I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations
Introduction The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and imple...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e060664.full |
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| author | Carolyn S Calfee Michael A Matthay Paul Henderson Martin Eklund Laura J Esserman Chirag Patel Angela Haczku Michelle Jung Tony Oliver Alessio Crippa Andrea Discacciati Kathleen D Liu Ellen L Burnham Nuala J Meyer Fady A Youssef Derek W Russell Julie Lang Kevin W Gibbs Daniel C Files Sheetal Gandotra Purnema Madahar Nathan K Cobb Timothy E Albertson Rajiv Sonti John P Reilly Alejandra Jauregui Iván García Luis E Huerta Daniel Clark Files Neil R Aggarwal Adam L Asare Jeremy R Beitler Paul A Berger George Cimino Melissa H Coleman Paul T Henderson Caroline A G Ittner Kashif T Khan Jonathan L Koff Mary LaRose Joe Levitt Ruixiao Lu Jeffrey D McKeehan Karl W Thomas Aaron M Mittel Albert F Yen Alexis E Suarez Alexis L Serra Alpesh N Amin Amanda Rosen Amy L Dzierba Anna D Barker Ariel R Weisman Brian M Daniel Brian M Morrissey Caroline AG Ittner Chayse Jones Christina Creel-Bulos Christina M Angelucci Diana Ng Fredy Chaparro-Rojas Gavin H Harris Harsh V Barot Heny Su Jacqueline B Sutter Jamal Dodin Jerry S Lee John Kazianis Joshua F Detelich Julie E Lang Justin Muir Katarzyna Gosek Katherine L Nugent Kimberly Yee Laura G Rodrigues Laura R Macias Lindsey A Orr Lindsie L Boerger Lissette Rosario-Remigio Lucia Kufa Maged Tanios Maria B Reyes Max W Adelman Maya M Juarez Michelle Meyers Mitchell P Sternlieb Neil Aggarwal Nilam S Mangalmurti Patrice Jones Paul L Saban Peter S Marshall Philiip A Robinson Philip Yang Rahul Nair Richard Anthony Lee Richard G Wunderink Romina Wahab Roxana A Lupu Santhi I Kumar Sara C Auld Scott Fields Se Fum Wong Skyler J Pearson Spencer Whealon Timothy F Obermiller Anita Darmanian John Schicchi Esmeralda Martinez Farjad Sarafian Julie Nguyen Bethany Weiler-Lisowski Jaime Wyatt Daniel Blevins Marylee Melendrez Brenda Lopez Hiwet Tzehaie Omowunmi Amosu Austin Simonson Erin Hardy Brett Lindgren Gregory Peterfreund Leigha Landreth Lisa Parks |
| author_facet | Carolyn S Calfee Michael A Matthay Paul Henderson Martin Eklund Laura J Esserman Chirag Patel Angela Haczku Michelle Jung Tony Oliver Alessio Crippa Andrea Discacciati Kathleen D Liu Ellen L Burnham Nuala J Meyer Fady A Youssef Derek W Russell Julie Lang Kevin W Gibbs Daniel C Files Sheetal Gandotra Purnema Madahar Nathan K Cobb Timothy E Albertson Rajiv Sonti John P Reilly Alejandra Jauregui Iván García Luis E Huerta Daniel Clark Files Neil R Aggarwal Adam L Asare Jeremy R Beitler Paul A Berger George Cimino Melissa H Coleman Paul T Henderson Caroline A G Ittner Kashif T Khan Jonathan L Koff Mary LaRose Joe Levitt Ruixiao Lu Jeffrey D McKeehan Karl W Thomas Aaron M Mittel Albert F Yen Alexis E Suarez Alexis L Serra Alpesh N Amin Amanda Rosen Amy L Dzierba Anna D Barker Ariel R Weisman Brian M Daniel Brian M Morrissey Caroline AG Ittner Chayse Jones Christina Creel-Bulos Christina M Angelucci Diana Ng Fredy Chaparro-Rojas Gavin H Harris Harsh V Barot Heny Su Jacqueline B Sutter Jamal Dodin Jerry S Lee John Kazianis Joshua F Detelich Julie E Lang Justin Muir Katarzyna Gosek Katherine L Nugent Kimberly Yee Laura G Rodrigues Laura R Macias Lindsey A Orr Lindsie L Boerger Lissette Rosario-Remigio Lucia Kufa Maged Tanios Maria B Reyes Max W Adelman Maya M Juarez Michelle Meyers Mitchell P Sternlieb Neil Aggarwal Nilam S Mangalmurti Patrice Jones Paul L Saban Peter S Marshall Philiip A Robinson Philip Yang Rahul Nair Richard Anthony Lee Richard G Wunderink Romina Wahab Roxana A Lupu Santhi I Kumar Sara C Auld Scott Fields Se Fum Wong Skyler J Pearson Spencer Whealon Timothy F Obermiller Anita Darmanian John Schicchi Esmeralda Martinez Farjad Sarafian Julie Nguyen Bethany Weiler-Lisowski Jaime Wyatt Daniel Blevins Marylee Melendrez Brenda Lopez Hiwet Tzehaie Omowunmi Amosu Austin Simonson Erin Hardy Brett Lindgren Gregory Peterfreund Leigha Landreth Lisa Parks |
| collection | DOAJ |
| description | Introduction The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.Methods and analysis The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.Ethics and dissemination ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.Trial registration number NCT04488081. |
| format | Article |
| id | doaj-art-480eafc2c901401aa40873075dcf1eb8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-480eafc2c901401aa40873075dcf1eb82025-01-27T17:30:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-060664I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations 0Carolyn S Calfee1Michael A Matthay2Paul Henderson3Martin Eklund4Laura J Esserman5Chirag Patel6Angela HaczkuMichelle Jung7Tony OliverAlessio Crippa8Andrea Discacciati9Kathleen D Liu10Ellen L Burnham11Nuala J Meyer12Fady A Youssef13Derek W Russell14Julie Lang15Kevin W Gibbs16Daniel C FilesSheetal Gandotra17Purnema MadaharNathan K CobbTimothy E AlbertsonRajiv SontiJohn P ReillyAlejandra Jauregui18Iván GarcíaLuis E HuertaDaniel Clark Files19Neil R Aggarwal20Adam L Asare21Jeremy R Beitler22Paul A Berger23George Cimino24Melissa H Coleman25Paul T Henderson26Caroline A G Ittner27Kashif T Khan28Jonathan L Koff29Mary LaRose30Joe Levitt31Ruixiao Lu32Jeffrey D McKeehan33Karl W Thomas34Aaron M MittelAlbert F YenAlexis E SuarezAlexis L SerraAlpesh N AminAmanda RosenAmy L DzierbaAnna D BarkerAriel R WeismanBrian M DanielBrian M MorrisseyCaroline AG IttnerChayse JonesChristina Creel-BulosChristina M AngelucciDiana NgFredy Chaparro-RojasGavin H HarrisHarsh V BarotHeny SuJacqueline B SutterJamal DodinJerry S LeeJohn KazianisJoshua F DetelichJulie E LangJustin MuirKatarzyna GosekKatherine L NugentKimberly YeeLaura G RodriguesLaura R MaciasLindsey A OrrLindsie L BoergerLissette Rosario-RemigioLucia KufaMaged Tanios35Maria B ReyesMax W AdelmanMaya M JuarezMichelle MeyersMitchell P SternliebNeil Aggarwal36Nilam S MangalmurtiPatrice JonesPaul L SabanPeter S MarshallPhiliip A RobinsonPhilip YangRahul NairRichard Anthony LeeRichard G WunderinkRomina WahabRoxana A LupuSanthi I KumarSara C Auld37Scott Fields38Se Fum WongSkyler J PearsonSpencer WhealonTimothy F ObermillerAnita DarmanianJohn SchicchiEsmeralda MartinezFarjad SarafianJulie Nguyen39Bethany Weiler-LisowskiJaime WyattDaniel BlevinsMarylee MelendrezBrenda LopezHiwet TzehaieOmowunmi AmosuAustin SimonsonErin HardyBrett LindgrenGregory PeterfreundLeigha LandrethLisa Parkspharmacologistintensive care physicianUniversity of California San Francisco, San Francisco, California, USADepartment of Paediatric Gastroenterology and Nutrition, Royal Hospital for Children and Young People, Edinburgh, UK3 Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, SwedenUniversity of California San Francisco, San Francisco, California, USADepartment of Biomedical Informatics, Harvard Medical School, Boston, Massachusetts, USADivision of Rheumatology, Department of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden3 Institute of Environmental Medicine, Karolinska Institute, Stockholm, SwedenDepartment of Medicine, Division of Nephrology, School of Medicine, University of California San Francisco, San Francisco, California, USADivision of Pulmonary and Critical Care Medicine, University of Colorado, Aurora, Colorado, USAMedicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USADepartment of Medicine, Division of Critical Care Medicine, MemorialCare - Long Beach Medical Center, Long Beach, California, USADepartment of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USAUniversity of Southern California, Los Angeles, California, USADepartment of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USADepartment of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA11 Department of Physical Activity and Healthy Lifestyles, National Institute of Public Health, Cuernavaca, MexicoPulmonary, Critical Care, Allergy and Immunology Division, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USAUniversity of Colorado Denver School of Medicine, Aurora, Colorado, USAQuantum Leap Healthcare Collaborative, San Francisco, California, USADivision of Pulmonary, Allergy, and Critical Care Medicine, Columbia University, New York City, New York, USASanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, USAQuantum Leap Healthcare Collaborative, Fremont, California, USAUniversity of California San Francisco, San Francisco, California, USAQuantum Leap Healthcare Collaborative, San Francisco, California, USAUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USAUniversity of Southern California, Los Angeles, California, USAYale School of Medicine, New Haven, Connecticut, USADepartment of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USAStanford University, Stanford, California, USAQuantum Leap Healthcare Collaborative, Fremont, California, USAUniversity of Colorado, Denver, Colorado, USADepartment of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USALong Beach Memorial Medical Center, Long Beach, California, USANew York State Psychiatric Institute, Columbia University, New York, New York, USADivision of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA3 Investigational Drug Pharmacy, University of California San Francisco, San Francisco, California, USAJuravinski Cancer Centre, Gynecologic Oncology, Hamilton, CanadaIntroduction The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.Methods and analysis The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.Ethics and dissemination ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.Trial registration number NCT04488081.https://bmjopen.bmj.com/content/12/6/e060664.full |
| spellingShingle | Carolyn S Calfee Michael A Matthay Paul Henderson Martin Eklund Laura J Esserman Chirag Patel Angela Haczku Michelle Jung Tony Oliver Alessio Crippa Andrea Discacciati Kathleen D Liu Ellen L Burnham Nuala J Meyer Fady A Youssef Derek W Russell Julie Lang Kevin W Gibbs Daniel C Files Sheetal Gandotra Purnema Madahar Nathan K Cobb Timothy E Albertson Rajiv Sonti John P Reilly Alejandra Jauregui Iván García Luis E Huerta Daniel Clark Files Neil R Aggarwal Adam L Asare Jeremy R Beitler Paul A Berger George Cimino Melissa H Coleman Paul T Henderson Caroline A G Ittner Kashif T Khan Jonathan L Koff Mary LaRose Joe Levitt Ruixiao Lu Jeffrey D McKeehan Karl W Thomas Aaron M Mittel Albert F Yen Alexis E Suarez Alexis L Serra Alpesh N Amin Amanda Rosen Amy L Dzierba Anna D Barker Ariel R Weisman Brian M Daniel Brian M Morrissey Caroline AG Ittner Chayse Jones Christina Creel-Bulos Christina M Angelucci Diana Ng Fredy Chaparro-Rojas Gavin H Harris Harsh V Barot Heny Su Jacqueline B Sutter Jamal Dodin Jerry S Lee John Kazianis Joshua F Detelich Julie E Lang Justin Muir Katarzyna Gosek Katherine L Nugent Kimberly Yee Laura G Rodrigues Laura R Macias Lindsey A Orr Lindsie L Boerger Lissette Rosario-Remigio Lucia Kufa Maged Tanios Maria B Reyes Max W Adelman Maya M Juarez Michelle Meyers Mitchell P Sternlieb Neil Aggarwal Nilam S Mangalmurti Patrice Jones Paul L Saban Peter S Marshall Philiip A Robinson Philip Yang Rahul Nair Richard Anthony Lee Richard G Wunderink Romina Wahab Roxana A Lupu Santhi I Kumar Sara C Auld Scott Fields Se Fum Wong Skyler J Pearson Spencer Whealon Timothy F Obermiller Anita Darmanian John Schicchi Esmeralda Martinez Farjad Sarafian Julie Nguyen Bethany Weiler-Lisowski Jaime Wyatt Daniel Blevins Marylee Melendrez Brenda Lopez Hiwet Tzehaie Omowunmi Amosu Austin Simonson Erin Hardy Brett Lindgren Gregory Peterfreund Leigha Landreth Lisa Parks I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations BMJ Open |
| title | I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations |
| title_full | I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations |
| title_fullStr | I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations |
| title_full_unstemmed | I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations |
| title_short | I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations |
| title_sort | i spy covid adaptive platform trial for covid 19 acute respiratory failure rationale design and operations |
| url | https://bmjopen.bmj.com/content/12/6/e060664.full |
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