<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470583</url>
  </required_header>
  <id_info>
    <org_study_id>C&amp;W20/034</org_study_id>
    <secondary_id>283995</secondary_id>
    <nct_id>NCT04470583</nct_id>
  </id_info>
  <brief_title>Evaluating Clinical Parameters of COVID-19 in Pregnancy</brief_title>
  <acronym>COpregVID</acronym>
  <official_title>Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chelsea and Westminster NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chelsea and Westminster NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronavirus infection, also known as COVID-19, has become a global pandemic with over 3&#xD;
      million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses&#xD;
      that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver&#xD;
      and nervous systems. Prior to the discovery of the current novel coronavirus strain&#xD;
      (SARS-CoV-2), there were six different strains that are known to infect humans, which&#xD;
      includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002.&#xD;
      In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of&#xD;
      the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia&#xD;
      and during SARS more pregnant women required intensive care and breathing support, and the&#xD;
      proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney&#xD;
      failure and development of abnormal blood clotting disorders, which occurs during severe&#xD;
      infection, is more common in pregnancy and the associated changes in blood vessels extend to&#xD;
      the placentas of infected pregnant women, thus potentially affecting the fetus. This makes&#xD;
      pregnant women affected by the virus at high risk of developing severe complications.&#xD;
      Fortunately, there have been a number of biomarkers identified that are associated with&#xD;
      illness severity. These include, specialised white blood cells, blood clotting cells and&#xD;
      constituents, as well as other measures of heart and kidney function. We propose that these&#xD;
      biomarkers are important correlates of clinical disease severity and prognosis in pregnant&#xD;
      and postnatal women. This knowledge has the potential to help clinicians during this pandemic&#xD;
      to better manage and care for their patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a retrospective case review using existing clinical data from&#xD;
      participating centres. To date there have already been 18,000 confirmed cases in Greater&#xD;
      London. Our study design will aim to include patients who were diagnosed with COVID-19 at the&#xD;
      start of the pandemic as well as new and current cases.&#xD;
&#xD;
      The study design requires data to be extracted from National Health Service (NHS) electronic&#xD;
      and paper notes, which will contain patient identifiable information. For confidentiality,&#xD;
      all patient identifiable data will only be collected by members of the direct care team. This&#xD;
      data will be encrypted and stored in a local NHS trust computer at participating sites. In&#xD;
      order to maintain confidentiality, all data will then be anonymised before being inputted on&#xD;
      a data collection tool and spreadsheet. Therefore, research teams will only be provided with&#xD;
      a de-identified dataset. This data will be transferred across to the study co-ordination&#xD;
      centre, following NHS information governance rules for data to be compiled and analysed. At&#xD;
      the co-ordination centre, this data will be stored in an Imperial College London computer,&#xD;
      and will only be accessible to the research team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Anticipated">December 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.</measure>
    <time_frame>From the start of the study up until one month prior to study end.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women.</measure>
    <time_frame>From the start of the study up until one month prior to study end.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.</measure>
    <time_frame>From the start of the study up until one month prior to study end.</time_frame>
    <description>Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">116</enrollment>
  <condition>COVID-19</condition>
  <condition>2019 Novel Coronavirus Infection</condition>
  <condition>COVID-19 Infection</condition>
  <arm_group>
    <arm_group_label>Mild/moderate COVID-19 affected pregnant and postnatal women</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe/Critical COVID-19 affected pregnant and postnatal women</arm_group_label>
    <description>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.&#xD;
These participants will be identified from Intensive Treatment Unit (ITU), and standard COVID-19 wards.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild/moderate COVID-19 affected non-pregnant participants</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe/Critical COVID-19 affected non-pregnant participants</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Due to the novel nature of this project, patients will not be stratified for specific&#xD;
        demographic differences such as age, ethnicity or BMI. As there is very little data on SARS&#xD;
        or COVID-19 infection in pregnant and postnatal women within 6 weeks of birth, power&#xD;
        calculations used data from non-pregnant cases. In our institution so far, we have had 17&#xD;
        pregnant or postnatal women with COVID-19, and approximately 5 non-pregnant women of&#xD;
        childbearing age out of a total of 273 cases (as of 1nd May 2020). Therefore, for some of&#xD;
        non-pregnant data collection, we will be using data obtained from both male and female&#xD;
        participants with a wider age range than our pregnant and postnatal group. Once all the&#xD;
        data has been collected, we may stratify them based on age, gender, BMI, and ethnicity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 infection&#xD;
&#xD;
          -  18-50 years for Groups A and B and 18-60 years for Groups C and D&#xD;
&#xD;
          -  Female for groups A and B. Both male and female for groups C and D.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have previously been part of a SARS-CoV-2 vaccine trial.&#xD;
&#xD;
          -  Current hospital admission due to another respiratory disease, such as influenza.&#xD;
&#xD;
          -  Obvious clinical deterioration due to another medical problem such as cardiovascular&#xD;
             disease, diabetes or malignancy.&#xD;
&#xD;
          -  Evidence of HIV infection and/or participants on anti-retroviral drug therapy.&#xD;
&#xD;
          -  Participants on chemotherapy, biologics, immune-modulators or immunosuppressive drugs&#xD;
             (not including intramuscular steroids for fetal lung maturity).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nishel Shah, MRCOG, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chelsea and Westminster NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Research Delivery Operations Manager</last_name>
    <phone>020 3315 6825</phone>
    <email>research.development@chewest.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natasha Singh, MRCOG, MD</last_name>
    <email>Natasha.Singh@chelwest.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Delivery Operations Manager</last_name>
      <phone>020 3315 6825</phone>
      <email>research.development@chelwest.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Natasha Singh, MRCOG; MD</last_name>
      <email>Natasha.Singh@chelwest.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Nishel Shah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Delivery Operations Manager</last_name>
      <phone>020 3315 6825</phone>
      <email>research.development@chelwest.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Natasha Singh</last_name>
    </contact_backup>
    <investigator>
      <last_name>Nishel Shah, MRCOG, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.who.int/emergencies/diseases/novel-coronavirus-2019</url>
    <description>The World Health Organisation's advice and guidance on the coronavirus disease (COVID-19) pandemic</description>
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  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 9, 2020</last_update_submitted>
  <last_update_submitted_qc>October 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Retrospective case review</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470583
org study id: C&W20/034
secondary id: 283995
nct id: NCT04470583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
arm group label: Mild/moderate COVID-19 affected pregnant and postnatal women
description: 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.
arm group label: Severe/Critical COVID-19 affected pregnant and postnatal women
description: 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.
arm group label: Mild/moderate COVID-19 affected non-pregnant participants
description: 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.
arm group label: Severe/Critical COVID-19 affected non-pregnant participants
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nishel Shah, MRCOG, PhD
role: Principal Investigator
affiliation: Chelsea and Westminster NHS Foundation Trust
last name: Research Delivery Operations Manager
phone: 020 3315 6825
email: research.development@chewest.nhs.uk
last name: Natasha Singh, MRCOG, MD
email: Natasha.Singh@chelwest.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
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responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No
ipd 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.