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10.1016/j.conctc.2021.100716

http://scihub22266oqcxt.onion/10.1016/j.conctc.2021.100716
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33495742!7817439!33495742
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suck abstract from ncbi


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pmid33495742      Contemp+Clin+Trials+Commun 2021 ; 21 (ä): 100716
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  • Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: The TACROVID trial protocol #MMPMID33495742
  • Solanich X; Antoli A; Padulles N; Fanlo-Maresma M; Iriarte A; Mitjavila F; Capdevila O; Molina M; Sabater J; Bas J; Mensa-Vilaro A; Niubo J; Calvo N; Bolivar S; Rigo-Bonnin R; Arregui L; Tebe C; Hereu P; Videla S; Corbella X
  • Contemp Clin Trials Commun 2021[Mar]; 21 (ä): 100716 PMID33495742show ga
  • INTRODUCTION: Some COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients. METHODS: and analysis: TACROVID is a randomized, open-label, single-center, phase II trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature 400 and/or SatO2/FiO2 > 300, and respiratory rate
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