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Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (ProPAC-COVID)

2021年6月28日 更新者：Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Proactive Protection With Azithromycin and Hydroxychloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

研究概览

地位

终止

条件

干预/治疗

详细说明

In the ongoing coronavirus pandemic, COVID-19, that arose in Wuhan China, there is still sparse data in the course, risk of various complications, and in particular how patients who are hospitalized are best treated to ensure high survival and short hospitalization. Despite the rapid spread of the disease globally, there is no solid data yet to recommend any specific treatments, which is why symptomatic, organ supportive therapy including respiratory therapy in acute pulmonary failure is recommended. There has been reported a high incidence of bacterial super-infections in patients with COVID-19. Patients with COVID-19 also have a higher risk of dying because of septic shock. Thus, there is an urgent need for treatment that can improve the patient's chance of the shortest hospitalization possible, and treatment that can lower the risk of secondary infection and death.

This is a randomized, placebo-controlled, double-blinded multi-center trial evaluating the effect of azithromycin and hydroxychloroquine treatment in patients with COVID-19 during hospitalization. The aim of the study is to investigate whether the treatment can shorten hospitalization, reduce the risk of non-invasive ventilation, admittance to Intensive Care Units and death.

研究类型

介入性

注册 (实际的)

117

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。

学习地点

  • 丹麦
      • Aalborg、丹麦
        • Aalborg Sygehus
      • Copenhagen、丹麦
        • Bispebjerg Hospital
      • Copenhagen、丹麦
        • Hvidovre Hospital
      • Copenhagen、丹麦
        • Herlev-Gentofte Hospital
      • Hillerød、丹麦
        • Nordsjællands Hospital
      • Odense、丹麦
        • Odense Universitetshospital
      • Roskilde、丹麦
        • Roskilde Sygehus
      • Slagelse、丹麦
        • Slagelse Sygehus

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

  • 孩子
  • 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:

  • Patient admitted to a Danish emergency department, lung medical department or medical department
  • Age >18 years
  • Hospitalized <48 hours
  • Positive COVID-19 test/diagnosis during the hospitalization
  • Signs informed consent

Exclusion Criteria:

  • If the patient uses > 5 LO2/min at time of recruitment
  • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinolinderivates
  • Pregnancy
  • Breastfeeding
  • Neurogenic hearing loss
  • Psoriasis
  • Retinopathy
  • Maculopathy
  • Changes in vision field
  • Severe liver disease other than amoebiases
  • Severe gastrointestinal, neurological or haematological disorders
  • eGFR < 45 ml/min/1.73m2
  • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval
  • Myasthenia Gravis
  • Uses Digoxin
  • Glucose-6-phosphate dehydrogenase deficiency
  • Porphyria
  • Hypoglycemia at any time since hospitalization
  • Severe mental illness which significantly impedes cooperation
  • Severe linguistic problems that significantly impedes cooperation
  • Treatment with sickle alkaloids

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：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Control

This arm will receive standard care and placebo in 15 days.

Azithromycin placebo:

Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1

Hydroxychloroquine placebo:

Day 1-15: 200 mg x 2
药品：Placebo oral tablet
Placebo Azithromycin
药品：Placebo oral tablet
Placebo Hydroxychloroquine
有源比较器：Intervention

This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.

Azithromycin:

Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1

Hydroxychloroquine:

Day 1-15: 200 mg x 2
药品：羟氯喹
羟氯喹
药品：阿奇霉素
阿奇霉素

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of Days Alive and Discharged From Hospital Within 14 Days
大体时间：14 days
14 days

次要结果测量

结果测量
措施说明
大体时间
死亡
大体时间：30天
30天
死亡
大体时间：90天
90天
死亡
大体时间：365天
365天
Categorization of Hospitalization Status
大体时间：14 days

The patient will be categorized into one of the following 8 categories depending on status of their hospitalization:

  1. Dead (yes/no)
  2. Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no)
  3. Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no)
  4. Hospitalized and given oxygen supplements different from (2) and (3) (yes/no)
  5. Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no)
  6. Hospitalized for observation (yes/no)
  7. Discharged from hospital with restriction of activity level (yes/no)
  8. Discharged from hospital without any restrictions of activity level (yes/no)

Only one category can be "yes".
14 days
Length of Stay in ICU
大体时间：14 days
Length of stay in intensive care unit.
14 days
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization
大体时间：14 days
14 days
Length of Hospitalization
大体时间：14 days
14 days
Days Alive and Discharged From Hospital
大体时间：30 days
30 days
Number of Readmissions (All Causes)
大体时间：30 days
30 days
Number of Days Using Non-invasive Ventilation (NIV)
大体时间：14 days
Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.
14 days
Change in Patient's Oxygen Partial Pressure
大体时间：4 days
PaO2 measured in arterial puncture at baseline and 4 days.
4 days
Change in Patient's Carbondioxide Partial Pressure
大体时间：4 days
PaCO2 measured in arterial puncture at baseline and 4 days.
4 days
Change of pH in Blood
大体时间：4 days
pH measured in arterial puncture at baseline and 4 days.
4 days
Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")
大体时间：14 days
Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.
14 days

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。

赞助

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2020年4月6日

初级完成 (实际的)

2021年2月2日

研究完成 (实际的)

2021年2月2日

研究注册日期

首次提交

2020年3月23日

首先提交符合 QC 标准的

2020年3月24日

首次发布 (实际的)

2020年3月26日

研究记录更新

最后更新发布 (实际的)

2021年6月29日

上次提交的符合 QC 标准的更新

2021年6月28日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • KronLungesyg_COVID_19_protokol

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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