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I-SPY COVID adaptiv...
I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations
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Files, DC (författare)
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Matthay, MA (författare)
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Calfee, CS (författare)
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visa fler...
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Aggarwal, NR (författare)
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Asare, AL (författare)
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Beitler, JR (författare)
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Berger, PA (författare)
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Burnham, EL (författare)
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Cimino, G (författare)
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Coleman, MH (författare)
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- Crippa, A (författare)
- Karolinska Institutet
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- Discacciati, A (författare)
- Karolinska Institutet
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Gandotra, S (författare)
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Gibbs, KW (författare)
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Henderson, PT (författare)
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Ittner, CAG (författare)
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Jauregui, A (författare)
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Khan, KT (författare)
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Koff, JL (författare)
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Lang, J (författare)
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LaRose, M (författare)
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Levitt, J (författare)
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Lu, RX (författare)
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McKeehan, JD (författare)
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Meyer, NJ (författare)
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Russell, DW (författare)
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Thomas, KW (författare)
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- Eklund, M (författare)
- Karolinska Institutet
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Esserman, LJ (författare)
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Liu, KD (författare)
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(creator_code:org_t)
- 2022-06-06
- 2022
- Engelska.
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 12:6, s. e060664-
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http://kipublication...
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https://doi.org/10.1...
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Abstract
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- 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 analysisThe 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 disseminationISPY 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 numberNCT04488081.
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- art (ämneskategori)
Hitta via bibliotek
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BMJ open
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Till lärosätets databas
- Av författaren/redakt...
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Files, DC
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Matthay, MA
-
Calfee, CS
-
Aggarwal, NR
-
Asare, AL
-
Beitler, JR
-
visa fler...
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Berger, PA
-
Burnham, EL
-
Cimino, G
-
Coleman, MH
-
Crippa, A
-
Discacciati, A
-
Gandotra, S
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Gibbs, KW
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Henderson, PT
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Ittner, CAG
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Jauregui, A
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Khan, KT
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Koff, JL
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Lang, J
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LaRose, M
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Levitt, J
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Lu, RX
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McKeehan, JD
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Meyer, NJ
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Russell, DW
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Thomas, KW
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Eklund, M
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Esserman, LJ
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Liu, KD
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visa färre...
- Artiklar i publikationen
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BMJ open
- Av lärosätet
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Karolinska Institutet