Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO) (IPCO)
2021年1月19日 更新者：University of Erlangen-Nürnberg Medical School
Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.
研究概览
详细说明
The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.
The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.
As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.
The study design will be prospective, open-label, randomized, controlled and parallel-grouped.
研究类型
介入性
注册 (预期的)
58
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mario Schiffer, MD
- 电话号码：39002 +49913185
- 邮箱：mario.schiffer@uk-erlangen.de
研究联系人备份
- 姓名：Holger Hackstein, MD
- 电话号码：42110 +49913185
- 邮箱：Holger.Hackstein@uk-erlangen.de
学习地点
-
-
-
Erlangen、德国
- 招聘中
- University Hospital Erlangen
-
接触：
- Carsten Willam, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female subject aged ≥18 years.
- Estimated BMI ≥19kg/m² to ≤40kg/m².
- Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
- ARDS with Horovitz index <300mmHg.
- Necessity of invasive mechanical ventilation.
- Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
- Subject's assent if obtainable
Exclusion Criteria:
- Previous exposure to COVID-19 convalescent plasma.
- Adverse reaction to plasma proteins in medical history.
- Interval >72h since endotracheal intubation.
- Current or imminent necessity of ECMO treatment.
- Pre-existing COPD GOLD stage 4.
- Chronic congestive heart failure NYHA ≥3.
- Pre-existing left ventricular ejection fraction <30%.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：COVID-19 convalescent plasma
A total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 and standard treatment.
|
Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.
|
|
无干预：Standard treatment
Standard treatment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in SOFA score from Baseline Visit
大体时间：[Day 1, Visit 2] to Day 8 [Visit 9]
|
Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data.
SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets.
All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score.
The lower the SOFA score, the better is the prognosis (Maximum value 24)
|
[Day 1, Visit 2] to Day 8 [Visit 9]
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean number of days without invasive mechanical ventilation during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject. Time from Baseline Visit [Day 1, Visit 2] to extubation. |
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of mortality during defined time-frame
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Number of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Proportion of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean number of days without supplemental oxygen during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean relative change of PEEP from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean relative change of FiO2 from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean relative change of driving pressure from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19
大体时间：Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Time from Baseline Visit [Day 1, Visit 2] to stop of invasive mechanical ventilation.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Carsten Willam, MD、University Hospital Erlangen
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月18日
初级完成 (预期的)
2021年9月1日
研究完成 (预期的)
2021年9月1日
研究注册日期
首次提交
2020年12月30日
首先提交符合 QC 标准的
2021年1月14日
首次发布 (实际的)
2021年1月15日
研究记录更新
最后更新发布 (实际的)
2021年1月20日
上次提交的符合 QC 标准的更新
2021年1月19日
最后验证
2021年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
严重的 COVID-19的临床试验
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention Srl完全的
-
Yang I. Pachankis主动，不招人COVID-19 呼吸道感染 | COVID-19 压力综合症 | COVID-19 疫苗不良反应 | COVID-19 相关血栓栓塞 | COVID-19 重症监护后综合症 | COVID-19 相关中风中国
-
Erasmus Medical CenterDa Vinci Clinic; HGC Rijswijk尚未招聘COVID-19 后综合症 | 长COVID | 长Covid19 | COVID-19 后状况 | 后 COVID 综合症 | COVID-19 后状况，未指定 | 新冠疫情后的状况荷兰
-
Endourage, LLC招聘中长COVID | 长Covid19 | 后急性 COVID-19 | 长途 COVID | 长途 COVID-19 | 急性 COVID-19 后综合症美国
-
National Institutes of Health Clinical Center (CC)完全的COVID-19 对全身炎症的急性和长期影响 | COVID-19 对肺功能的急性和长期影响 | COVID-19 对心脏功能的急性和长期影响 | COVID-19 对肾功能的急性和长期影响 | COVID-19 对脑功能的急性和长期影响美国
-
Jonathann Kuo, MD主动，不招人SARS-CoV2 感染 | COVID-19 后综合症 | 自主神经障碍 | 急性 COVID-19 后综合症 | 长COVID | 长Covid19 | COVID-19 复发 | 后急性 COVID-19 | 急性 COVID-19 后感染 | COVID-19 的急性后遗症 | 自主神经样障碍 | 自主神经功能障碍直立性低血压综合征 | COVID-19 后状况 | 后 COVID 综合症 | COVID-19 后状况，未指定美国
-
Indonesia University招聘中
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung Norderney完全的
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin No.2 Hospital; Nuclear 215 Hospital of Shaanxi Province 和其他合作者招聘中
-
Medisch Spectrum TwenteZiekenhuisgroep Twente; University of Twente主动，不招人
COVID-19 convalescent plasma的临床试验
-
University of PennsylvaniaPublic Health Management Corporation完全的
-
Raphael SerreauAssistance Publique - Hôpitaux de Paris; University Hospital, Paris; François Rabelais University完全的
-
University of PennsylvaniaPublic Health Management Corporation完全的
-
Kanuni Sultan Suleyman Training and Research HospitalAyşegül Bestel; İbrahim Polat; Merve Aldıkaçtıoğlu Talmaç完全的
-
Hospital Moinhos de VentoPfizer; Universidade Federal do Paraná; Inova Medical完全的