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Tofacitinib versus standard of care treatment in patients with COVID-19: a multicenter non-randomized controlled study
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  • Sergey Moiseev,
  • Nikolay Bulanov,
  • Anastasiia Zykova,
  • Michail Brovko,
  • Pavel Novikov,
  • Larisa Akulkina,
  • Natalia Chichkova,
  • Natalia Trushenko,
  • Maria Lukina,
  • Yuriy Sorokin,
  • Ekaterina Tao,
  • Ekaterina Filatova,
  • Aram Kitbalyan,
  • Pavel Potapov,
  • Lubov Ermolova,
  • Olga Suvorova,
  • Augusto Vaglio,
  • Andreas Kronbichler,
  • Sergey Avdeev,
  • Victor Fomin
Sergey Moiseev
Sechenov First Moscow State Medical University
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Nikolay Bulanov
Sechenov First Moscow State Medical University
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Anastasiia Zykova
Lomonosov Moscow State University
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Michail Brovko
Sechenov First Moscow State Medical University
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Pavel Novikov
Sechenov First Moscow State Medical University
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Larisa Akulkina
Sechenov First Moscow State Medical University
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Natalia Chichkova
Sechenov First Moscow State Medical University
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Natalia Trushenko
Sechenov First Moscow State Medical University
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Maria Lukina
Sechenov First Moscow State Medical University
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Yuriy Sorokin
Sechenov First Moscow State Medical University
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Ekaterina Tao
Sechenov First Moscow State Medical University
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Ekaterina Filatova
Sechenov First Moscow State Medical University
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Aram Kitbalyan
Sechenov First Moscow State Medical University
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Pavel Potapov
Sechenov First Moscow State Medical University
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Lubov Ermolova
Sechenov First Moscow State Medical University
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Olga Suvorova
Sechenov First Moscow State Medical University
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Augusto Vaglio
University of Firenze
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Andreas Kronbichler
University of Cambridge
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Sergey Avdeev
Sechenov First Moscow State Medical University
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Victor Fomin
Sechenov First Moscow State Medical University
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Abstract

This non-randomized controlled study aimed to assess the efficacy of tofacitinib in reducing the risk of invasive mechanical ventilation or death in patients with COVID-19. Patients with COVID-19 associated with reduced oxygen saturation, increased C-reactive protein (≥50 mg/L), and/or persisting fever were recruited. Tofacitinib was administered in addition to standard of care therapy. Study outcomes were evaluated separately in the groups of patients with oxygen saturation at rest ≤93% and >93%. Hazard ratios (HR) with 95% confidence intervals (CI) were calculated using Cox regression analysis adjusted for inverse propensity score weighting. Overall, 384 patients with COVID-19 (212 males; median age 60 years) were included in our study and were treated with tofactinib (n=131) or standard of care alone (n=253). The percentages of patients who started mechanical ventilation or died during hospitalization in the tofacitinib and control groups were 12.5% (9/72) vs. 14.1% (26/185) among patients who required respiratory support (HR 0.92, 95% CI 0.33-2.56), and 1.7% (1/59) vs. 4.4% (3/68) in those with normal oxygen saturation (HR 0.83; 95 CI 0.07-9.44). Tofacitinib did not reduce the risk of invasive mechanical ventilation or death in patients with COVID-19, although the analysis of these outcomes favored tofacitinib.

Peer review status:UNDER REVIEW

04 Jul 2021Submitted to Clinical & Experimental Immunology
05 Jul 2021Assigned to Editor
05 Jul 2021Submission Checks Completed
06 Jul 2021Reviewer(s) Assigned