Ruxolitinib therapy to Avoid Ventilation and improve outcome for deteriorating COVID-19 patiENts - RAVEN - RAVE

Guy’s and St Thomas' NHS Foundation Trust0 个研究点目标入组 59 人开始时间: 2020年4月30日最近更新: 2020年6月29日

试验速览

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•1.Patients admitted to Guy’s and St. Thomas’ NHS Foundation Trust with swab proven COVID-19
•2.Deemed eligible at the time of admission for escalation to mechanical ventilation if required.
•3.Worsening clinical and laboratory features suggestive of COVID-19 disease progression:
•‘Yellow or Amber Category’ as judged on the current GSTT action card 21: Adult Escalation Plan for Patients with Confirmed or Suspected Covid-19 despite optimisation (example in Figure 2)
•have respiratory rate >/= 20 at any time in 24 hours prior to recruitment.
•At least two of either:
•Serum ferritin levels >1000ng/mL
•D-dimer raised >1 µg/mL
•4.Greater than 18 years of age and ability to grant full consent for repurposed use of ruxolitinib
•5.No excluded concomitant medication
•6.Written informed consent to participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 59
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 59

•1.Those patients below age 18 years of age
•2.Not proven to have COVID-19 disease
•3.Inability to grant informed consent
•4.Not meeting the inclusion criteria for both clinical and biochemical features as above.
•5.Pregnant or lactating and breast-feeding women
•6.Unwilling to use contraception as detailed in section 5.3
•7.Neutrophil counts <1.0X109/L or platelets <100x109/L
•8.Inadequate liver function as defined by ALT/AST >5 x ULN
•9.Inadequate renal function as defined by GFR < 30 mls/min
•10.Patients already taking JAK inhibitor therapy
•11.Patients currently enrolled in another study of an investigational medicinal product. Of note, treatment with the antiviral agent remdesivir is permitted.
•12.Any known contraindication or hypersensitivity to JAK inhibitor therapy (or any of the IMP excipients) such as untreated active hepatitis B or HIV

发起方

Guy’s and St Thomas' NHS Foundation Trust