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

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ClinicalTrials.gov Identifier: NCT04470583
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

Brief Summary:
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.

Condition or disease
COVID-19 2019 Novel Coronavirus Infection COVID-19 Infection

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women. [ Time Frame: 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.

  2. Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470583


Contacts
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Contact: Research Delivery Operations Manager 020 3315 6825 research.development@chewest.nhs.uk
Contact: Natasha Singh, MRCOG, MD Natasha.Singh@chelwest.nhs.uk

Locations
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United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW10 9NH
Contact: Research Delivery Operations Manager    020 3315 6825    research.development@chelwest.nhs.uk   
Contact: Natasha Singh, MRCOG; MD       Natasha.Singh@chelwest.nhs.uk   
Principal Investigator: Nishel Shah         
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Research Delivery Operations Manager    020 3315 6825    research.development@chelwest.nhs.uk   
Contact: Natasha Singh         
Principal Investigator: Nishel Shah, MRCOG, PhD         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
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Principal Investigator: Nishel Shah, MRCOG, PhD Chelsea and Westminster Hospital NHS Foundation Trust
Additional Information:
Publications:
ICNARC report on COVID-19 in critical care London, UK: Intensive Care National Audit & Research Centre (ICNARC); 2020 04 April 2020.
Bouch, D. C., & Thompson, J. P. (2008). Severity scoring systems in the critically ill. Continuing Education in Anaesthesia Critical Care & Pain, 8(5), 181-185. https://doi.org/10.1093/bjaceaccp/mkn033
Greer O, Shah NM, Johnson MR. Maternal sepsis update: current management and controversies. The Obstetrician & Gynaecologist. 2020;22(1):45-55.
Zheng Y, Huang Z, Ying G, Zhang X, Ye W, Hu Z, et al. Study of the lymphocyte change between COVID-19 and non-COVID-19 pneumonia cases suggesting other factors besides uncontrolled inflammation contributed to multi-organ injury. medRxiv. 2020:2020.02.19.20024885.

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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04470583    
Other Study ID Numbers: C&W20/034
283995 ( Other Identifier: Integrated Research Application System (IRAS) )
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Research team wishes to enable any meta-analyses of COVID-19 trials making appropriate requests. No plan to share IPD has been made at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chelsea and Westminster NHS Foundation Trust:
COVID-19
Pregnancy
Retrospective case review
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases