<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/NCT04405232</url>
  </required_header>
  <id_info>
    <org_study_id>20SM5934</org_study_id>
    <nct_id>NCT04405232</nct_id>
  </id_info>
  <brief_title>Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK</brief_title>
  <acronym>COVID19</acronym>
  <official_title>Coagulopathy Associated With Coronavirus disease19 (CA-COVID19) A Multi-Centre Observational Study in UK</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</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>
      A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory&#xD;
      failure [acute respiratory distress syndrome (ARDS)] and death is a global threat. On&#xD;
      11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there&#xD;
      are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop&#xD;
      dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or&#xD;
      end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged&#xD;
      Prothrombin time [PT] and raised D dimer) are reported to predict a poor prognosis and may&#xD;
      therefore be important therapeutic targets. The number of patients with infected with COVID-&#xD;
      19 in UK is rapidly rising as with many other European countries. Eventually &gt;50% of people&#xD;
      will have become infected and COVID-19 will remain a public health threat in the long term.&#xD;
      It is therefore very important to understand every aspect of this disease, including the&#xD;
      associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data&#xD;
      from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly&#xD;
      pulmonary embolism (PE), is major problem in COVID patients. In this&#xD;
      retrospective-prospective: multicentre study, investigators will document the patient&#xD;
      characteristics, presenting haematological parameters and associated comorbidities and their&#xD;
      association with bleeding, thrombosis and mortality in patients admitted for hospital&#xD;
      treatment. Determining the predictive value of patient characteristics and presenting&#xD;
      laboratory measurements for clinical outcomes in these patients will allow us to optimise&#xD;
      management of these patients in the future. Furthermore, by comparing these data with data&#xD;
      from patients without Covid-19, investigators will be able to modify existing protocols and&#xD;
      tailor them to the management of COVID -19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">June 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 25, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence and characteristics of coagulation abnormalities and their predictive value for respiratory failure requiring ventilation, multiorgan failure and death in patients presenting with COVID 19 infection</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of respiratory failure requiring CPAP or mechanical ventilation</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of thrombosis (clinical or radiological diagnosis) including thrombosis within 90 days after hospital admission (hospital associated thrombosis) 4. Incidence of minor bleeding 5. Heparin induced thrombocytopenia 6. Acute coronary syndrome</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically relevant non-major bleeding</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Heparin induced thrombocytopenia</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Acute coronary syndrome</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of renal failure requiring renal replacement therapy</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Multiorgan failure</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Development of DIC</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay (days)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>COVID</condition>
  <condition>Thrombosis</condition>
  <condition>Bleeding</condition>
  <condition>Anticoagulation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-interventional</intervention_name>
    <description>Observational study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (&gt;18 years) admitted hospitals with suspected COVID-19 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;18 years) admitted hospitals with COVID 19 infection (COVID RNA+ +/-&#xD;
             radiological change +/- clinical suspicion in absence of RNA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Dr Deepa Jayakody Arachchillage, FRCPath, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr Deepa Jayakody Arachchillage, MRCP, FRCPath, MD</last_name>
    <phone>02073518401</phone>
    <email>d.arachchillage@imperial.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 3, 2022</submitted>
    <returned>February 2, 2023</returned>
  </pending_results>
  <!-- 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/NCT04405232
org study id: 20SM5934
nct id: NCT04405232
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory
      failure [acute respiratory distress syndrome (ARDS)] and death is a global threat. On
      11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there
      are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop
      dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or
      end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged
      Prothrombin time [PT] and raised D dimer) are reported to predict a poor prognosis and may
      therefore be important therapeutic targets. The number of patients with infected with COVID-
      19 in UK is rapidly rising as with many other European countries. Eventually >50% of people
      will have become infected and COVID-19 will remain a public health threat in the long term.
      It is therefore very important to understand every aspect of this disease, including the
      associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data
      from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly
      pulmonary embolism (PE), is major problem in COVID patients. In this
      retrospective-prospective: multicentre study, investigators will document the patient
      characteristics, presenting haematological parameters and associated comorbidities and their
      association with bleeding, thrombosis and mortality in patients admitted for hospital
      treatment. Determining the predictive value of patient characteristics and presenting
      laboratory measurements for clinical outcomes in these patients will allow us to optimise
      management of these patients in the future. Furthermore, by comparing these data with data
      from patients without Covid-19, investigators will be able to modify existing protocols and
      tailor them to the management of COVID -19.
observational model: Cohort
time perspective: Prospective
measure: Prevalence and characteristics of coagulation abnormalities and their predictive value for respiratory failure requiring ventilation, multiorgan failure and death in patients presenting with COVID 19 infection
time frame: 12 months
measure: Incidence of respiratory failure requiring CPAP or mechanical ventilation
time frame: 12 months
measure: Incidence of thrombosis (clinical or radiological diagnosis) including thrombosis within 90 days after hospital admission (hospital associated thrombosis) 4. Incidence of minor bleeding 5. Heparin induced thrombocytopenia 6. Acute coronary syndrome
time frame: 12 months
measure: Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality
time frame: 12 months
measure: Incidence of clinically relevant non-major bleeding
time frame: 12 months
measure: Incidence of Heparin induced thrombocytopenia
time frame: 12 months
measure: Incidence of Acute coronary syndrome
time frame: 12 months
measure: Incidence of renal failure requiring renal replacement therapy
time frame: 12 months
measure: Incidence of Multiorgan failure
time frame: 12 months
measure: Incidence of Development of DIC
time frame: 12 months
measure: Duration of hospital stay (days)
time frame: 12 months
measure: Hospital mortality
time frame: 12 months
intervention type: Other
intervention name: Non-interventional
description: Observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Dr Deepa Jayakody Arachchillage, FRCPath, MD
role: Study Chair
affiliation: Imperial College London
last name: Dr Deepa Jayakody Arachchillage, MRCP, FRCPath, MD
phone: 02073518401
email: d.arachchillage@imperial.ac.uk
facility: 
status: Recruiting
country: United Kingdom
responsible party type: Sponsor
mesh term: Thrombosis
submitted: May 3, 2022
returned: February 2, 2023