EUCTR2015-002340-14-FI进行中（未招募）1 期
Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) - REMAP-CAP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •General REMAP-CAP Inclusion Criteria (including adaptations for the pandemic domain)
- •1. Adult patient admitted to an ICU for acute severe CAP
- •a. symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND
- •b. Radiological evidence of new onset infiltrate of infective origin (in patients with pre-existing radiological changes, evidence of new infiltrate)
- •2. Up to 48 hours after ICU admission, receiving organ support with one or more of:
- •a. Non-invasive or invasive ventilatory support;
- •b. Receiving infusion of vasopressor or inotropes or both
- •Additional inclusions for the COVID-19 immunomodulation domain:
- •COVID-19 infection is suspected by the treating clinician or has been confirmed by microbiological testing
- •Microbiological testing for SARS-CoV-2 infection of upper or lower respiratory tract secretions or both has occurred or is intended to occur
- •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 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •General REMAP-CAP Exclusion Criteria adapted for the pandemic domain:
- •1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.
- •2. Previous participation in this REMAP within the last 90 days
- •COVID-19 Immune Modulation domain:
- •Patients will be excluded from this domain if they have any of the following:
- •More than 24 hours has elapsed since ICU admission
- •Patient has already received any dose of any form of interferon or anakinra, or is on long-term therapy with any of these agents prior to this hospital admission
- •Known condition or treatment resulting in ongoing immune suppression including neutropenia prior to this hospitalization
- •Patient has been randomized in a trial evaluating an immune modulation agent for proven or suspected COVID-19 infection, where the protocol of that trial requires ongoing administration of study drug
- •The treating clinician believes that participation in the domain would not be in the best interests of the patient
- •Patients may also be excluded from receiving one or more interventions within the domain for patient-specific reasons. In such cases, patients will be randomly allocated a remaining intervention from among those available at that site.
- •Patients who are eligible for only a single intervention at a site (i.e. all other interventions are contraindicated) are not eligible for this domain. Patients in whom all interventions are contraindicated will be treated according to the current standard of care at the clinician’s discretion.
- •Known hypersensitivity to an agent specified as an intervention in this domain will exclude a patient from receiving that agent
- •Receiving an agent that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent
- •Intention to prescribe systemic corticosteroids for any reason, other than participation in the Corticosteroid Domain of this platform, will result in exclusion from receiving IFN-ß1a
- •Known hypersensitivity to proteins produced by E. coli will result in exclusion from receiving anakinra
- •Known or suspected pregnancy will result in exclusion from the anakinra and IFN-ß1a interventions. It is normal clinical practice that women admitted who are in an age group in which pregnancy is possible will have a pregnancy test conducted. The results of such tests will be used to determine interpretation of this exclusion criteria.
研究者
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