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临床试验/NL-OMON54916
NL-OMON54916已完成2 期

Alkaline phosphatase for reducing systemic inflammatory response syndrome (SIRS) in patients with Sars-CoV-2 infection and acute respiratory insufficiency (COVID 19) - COVID-RESCAP

Rode Kruis Ziekenhuis0 个研究点目标入组 106 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
106

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Sars-CoV-2 infection based on: highly clinical suspicion on admission and/or
  • positive PCR test on naso-pharynx swab or sputum and/or a CT imaging of the
  • chest compatible with COVID-19 + type 1 or type 2 respiratory failure needing
  • supplemental oxygen that indicates airway support or ICU admittance and meeting
  • any of the following criteria: .
  • - SpO2 <90% or PaO2/FiO2 < 200 mmHg
  • - Clinical evidence of respiratory distress (RR > 25 breaths/minute)

排除标准

  • - Inclusion in another interventional clinical trial
  • - Age < 18
  • - Age > 80
  • - Patients who are pregnant or lactating
  • - Patients expected to have fatal disease within 24 hours
  • - Patients who are already on dialysis (Renal Replacement Therapy, RRT) or a
  • decision has been made to initiate RRT within 24 hours after planned start of
  • study drug administration
  • - Patients who have advanced chronic liver disease confirmed by a Child-Pugh C
  • - Patients who are having a known history of immune system that has been
  • impaired by disease, such as patients with HIV and with a CD4 count of less
  • than 200 cells/mm, neutropenic patients (<0.5 x 109/l) Patients who are
  • receiving chronic high doses (equivalent to prednisone/prednisolone 0.5
  • mg/kg/day) steroids therapy immediately prior to recruitment exceeding 2 weeks
  • of treatment. This means dexamethasone 6 mg once daily serving as treatment for
  • severe COVID-19 is not an exclusion criterion.
  • - Patients with active haematological malignancy

研究者

发起方
Rode Kruis Ziekenhuis

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