JPRN-jRCT2031200443已完成3 期
REMAP-CAP:Randomized,Embedded,Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia Immune Modulation-2 Domain - REMAP-CAP:IM-2
Fujitani Shigeki0 个研究点目标入组 27 人开始时间: 2021年3月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
nknown because analysis has not been performed due to discontinuation
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •SARS-CoV-2 infection is confirmed by local microbiological testing.
- •(1) Adult patients(>=20 years old) who have acute illness due to confirmed COVID infection in the moderate State, and admitted to hospital
- •(2) Given written informed consent to participate in the study from the patient (or legal representative)
排除标准
- •1) Death is deemed to be imminent and inevitable during the next 24 hours AND the patient and/or a treating team is not committed to full active treatment.
- •2) Expected to be discharged from hospital today or tomorrow
- •3) >=14 days while admitted to hospital with symptoms of COVID-19
- •4) Previous participation in this REMAP within the last 90 days
- •5) Has already received any dose of one or more of any form of immune modulators during this hospitalization
- •6) Is on long-term therapy or has been randomized in a trial evaluating an immune modulation agent for confirmed COVID-19 infection
- •7) The treating clinician believes that participation in the domain would not be in the best interests of the patient
- •8) Known active current or history of mycobacterial disease
- •9) Receiving a mean dose of >0.5 mg/kg prednisone or equivalent dose of another agent in the 7 days prior to eligibility assessment, except if used as a treatment for septic shock or severe COVID-19 disease
- •10) Known pregnancy or pregnancy status unknown in female of child-bearing age
- •11) Known immunosuppressive therapy
- •12) Ongoing breastfeeding or plan to breastfeed
- •13) Known hypersensitivity to active ingredient or any of the excipients
- •14) Chemotherapy or other cancer treatment for >= 3 months
- •15) Neutrophil count < 1000/mm^3 unless believed due to COVID-19
- •16) HIV-positive patients with CD4 count <= 50/mm^3 within 4 weeks of enrollment, or end-stage processes
- •17) EF < 35%
- •18) Known severe liver disease (Child C)
- •19) Ongoing or planned use of polymyxin B, hemofiltration, endotoxin removal devices,plasma exchange, in the absence of renal impairment
- •20) Known or estimated weight greater than 150 kg
研究者
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