EUCTR2015-002340-14-FR进行中(未招募)1 期
Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia Coronavirus COVID-19 (REMAP-CAP-COVID-19) - REMAP-CAP
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
- •1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with
- •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
- •3. Proven or suspected COVID-19 infection
- •Precisions for the French part :
- •1.Patients under guardianship or curatorship
- •2.Informed written consent of the patient or a legally authorized close relative, or emergency procedure.
- •In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.
- •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
- •1.Non COVID-19 pneumonia
- •Precisions for the French part :
- •1.Patients under guardianship or curatorship
- •2.Informed written consent of the patient or a legally authorized close relative, or emergency procedure.
- •In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.
研究者
相似试验
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaCOVID-19MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsEUCTR2015-002340-14-NLniversity Medical Center Utrecht20,000
招募中
4 期
Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP)influenzapneumoniaNL-OMON53023niversitair Medisch Centrum Utrecht1,000
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862EUCTR2015-002340-14-FIniversity Medical Center Utrecht4,000
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaCOVID-19InfluenzaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsEUCTR2015-002340-14-DEniversity Medical Center Utrecht8,000
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862EUCTR2015-002340-14-ESniversity Medical Center Utrecht4,000
