yet recruiting 205-638-2530 David Kimberlin Principal Investigator
Arizona Clin Trials-Mesa | Mesa, Arizona, 85210, United States Recruiting 619-822-5941 Yessica Sachdeva Principal Investigator
Perseverance Research Center | Scottsdale, Arizona, 85254, United States Recruiting 480-471-6132 Kenneth Steil Principal Investigator
CRI of Arizona, LLC | Sun City West, Arizona, 85375, United States Recruiting 623-223-1580 Jalal Abbas Principal Investigator
Fiel Family and Sports Medicine PC | Tempe, Arizona, 85283, United States Recruiting 480-831-6328 Thomas Fiel Principal Investigator
Orange Grove Banner Clinic | Tucson, Arizona, 85704, United States Recruiting 520-626-2038 Jarrod Mosier Principal Investigator
Arizona Clin Trials-Tucson | Tucson, Arizona, 85712, United States Recruiting 434-825-0921 Anita Kohli Principal Investigator
KLR Business Group, Inc. dba Arkansas Clinical Research | Little Rock, Arkansas, 72205, United States Recruiting 501-907-9170 Kevin D Roberts Principal Investigator
Applied Rsch Ctr - Arkansas Inc. | Little Rock, Arkansas, 72212, United States Recruiting 501-954-7822 Lee Wilbur Principal Investigator
Smart Cures Clin Research | Anaheim, California, 92806, United States Recruiting Nader Sobh Principal Investigator
Hope Clinical Research | Canoga Park, California, 91303, United States Recruiting 818-999-4673 Hessam Aazami Principal Investigator
VCT-Covina | Covina, California, 91723, United States Recruiting 626-598-4952 Masoud Azizad Principal Investigator
AMCR Institute | Escondido, California, 92025, United States Recruiting 760-466-1530 Timothy S. Bailey Principal Investigator
Chemidox Clinical Trials | Lancaster, California, 93534, United States Recruiting 833-324-3643 Alon Antebi Principal Investigator
Ark Clinical Research | Long Beach, California, 90806, United States Recruiting 562-997-1000 Apinya Bee Vutikullird Principal Investigator
Long Beach Clinical Trials LLC | Long Beach, California, 90806, United States Recruiting 562-436-4761 Barry Heller Principal Investigator
Cedars Sinai Medical Center | Los Angeles, California, 90048-5615, United States Recruiting 424-315-2861 Peter Chen Principal Investigator
UCLA Mattel Children's Hospital | Los Angeles, California, 90095, United States Not yet recruiting 310-825-0825 Jaime DeVille Principal Investigator
Central Valley Research, LLC | Modesto, California, 95350, United States Recruiting 209-549-9538 Faisal Amin Principal Investigator
Catalina Research Institute, LLC | Montclair, California, 91763, United States Recruiting 909-590-8409 Rizwana H Mohseni Principal Investigator
University of CA, Irvine | Orange, California, 92868, United States Recruiting 714-456-5501 Donald Forthal Principal Investigator
Inland Empire Liver Foundation | Rialto, California, 92377, United States Recruiting 909-883-2999 Zeid Kayali Principal Investigator
Sutter Institute For Medical Research | Sacramento, California, 95816, United States Recruiting 916-478-6561 Aaron Kinney Principal Investigator
Zion Medical Center | San Diego, California, 92120, United States Completed
Kaiser Permanente - SD Med Ctr | San Diego, California, 92123, United States Completed
Wolverine Clinical Trials, LLC | Santa Ana, California, 92705, United States Recruiting 7146172426 Wayne Wei-Chin Chen Principal Investigator
St. Joe Heritage HC-Santa Rosa | Santa Rosa, California, 95405, United States Recruiting 707-890-4100 David Della Lana Principal Investigator
Stanford University Hospital | Stanford, California, 94305, United States Recruiting 650-723-9656 Andra Blomkalns Principal Investigator
Mazur, Statner, Dutta, Nathan | Thousand Oaks, California, 91360, United States Recruiting 310-890-2713 Ramesh Nathan Principal Investigator
South Bay Clinical Research Institute | Torrance, California, 90503, United States Recruiting 310-560-9964 Luis Abrishamian Principal Investigator
Infect Disease Doctors Med Grp | Walnut Creek, California, 94598, United States Recruiting 925-947-2334 Bhavna Malik Principal Investigator
Allianz Research Institute | Westminster, California, 92683, United States Recruiting 714-887-0400 David Pham Principal Investigator
Future Innovative Treatments LLC | Colorado Springs, Colorado, 80907, United States Recruiting 719-310-6719 Bhaktasharan Patel Principal Investigator
Georgetown Univ Sch of Med | Washington, District of Columbia, 20007, United States Recruiting 202-444-0086 Princy Kumar Principal Investigator
Synergy Healthcare LLC | Bradenton, Florida, 34208, United States Recruiting 941-896-4948 Patrick Weston Principal Investigator
Holy Cross Hospital Inc. | Fort Lauderdale, Florida, 33308, United States Recruiting 9542298400 Joshua Michael Purow Principal Investigator
I R & Health Center, Inc. | Hialeah, Florida, 33012, United States Recruiting 305-825-6588 Jose F Cardona Principal Investigator
Encore Medical Research | Hollywood, Florida, 33021, United States Recruiting 954-400-1725 Rodolfo Perez Principal Investigator
Elixia CRC | Hollywood, Florida, 33023, United States Recruiting 786-267-8166 Steven Zeig Principal Investigator
University of Florida Jacksonville | Jacksonville, Florida, 32209, United States Recruiting 904-798-4179 Mobeen Rathore Principal Investigator
Lakeland Regional Medical Center | Lakeland, Florida, 33805, United States Not yet recruiting 863-660-0188 James Melton Principal Investigator
Panax Clinical Research | Miami Lakes, Florida, 33014, United States Recruiting 305-698-4500 Robert Perry Principal Investigator
Hope Clinical Trials, Inc. | Miami, Florida, 33165, United States Not yet recruiting 786-464-0732 Jose Pinero Principal Investigator
Miami Cancer Institute at Baptist Health, Inc. | Miami, Florida, 33176, United States Recruiting 305-728-1848 Guenther Koehne Principal Investigator
Bio-Medical Research, LLC | Miami, Florida, 33184, United States Recruiting 305-671-3686 Lilia Roque-Guerrero Principal Investigator
Clinical Site Partners, LLC d/b/a CSP Miami | Miami, Florida, 33186, United States Not yet recruiting 352-266-2625 James Krainson Principal Investigator
GCPR | Saint Petersburg, Florida, 33705, United States Recruiting 727-520-1427 Roxana Stoici Principal Investigator
Testing Matters Lab | Sunrise, Florida, 33325, United States Recruiting 786-267-8166 Steven Zeig Principal Investigator
Advent Health Tampa | Tampa, Florida, 33613, United States Recruiting 813-610-8110 Elvis Castillo Principal Investigator
Triple O Research Inst | West Palm Beach, Florida, 33407, United States Recruiting 561-855-7871 Olayemi Osiyemi Principal Investigator
Encore Medical Research - Weston | Weston, Florida, 33331, United States Not yet recruiting 954-400-1725 Sandro Bacchelli Principal Investigator
Clinical Site Partners, LLC DBA CSP Orlando | Winter Park, Florida, 32789, United States Recruiting 407-740-8078 Faisal A Fakih Principal Investigator
Gwinnett Research Inst | Buford, Georgia, 30519, United States Recruiting 470-326-3358 Alexander E. Osowa Principal Investigator
Paramount Rch Sol - College Pk | College Park, Georgia, 30349, United States Recruiting 404-657-4500 Michelle Evans Principal Investigator
IACT Health - VHC | Columbus, Georgia, 31904, United States Recruiting 706-780-6389 Joseph Surber Principal Investigator
Central Georgia Infectious Disease | Macon, Georgia, 31201, United States Recruiting 478-741-5945 Quyen Luu Principal Investigator
Rophe Adult and Pediatric Medicine | Union City, Georgia, 30291, United States Recruiting 888-659-4363 Dwight D Blake Principal Investigator
Rocky Mountain Clinical Research | Idaho Falls, Idaho, 83404, United States Recruiting 208-522-6005 Carl D Vance Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago | Chicago, Illinois, 60611, United States Not yet recruiting 312-227-4834 William Muller Principal Investigator
Northwestern University | Chicago, Illinois, 60611, United States Completed
J H. Stroger Hosp of Cook Co | Chicago, Illinois, 60612, United States Recruiting 312-572-4575 Gregory Huhn Principal Investigator
University of Chi Med Center | Chicago, Illinois, 60637, United States Completed
Great Lakes Clinical Trials | Chicago, Illinois, 60640, United States Recruiting 773-275-3500 Yevgeniy Bukhman Principal Investigator
Franciscan Health Hammond | Dyer, Indiana, 46311, United States Completed
Qualmedica Research Evansville | Evansville, Indiana, 47715, United States Recruiting 812-205-2475 David Schultz Principal Investigator
Community Hospital South | Indianapolis, Indiana, 46227, United States Completed
Franciscan St. Francis Health | Indianapolis, Indiana, 46237, United States Recruiting 317-885-2860 Imad J Shawa Principal Investigator
St.Vincent - Indy | Indianapolis, Indiana, 46260, United States Recruiting 317-582-8180 Francisco Delgado Principal Investigator
University of Louisville | Louisville, Kentucky, 40202, United States Not yet recruiting 502-629-5820 Daniel Blatt Principal Investigator
Qualmedica Research, LLC | Owensboro, Kentucky, 42301, United States Recruiting 812-550-3197 Christopher Sartore Principal Investigator
Tandem Clinical Research,LLC | Marrero, Louisiana, 70072, United States Recruiting 504-934-8424 Adil Fatakia Principal Investigator
Imperial Health Urgent Care Center - Moss Bluff | Moss Bluff, Louisiana, 70611, United States Recruiting 337-602-6642 Jason Morris Principal Investigator
Nola Research Works, LLC | New Orleans, Louisiana, 70125, United States Recruiting 504-891-3613 Corey Hebert Principal Investigator
University of Maryland Medical Center | Baltimore, Maryland, 21201, United States Recruiting 4103287635 R. Gentry Wilkerson Principal Investigator
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States Recruiting 617-724-0195 Michael L Dougan Principal Investigator
U of MA Mem Med Ctr | Worcester, Massachusetts, 01605, United States Recruiting 508-334-1000 ROBERT FINBERG Principal Investigator
University of Michigan Health Systems | Ann Arbor, Michigan, 48109-5861, United States Recruiting 734-347-7482 Owen Albin Principal Investigator
Great Lakes Research Group, Inc. | Bay City, Michigan, 48706, United States Recruiting 989-895-9100 Jeffrey A. Potts Principal Investigator
Childrens Hospital of Michigan | Detroit, Michigan, 48201, United States Not yet recruiting 313-745-5515 Jocelyn Ang Principal Investigator
Henry Ford Hospital | Detroit, Michigan, 48202, United States Recruiting 313-623-2531 Mayur Ramesh Principal Investigator
Revive Research Institute | Farmington Hills, Michigan, 48334, United States Recruiting 248-564-1485 Barry Feldman Principal Investigator
Revival Research Institute | Sterling Heights, Michigan, 48312, United States Recruiting 248-721-9539 Abdulhassan Saad Principal Investigator
Sky Clinical Prime and Health Wellness Clinic | Fayette, Mississippi, 39069, United States Recruiting 601-786-8655 James B Hall Principal Investigator
Olive Branch Family Medical Center | Olive Branch, Mississippi, 38654, United States Recruiting 6628954949 Randall Toombs Huling Principal Investigator
Sky Clin Resch - Quinn HC | Ridgeland, Mississippi, 39157, United States Recruiting 601-487-6482 Timothy Quinn Principal Investigator
Bio-Kinetic Clinical Applications, LLC | Springfield, Missouri, 65802, United States Recruiting 417-893-6103 Kayce Morton Principal Investigator
Childrens Endocrine Clinic | Omaha, Nebraska, 68114, United States Not yet recruiting 402-559-2511 Russell McCulloh Principal Investigator
Quality Clinical Research | Omaha, Nebraska, 68114, United States Recruiting 402-934-0044 Michael J Dunn Principal Investigator
Excel Clinical Research | Las Vegas, Nevada, 89109, United States Recruiting 702-680-1500 Duane Anderson Principal Investigator
Las Vegas Medical Research | Las Vegas, Nevada, 89113, United States Recruiting 702-612-8127 Bharat R Mocherla Principal Investigator
SG Clinical Research - PC | Las Vegas, Nevada, 89128, United States Not yet recruiting 702-409-3770 Vijay Goli Principal Investigator
SG Clinical Research - PC | Las Vegas, Nevada, 89128, United States Not yet recruiting Vijay Goli Principal Investigator
Holy Name Medical Center | Teaneck, New Jersey, 07666, United States Recruiting 201-503-0660 Suraj Saggar Principal Investigator
Care Access Research - Bronx | Bronx, New York, 10456, United States Recruiting 718-530-0051 Rubaba Hussain Principal Investigator
Icahn Sch of Med at Mt. Sinai | New York, New York, 10029, United States Recruiting 646-818-9502 Jonathan Schimmel Principal Investigator
University of North Carolina | Chapel Hill, North Carolina, 27599, United States Recruiting 410-908-7779 William A Fischer Principal Investigator
OnSite Clinical Solutions | Charlotte, North Carolina, 28208, United States Not yet recruiting 800-785-3150 Arin Piramzadian Principal Investigator
East Carolina University | Greenville, North Carolina, 27834, United States Recruiting 252-744-0860 Paul P Cook Principal Investigator
Monroe Biomed Research | Monroe, North Carolina, 28112, United States Recruiting 704-283-7369 Awawu Igbinadolor Principal Investigator
Carteret Medical Group | Morehead City, North Carolina, 28557, United States Recruiting 2527279501 Mary Katherine Lawrence Principal Investigator
Carolina Research Center, Inc. | Shelby, North Carolina, 28150, United States Recruiting 705-787-5228 Stephen W Jones Principal Investigator
PMG Research of Wilmington | Wilmington, North Carolina, 28401, United States Recruiting 910-815-6108 Kevin D Cannon Principal Investigator
Valley Medical Primary Care | Centerville, Ohio, 45459, United States Not yet recruiting Meenakshi C Patel Principal Investigator
Hometown UC and Rch- Cincy | Cincinnati, Ohio, 45215, United States Recruiting 937-293-2157 Blaise Gatto Principal Investigator
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Recruiting 216-445-5429 Kristin Highland Principal Investigator
OH State Univ College of Med | Columbus, Ohio, 43210, United States Completed
Aventiv Research Inc | Columbus, Ohio, 43213, United States Recruiting 614-501-6164 Samir Arora Principal Investigator
Urgent Care Specialists, LLC | Columbus, Ohio, 43214, United States Recruiting 674-263-4400 Narinder Saini Principal Investigator
Remington-Davis, Inc | Columbus, Ohio, 43215, United States Recruiting 614-487-2560 Brian Zeno Principal Investigator
Urgent Care Specialists, LLC | Dayton, Ohio, 45424, United States Recruiting 937-912-4444 Steve Choi Principal Investigator
META Medical Research Institute, LLC | Dayton, Ohio, 45432, United States Recruiting 937-252-2000 Priyesh Mehta Principal Investigator
Ascension St. John Tulsa OK | Tulsa, Oklahoma, 74104, United States Recruiting 918-744-3426 Anuj Malik Principal Investigator
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 18901, United States Not yet recruiting 267-425-2133 Hamid Bassiri Principal Investigator
Jefferson Hosp for Neurosci | Philadelphia, Pennsylvania, 19107, United States Recruiting 215-955-2007 Katherine Belden Principal Investigator
Temple University Hospital | Philadelphia, Pennsylvania, 19140, United States Recruiting 215-707-1359 GERARD J CRINER Principal Investigator
VITALINK - Anderson | Anderson, South Carolina, 29621, United States Recruiting 864-965-0190 Charles Thompson Principal Investigator
Carolina Medical Research - Clinton | Clinton, South Carolina, 29325, United States Recruiting 864-547-1321 Nancy Patel Principal Investigator
VITALINK - Gaffney | Gaffney, South Carolina, 29340, United States Recruiting 864-488-1283 David Erb Principal Investigator
Carolina Medical Research - Greenville | Greenville, South Carolina, 29607, United States Recruiting 864-547-1321 Ravikumar Patel Principal Investigator
VITALINK - Greenville | Greenville, South Carolina, 29615, United States Recruiting 864-770-0890 Luis de la Cruz Principal Investigator
VITALINK - Spartanburg | Spartanburg, South Carolina, 29303, United States Recruiting 864-515-0092 Gregory Feldman Principal Investigator
VITALINK - Union | Union, South Carolina, 29379, United States Recruiting 864-427-1172 Joseph Boscia Principal Investigator
Univ Diab & Endo Consult | Chattanooga, Tennessee, 37411, United States Recruiting 423-265-3561 David Huffman Principal Investigator
New Phase Research and Development | Knoxville, Tennessee, 37909, United States Recruiting 865-200-8364 Evelyne M Davidson Principal Investigator
St Jude Childrens Research Hospital | Memphis, Tennessee, 38105, United States Not yet recruiting 901-595-0448 Diego Hijano Principal Investigator
Central Texas Clinical Rch | Austin, Texas, 78705, United States Recruiting 512-480-9660 Cynthia C Brinson Principal Investigator
Gadolin Research, LLC | Beaumont, Texas, 77702, United States Recruiting 409-331-6040 Russell Perry Principal Investigator
Conroe Willis Medical Research | Conroe, Texas, 77304, United States Recruiting 832-322-0177 Jeremy Laningham Principal Investigator
Driscoll Children's Hospital | Corpus Christi, Texas, 78411, United States Not yet recruiting 361-694-4864 Estela O'Daniell Principal Investigator
Crossroads Clinical Research | Corpus Christi, Texas, 78413, United States Recruiting 361-288-4668 Michael Winnie Principal Investigator
B S & W Med Center | Dallas, Texas, 75246, United States Recruiting 888-50-RESEARCH (73732724) Robert Gottlieb Principal Investigator
Baylor Scott & White Rsch Inst Dallas | Dallas, Texas, 75246, United States Not yet recruiting 888-50-RESEARCH (73732724) Robert Gottlieb Principal Investigator
Baylor - Fort Worth | Fort Worth, Texas, 76104, United States Recruiting 888-50-RESEARCH (73732724) Robert Gottlieb Principal Investigator
North Texas Clinical Trials, LLC | Fort Worth, Texas, 76104, United States Recruiting 817-744-8844 James Winn Principal Investigator
Houston Methodist Research Ins | Houston, Texas, 77030, United States Recruiting 713-441-9793 Howard Huang Principal Investigator
Next Level Urgent Care | Houston, Texas, 77057, United States Recruiting 832-460-3311 Wilner E. Jeudy Principal Investigator
Centex-Houston | Houston, Texas, 77058, United States Recruiting 281-282-0808 Joe Pouzar Principal Investigator
Accurate Clinical Management, LLC. | Houston, Texas, 77065, United States Not yet recruiting 713-377-6433 Aramis Cosme Principal Investigator
BioPharma Clinc Site | Houston, Texas, 77090, United States Recruiting 832-818-8115 Victor Escobar Principal Investigator
Centex-Wesfield | Houston, Texas, 77090, United States Recruiting 281-786-1660 Ali Bajwa Principal Investigator
B S & W Med Center | Irving, Texas, 75061, United States Recruiting 888-50-RESEARCH (73732724) Robert Gottlieb Principal Investigator
Zion Urgent Care Clinic | Katy, Texas, 77494, United States Not yet recruiting 832-770-1951 Tewodros Teketel Principal Investigator
BioPharma Family Practice Center McAllen | McAllen, Texas, 78501, United States Recruiting 956-668-0044 Manuel Sanchez Principal Investigator
BRCR Medical Center, Inc | McAllen, Texas, 78501, United States Recruiting 561-447-0614 Roman Tavarez Principal Investigator
North Hills Medical Research | North Richland Hills, Texas, 76180, United States Recruiting 817-595-3399 John Gabriel Principal Investigator
Bay Area Infectious Diseases Associates | Pasadena, Texas, 77505, United States Recruiting 281-991-7999 Zaher Shebib Principal Investigator
Epic Medical Research | Red Oak, Texas, 75154, United States Not yet recruiting 972-777-6956 Haresh Boghara Principal Investigator
Baylor - Round Rock | Round Rock, Texas, 78665, United States Recruiting 888-50-RESEARCH (73732724) Robert Gottlieb Principal Investigator
Sun Research Institute | San Antonio, Texas, 78215, United States Recruiting 210-277-1289 Carl Dukes Principal Investigator
Consano Clinical Research, LLC | Shavano Park, Texas, 78231, United States Recruiting 210-545-4900 Michelle Welch Principal Investigator
APD Clinical Research | Splendora, Texas, 77372, United States Recruiting 281-370-7272 Najmuddin Karimjee Principal Investigator
Baylor Scott and White Medical Center | Temple, Texas, 76502, United States Not yet recruiting 888-50-RESEARCH (73732724) Robert Gottlieb Principal Investigator
Crossroads Clin Rch-Victoria | Victoria, Texas, 77901, United States Recruiting 361-574-7800 Omesh Verma Principal Investigator
CLS Research Ctr, PLLC | Webster, Texas, 77598, United States Recruiting 281-724-8180 Husam Issa Principal Investigator
CARE ID | Annandale, Virginia, 22003, United States Recruiting 703-560-4821 David Wheeler Principal Investigator
Evergreen Health Research | Kirkland, Washington, 98034, United States Recruiting 512-751-5496 Chad Crystal Principal Investigator
Advanced Clinical Research, LLC | Bayamon, 00961, Puerto Rico Recruiting 7872696590 Angel Luis Comulada-Rivera Principal Investigator
Dorado Medical Complex Inc | Dorado, 00646, Puerto Rico Recruiting 7872781576 Luis A Pagan-Cardona Principal Investigator
GCM Medical Group, PSC - Hato Rey Site | San Juan, 00917, Puerto Rico Recruiting 7879362100 Gregorio A. Cortes-Maisonet Principal Investigator
Paesi di posizione

Puerto Rico

United States

Data di verifica

2021-05-01

Parte responsabile

Genere: Sponsor

Ha accesso esteso No
Numero di armi 3
Braccio di gruppo

Etichetta: LY3819253

Genere: Experimental

Descrizione: LY3819253 administered intravenously (IV)

Etichetta: LY3819253 + LY3832479

Genere: Sperimentale

Descrizione: LY3819253 + LY3832479 somministrato per via endovenosa o sottocutanea (SQ)

Etichetta: Placebo

Genere: Comparatore di placebo

Descrizione: Placebo somministrato per via endovenosa

Acronimo BLAZE-1
Informazioni sul design dello studio

Assegnazione: Randomizzato

Modello di intervento: Assegnazione sequenziale

Scopo principale: Trattamento

Mascheramento: Doppio (partecipante, investigatore)

Descrizione del mascheramento: Alcuni bracci di trattamento sono in aperto.

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