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I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations.
Files, Daniel Clark; Matthay, Michael A; Calfee, Carolyn S; Aggarwal, Neil R; Asare, Adam L; Beitler, Jeremy R; Berger, Paul A; Burnham, Ellen L; Cimino, George; Coleman, Melissa H; Crippa, Alessio; Discacciati, Andrea; Gandotra, Sheetal; Gibbs, Kevin W; Henderson, Paul T; Ittner, Caroline A G; Jauregui, Alejandra; Khan, Kashif T; Koff, Jonathan L; Lang, Julie; LaRose, Mary; Levitt, Joe; Lu, Ruixiao; McKeehan, Jeffrey D; Meyer, Nuala J; Russell, Derek W; Thomas, Karl W; Eklund, Martin; Esserman, Laura J; Liu, Kathleen D.
Afiliación
  • Files DC; Pulmonary, Critical Care, Allergy and Immunology Division, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA Clark.Files@wakehealth.edu.
  • Matthay MA; University of California San Francisco, San Francisco, California, USA.
  • Calfee CS; University of California San Francisco, San Francisco, California, USA.
  • Aggarwal NR; University of Colorado Denver School of Medicine, Aurora, Colorado, USA.
  • Asare AL; Quantum Leap Healthcare Collaborative, San Francisco, California, USA.
  • Beitler JR; Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University, New York City, New York, USA.
  • Berger PA; Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, USA.
  • Burnham EL; University of Colorado Denver School of Medicine, Aurora, Colorado, USA.
  • Cimino G; Quantum Leap Healthcare Collaborative, Fremont, California, USA.
  • Coleman MH; University of California San Francisco, San Francisco, California, USA.
  • Crippa A; Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Stockholm, Sweden.
  • Discacciati A; Karolinska Institute, Stockholm, Stockholm, Sweden.
  • Gandotra S; Pulmonary, Allergy, Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Gibbs KW; Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Henderson PT; Quantum Leap Healthcare Collaborative, San Francisco, California, USA.
  • Ittner CAG; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
  • Jauregui A; University of California San Francisco, San Francisco, California, USA.
  • Khan KT; University of Southern California, Los Angeles, California, USA.
  • Koff JL; Yale School of Medicine, New Haven, Connecticut, USA.
  • Lang J; University of Southern California, Los Angeles, California, USA.
  • LaRose M; Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Levitt J; Stanford University, Stanford, California, USA.
  • Lu R; Quantum Leap Healthcare Collaborative, Fremont, California, USA.
  • McKeehan JD; University of Colorado, Denver, Colorado, USA.
  • Meyer NJ; Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • Russell DW; Division of Pulmonary, Allergy, & Critical Care Medicine, The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.
  • Thomas KW; Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
  • Eklund M; Karolinska Institutet, Stockholm, Sweden.
  • Esserman LJ; University of California San Francisco, San Francisco, California, USA.
  • Liu KD; Nephrology, University of California San Francisco, San Francisco, California, USA.
BMJ Open ; 12(6): e060664, 2022 06 06.
Article en En | MEDLINE | ID: mdl-35667714
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome de Dificultad Respiratoria / Insuficiencia Respiratoria / COVID-19 Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome de Dificultad Respiratoria / Insuficiencia Respiratoria / COVID-19 Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido