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临床试验/ISRCTN67000769
ISRCTN67000769进行中（未招募）未知

Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP)

niversity Medical Center Utrecht0 个研究点目标入组 4,400 人开始时间: 2020年7月20日最近更新:
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试验速览

阶段
未知
状态
进行中（未招募）
入组人数
4,400
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32267771/ protocol (added 16/07/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32876697/ results for hydrocortisone (added 03/09/2020) 2021 Preprint results in https://doi.org/10.1101/2021.01.07.21249390 results for tocilizumab and sarilumab in preprint (added 08/01/2021) 2021 Results article in https://doi.org/10.1056/NEJMoa2100433 results for tocilizumab and sarilumab (added 18/03/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •Current participant inclusion criteria as of 19/04/2021:
  • •Non-pandemic participants:
  • •1. Adult patient admitted to an ICU for severe CAP within 48 h of hospital admission with both of the following:
  • •1.1. Symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain)
  • •1.2. Radiological evidence of new-onset consolidation (in-patients with pre-existing radiological changes, evidence of new infiltrate)
  • •2. Requiring organ support with one or more of:
  • •2.1. Non-invasive or invasive ventilatory support
  • •2.2. Receiving infusion of vasopressor or inotropes or both
  • •Pandemic participants:
  • •1. Adult patient with confirmed or suspected pandemic infection
  • •Domain-specific criteria:
  • •Antiviral domain:
  • •1. COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
  • •2. Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
  • •Immune modulation domain:
  • •1. COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
  • •2. Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
  • •Immunoglobulin domain:
  • •1. COVID-19 infection is confirmed by microbiological testing
  • •Therapeutic anticoagulation domain:
  • •1. COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
  • •2. Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
  • •Updated anticoagulation domain:
  • •1. COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
  • •2. Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
  • •Antiplatelet domain:
  • •1.COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
  • •2. Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
  • •Simvastatin Domain:
  • •1. COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
  • •2. Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
  • •Vitamin C domain:
  • •1. COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
  • •2. Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
  • •ACE2 RAS domain:
  • •1. COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological t

排除标准

  • •Current participant exclusion criteria as of 19/04/2021:
  • •Non-pandemic participants:
  • •1. Healthcare-associated pneumonia:
  • •1.1 Prior to this illness, has been an in-patient in any healthcare facility within the last 30 days
  • •1.2. Resident of a nursing home or long term care facility
  • •2. Death is deemed imminent or inevitable during this hospital admission and >1 of the patient, substitute decision-maker, or attending physician are not committed to full active treatment
  • •3. Previous participation in this REMAP within the last 90 days
  • •Pandemic participants:
  • •1. Death is deemed imminent or inevitable during the next 24 h and >1 of the patient, substitute decision-maker, or attending physician are not committed to full active treatment
  • •2. Admission to hospital over 14 days ago with acute COVID illness
  • •3. Expected to be discharged from hospital today or tomorrow
  • •4. Previous participation in this REMAP within the last 90 days
  • •Domain-specific criteria:
  • •Antibiotic domain:
  • •1. Received >48 h of intravenous antibiotic treatment for this index illness
  • •2. >24 h have elapsed since becoming eligible for this domain
  • •3. Known hypersensitivity to all of the study drugs in the site randomization schedule
  • •4. A specific antibiotic choice is indicated
  • •5. The treating clinician believes that participation in the domain would not be in the best interests of the patient
  • •6. If randomised to a beta-lactam plus macrolide intervention within the antibiotic domain and the treating clinician believes that participation in the domain would not be in the best interests of the patient
  • •Corticosteroid domain:
  • •1. An indication to prescribe systemic corticosteroids for a reason other than community-acquired pneumonia (CAP) (or severe sepsis) such as chronic corticosteroid use before admission, acute severe asthma, or suspected or proven pneumocystis jiroveci pneumonia
  • •2. Have received an immunomodulatory dose of systemic corticosteroid therapy for >24 h prior to the time of enrolment. An immunomodulatory dose is defined as >20 mg of hydrocortisone, >5 mg prednisone, >4 mg methylprednisolone or >0.8 mg dexamethasone per 24 h
  • •3. The treating clinician believes that participation in the domain would not be in the best interests of the patient
  • •Antiviral domain:
  • •1. >24 h have elapsed since ICU admission
  • •2. Has already received >36 h of treatment with any non-trial prescribed systemic antiviral medication intended to be active against COVID-19 during this hospital admission
  • •3. Has been randomized in a trial evaluating an antiviral intended to be active against COVID-19, where the protocol of that trial requires ongoing administration of study drug
  • •4. In areas where MERS-CoV infection is endemic, laboratory-confirmed MERS-CoV infection
  • •5. The treating clinician believes that participation in the domain would not be in the best interests of the patient
  • •6. Known hypersensitivity to an agent specified as an intervention in this domain
  • •7. Receiving an agent that is specified as an int

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