<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/NCT04438993</url>
  </required_header>
  <id_info>
    <org_study_id>COVI-RW-2020</org_study_id>
    <nct_id>NCT04438993</nct_id>
  </id_info>
  <brief_title>The COVID-19 Disease and CARdiac Events Study</brief_title>
  <acronym>COVICARE</acronym>
  <official_title>An Observational Study of Hospitalised Patients With Coronavirus Disease 2019 (COVID-19) to Determine the Degree of Myocardial Injury Using Biomarkers and Echocardiography, and the Impact of This on Cardiovascular Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Lanarkshire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NHS Lanarkshire</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>
      An observational study of consecutive patients testing positive for COVID-19 who require&#xD;
      admission to hospital to determine the degree of myocardial injury through biomarkers and&#xD;
      echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and&#xD;
      CARdiac Events study (COVICARE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purposes:&#xD;
&#xD;
        1. To determine the prevalence of myocardial injury/impairment in patients hospitalised&#xD;
           with COVID-19 disease.&#xD;
&#xD;
        2. To determine the predictive value of baseline biomarkers in identifying patients at high&#xD;
           risk of significant morbidity/mortality due to COVID-19.&#xD;
&#xD;
      Justification:&#xD;
&#xD;
      The Novel Coronavirus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), first&#xD;
      recorded in Hubei Province of Wuhan China in December 2019 has now swept the globe and has&#xD;
      been declared a pandemic by the World Health Organisation.&#xD;
&#xD;
      The largest published registry from the Chinese centre for disease control and prevention&#xD;
      (CDC) describes a disease with a broad range of acuity but found from a cohort of 72314&#xD;
      confirmed or suspected cases (72314) 14% of those affected required hospitalisation and 5%&#xD;
      required critical care. Thus far treatment has focused on quarantine and supportive care.&#xD;
&#xD;
      Predicting outcomes in COVID disease requires risk stratifying infected patients. Data so far&#xD;
      have mainly come from small studies in China but the consistent risk factors appear to be&#xD;
      advanced age, diabetes, hypertension and cardiovascular disease. The CDC report a 10.5% risk&#xD;
      of death associated with underlying cardiovascular disease, surprisingly more than those with&#xD;
      respiratory disease, especially given that lung involvement is the dominant clinical&#xD;
      presentation. The reason for poor outcome in cardiovascular disease is unknown but is likely&#xD;
      to be multifactorial. A literature search of nine observational studies reported myocardial&#xD;
      injury based on high sensitivity troponin, abnormal ECG, abnormal echocardiogram or a&#xD;
      combination of the three. The reported rate of myocardial injury ranged from 7-28% and in all&#xD;
      groups was associated with higher rates of requirement for critical care. Mortality was&#xD;
      increased compared to those without myocardial injury- 51.2% vs 4.5%.&#xD;
&#xD;
      Trial overview:&#xD;
&#xD;
      Patients admitted to University Hospital Hairmyres (UHH) with confirmed COVID-19 will have 3&#xD;
      biomarkers - high sensitivity troponin T (hsTnT), N-terminal (NT)-proBNP and ferritin - added&#xD;
      on retrospectively to their admission blood samples, and an additional sample will be taken&#xD;
      for cytokine analysis.&#xD;
&#xD;
      An ECG and echocardiogram will be performed.&#xD;
&#xD;
      Patients will be observed during the remainder of the hospitalisation and for up to 30 days&#xD;
      from admission for major adverse cardiac events.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The prevalence of echocardiographic abnormalities in the cohort will be presented.&#xD;
&#xD;
      Biomarker levels will be compared between patients who require intensive treatment unit (ITU)&#xD;
      admission or not, ventilation or not or who die or survive up to 30 days using independent&#xD;
      samples t-tests if the data are normally distributed or Mann-Whitney-U tests if non normally&#xD;
      distributed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Actual">January 29, 2021</completion_date>
  <primary_completion_date type="Actual">January 29, 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>Cardiac abnormalities in COVID-19 disease in-patients</measure>
    <time_frame>6 months</time_frame>
    <description>The primary objective of this study is to characterise the prevalence of myocardial injury and cardiac dysfunction in patients hospitalised with COVID-19 disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarker - hsTnT</measure>
    <time_frame>30 days</time_frame>
    <description>To compare levels of hsTnT in ng/L between patients who experience an adverse event and those who do not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker - NT-proBNP</measure>
    <time_frame>30 days</time_frame>
    <description>To compare levels of NT-proBNP in pg/ml between patients who experience an adverse event and those who do not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker - ferritin</measure>
    <time_frame>30 days</time_frame>
    <description>To compare levels of ferritin in ug/L between patients who experience an adverse event and those who do not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker - cytokines</measure>
    <time_frame>30 days</time_frame>
    <description>To compare levels of cytokines in pg/mL between patients who experience an adverse event and those who do not.</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>COVID</condition>
  <condition>Coronavirus</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Venous blood plasma retained for future analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We plan to enrol all consecutive admissions with COVID-19 disease admitted to UHH up until&#xD;
        a maximal target of 100 patients have been recruited. Patients will have a positive real&#xD;
        time reverse transcription (rt)PCR for SARS-CoV-2 nasopharyngeal swab and/or chest X-ray or&#xD;
        CT imaging showing classical COVID-19 disease abnormalities ('classic/probable COVID-19,&#xD;
        mild/mod or severe' according to current British Society of Thoracic Imaging guidance, and&#xD;
        be within 5 days of admission (so as to enable us to retrospectively add on biomarkers to&#xD;
        blood samples sent on admission to hospital).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. In-patient in UHH within first 5 days of admission&#xD;
&#xD;
          3. COVID-19 disease confirmed on rtPCR detection of SARS-CoV-2 from nasopharyngeal swabs&#xD;
             and/or thoracic X-ray imaging findings characteristic of COVID-19 disease (positive&#xD;
             swab results preferred).&#xD;
&#xD;
          4. Able to provide written, informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Refusal of consent for enrolment.&#xD;
&#xD;
          2. Known pre-existing left ventricular systolic dysfunction with left ventricular&#xD;
             ejection fraction (LVEF) &lt;40%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin A Weir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Lanarkshire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Hairmyres</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G75 8RG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Echocardiogram</keyword>
  <keyword>Troponin</keyword>
  <keyword>NT-proBNP</keyword>
  <keyword>Cytokines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04438993
org study id: COVI-RW-2020
nct id: NCT04438993
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An observational study of consecutive patients testing positive for COVID-19 who require
      admission to hospital to determine the degree of myocardial injury through biomarkers and
      echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and
      CARdiac Events study (COVICARE).
Purposes:

        1. To determine the prevalence of myocardial injury/impairment in patients hospitalised
           with COVID-19 disease.

        2. To determine the predictive value of baseline biomarkers in identifying patients at high
           risk of significant morbidity/mortality due to COVID-19.

      Justification:

      The Novel Coronavirus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), first
      recorded in Hubei Province of Wuhan China in December 2019 has now swept the globe and has
      been declared a pandemic by the World Health Organisation.

      The largest published registry from the Chinese centre for disease control and prevention
      (CDC) describes a disease with a broad range of acuity but found from a cohort of 72314
      confirmed or suspected cases (72314) 14% of those affected required hospitalisation and 5%
      required critical care. Thus far treatment has focused on quarantine and supportive care.

      Predicting outcomes in COVID disease requires risk stratifying infected patients. Data so far
      have mainly come from small studies in China but the consistent risk factors appear to be
      advanced age, diabetes, hypertension and cardiovascular disease. The CDC report a 10.5% risk
      of death associated with underlying cardiovascular disease, surprisingly more than those with
      respiratory disease, especially given that lung involvement is the dominant clinical
      presentation. The reason for poor outcome in cardiovascular disease is unknown but is likely
      to be multifactorial. A literature search of nine observational studies reported myocardial
      injury based on high sensitivity troponin, abnormal ECG, abnormal echocardiogram or a
      combination of the three. The reported rate of myocardial injury ranged from 7-28% and in all
      groups was associated with higher rates of requirement for critical care. Mortality was
      increased compared to those without myocardial injury- 51.2% vs 4.5%.

      Trial overview:

      Patients admitted to University Hospital Hairmyres (UHH) with confirmed COVID-19 will have 3
      biomarkers - high sensitivity troponin T (hsTnT), N-terminal (NT)-proBNP and ferritin - added
      on retrospectively to their admission blood samples, and an additional sample will be taken
      for cytokine analysis.

      An ECG and echocardiogram will be performed.

      Patients will be observed during the remainder of the hospitalisation and for up to 30 days
      from admission for major adverse cardiac events.

      Statistical analysis:

      The prevalence of echocardiographic abnormalities in the cohort will be presented.

      Biomarker levels will be compared between patients who require intensive treatment unit (ITU)
      admission or not, ventilation or not or who die or survive up to 30 days using independent
      samples t-tests if the data are normally distributed or Mann-Whitney-U tests if non normally
      distributed.
observational model: Cohort
time perspective: Prospective
measure: Cardiac abnormalities in COVID-19 disease in-patients
time frame: 6 months
description: The primary objective of this study is to characterise the prevalence of myocardial injury and cardiac dysfunction in patients hospitalised with COVID-19 disease.
measure: Biomarker - hsTnT
time frame: 30 days
description: To compare levels of hsTnT in ng/L between patients who experience an adverse event and those who do not.
measure: Biomarker - NT-proBNP
time frame: 30 days
description: To compare levels of NT-proBNP in pg/ml between patients who experience an adverse event and those who do not.
measure: Biomarker - ferritin
time frame: 30 days
description: To compare levels of ferritin in ug/L between patients who experience an adverse event and those who do not.
measure: Biomarker - cytokines
time frame: 30 days
description: To compare levels of cytokines in pg/mL between patients who experience an adverse event and those who do not.
Venous blood plasma retained for future analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robin A Weir, MD
role: Principal Investigator
affiliation: NHS Lanarkshire
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Coronavirus Infections
sharing ipd: No