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Evaluating Clinical Parameters of COVID-19 in Pregnancy (COpregVID)

2020年10月9日更新者：Chelsea and Westminster NHS Foundation Trust

Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)

Coronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.

研究概览

地位

未知

条件

详细说明

This study will be a retrospective case review using existing clinical data from participating centres. To date there have already been 18,000 confirmed cases in Greater London. Our study design will aim to include patients who were diagnosed with COVID-19 at the start of the pandemic as well as new and current cases.

The study design requires data to be extracted from National Health Service (NHS) electronic and paper notes, which will contain patient identifiable information. For confidentiality, all patient identifiable data will only be collected by members of the direct care team. This data will be encrypted and stored in a local NHS trust computer at participating sites. In order to maintain confidentiality, all data will then be anonymised before being inputted on a data collection tool and spreadsheet. Therefore, research teams will only be provided with a de-identified dataset. This data will be transferred across to the study co-ordination centre, following NHS information governance rules for data to be compiled and analysed. At the co-ordination centre, this data will be stored in an Imperial College London computer, and will only be accessible to the research team.

研究类型

观察性的

注册 (预期的)

116

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：Research Delivery Operations Manager
电话号码：020 3315 6825
邮箱：research.development@chewest.nhs.uk

研究联系人备份

姓名：Natasha Singh, MRCOG, MD
邮箱：Natasha.Singh@chelwest.nhs.uk

学习地点

英国
- - London、英国、SW10 9NH
    - 招聘中
    - Chelsea and Westminster Hospital
    - 接触：
      
      Natasha Singh
    - 首席研究员：
      
      Nishel Shah, MRCOG, PhD
  - London、英国、SW10 9NH
    - 招聘中
    - Chelsea and Westminster Hospital NHS Foundation Trust
    - 接触：
      
      Natasha Singh, MRCOG; MD
      
      邮箱：Natasha.Singh@chelwest.nhs.uk
    - 首席研究员：
      
      Nishel Shah

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年至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Due to the novel nature of this project, patients will not be stratified for specific demographic differences such as age, ethnicity or BMI. As there is very little data on SARS or COVID-19 infection in pregnant and postnatal women within 6 weeks of birth, power calculations used data from non-pregnant cases. In our institution so far, we have had 17 pregnant or postnatal women with COVID-19, and approximately 5 non-pregnant women of childbearing age out of a total of 273 cases (as of 1nd May 2020). Therefore, for some of non-pregnant data collection, we will be using data obtained from both male and female participants with a wider age range than our pregnant and postnatal group. Once all the data has been collected, we may stratify them based on age, gender, BMI, and ethnicity.

描述

Inclusion Criteria:

COVID-19 infection
18-50 years for Groups A and B and 18-60 years for Groups C and D
Female for groups A and B. Both male and female for groups C and D.

Exclusion Criteria:

Participants who have previously been part of a SARS-CoV-2 vaccine trial.
Current hospital admission due to another respiratory disease, such as influenza.
Obvious clinical deterioration due to another medical problem such as cardiovascular disease, diabetes or malignancy.
Evidence of HIV infection and/or participants on anti-retroviral drug therapy.
Participants on chemotherapy, biologics, immune-modulators or immunosuppressive drugs (not including intramuscular steroids for fetal lung maturity).

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

队列和干预

团体/队列团体/队列观察性研究中评估生物医学或健康结果的一组或一组参与者。
Mild/moderate COVID-19 affected pregnant and postnatal women Pregnant and postnatal women who contracted COVID-19 and recovered without the need for ventilation will be classified as mild to moderate. Participants will be aged between 18-50 years old.
Severe/Critical COVID-19 affected pregnant and postnatal women Pregnant and postnatal women who are admitted to hospital after contracting COVID-19 and received ventilatory support before recovering will be classified as severe to critical. Participants will be aged between 18-50 years old. These participants will be identified from Intensive Treatment Unit (ITU), and standard COVID-19 wards.
Mild/moderate COVID-19 affected non-pregnant participants Both male and non-pregnant female participants who contracted COVID-19 and recovered without the need for ventilation will be classified as mild to moderate. Participants will be aged between 18-60 years old.
Severe/Critical COVID-19 affected non-pregnant participants Both male and non-pregnant female participants who are admitted to hospital after contracting COVID-19 and received ventilatory support before recovering will be classified as severe to critical. Participants will be aged between 18-60 years old. These participants will be identified from Intensive Treatment Unit (ITU), and standard COVID-19 wards.

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
Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women. 大体时间：From the start of the study up until one month prior to study end.	Data collection and analysis on the proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive patients during acute infection and recovery.	From the start of the study up until one month prior to study end.
Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women. 大体时间：From the start of the study up until one month prior to study end.	Data collection and analysis on the concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive patients during acute infection and recovery.	From the start of the study up until one month prior to study end.

次要结果测量

结果测量	措施说明	大体时间
Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women. 大体时间：From the start of the study up until one month prior to study end.	Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.	From the start of the study up until one month prior to study end.

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

Chelsea and Westminster NHS Foundation Trust

调查人员

首席研究员：Nishel Shah, MRCOG, PhD、Chelsea and Westminster Hospital NHS Foundation Trust

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

有用的网址

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10月9日

初级完成 (预期的)

2021年11月1日

研究完成 (预期的)

2021年12月2日

研究注册日期

首次提交

2020年7月13日

首先提交符合 QC 标准的

2020年7月13日

首次发布 (实际的)

2020年7月14日

研究记录更新

最后更新发布 (实际的)

2020年10月12日

上次提交的符合 QC 标准的更新