<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/NCT04407156</url>
  </required_header>
  <id_info>
    <org_study_id>UHDB/2020/050</org_study_id>
    <nct_id>NCT04407156</nct_id>
  </id_info>
  <brief_title>Epidemiology of Acute Kidney Injury in COVID19 Disease in United Kingdom</brief_title>
  <official_title>Acute Kidney Injury In Corona Virus Infection Disease (COVID19) in United Kingdom</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals of Derby and Burton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals of Derby and Burton 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>
      Severe Acute respiratory syndrome coronovirus (SARS-CoV-2) was first described in Wuhan in&#xD;
      December 2019. It quickly spread to rest of the world and was declared pandemic by World&#xD;
      health organisation. Initial case series focused on lung involvement in the form alveolar&#xD;
      haemorrhages and respiratory failure. However, subsequently, there have been reports of&#xD;
      kidney involvement resulting in severe acute kidney injury. However, the reported incidence&#xD;
      from Chinese data has been less than 5% and detailed epidemiology of AKI in COVID-19 disease&#xD;
      is lacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On 31st December 2019, a cluster of pneumonia cases were detected in Hubei province of China&#xD;
      where the cause was unclear. The cause for these cases was subsequently identified as a virus&#xD;
      which was referred to as SARS-CoV-2, and the associated disease as COVID-19.This evolved&#xD;
      rapidly into a global pandemic with first case reported in UK as early as on 30th January&#xD;
      2020. As of 30th April 2020, there have been 3.05 million laboratory confirmed cases&#xD;
      world-wide with 161,145 cases in United Kingdom (UK) in 539,768 cases tested for COVID-19.&#xD;
      The epidemiology of COVID-19 has differed in China, US and Italy which have different&#xD;
      demographic characteristics, testing methods and different ways to curb the spread of&#xD;
      infection which can be altered by many things, including behaviour, and the stringent social&#xD;
      distancing measure.Though the pandemic started in China, as of 30th April 2020, it has&#xD;
      reported only 58.32 cases per million people (pmp) as compared to United kingdom which has&#xD;
      reported 2433.8 cases pmp. This has resulted in different epidemiology of COVID-19 and organ&#xD;
      system involvement. Lung involvement in the form of alveolar haemorrhages and respiratory&#xD;
      failure has been well document in patients with COVID-19 and has been focus of attention,&#xD;
      however, other organs are also affected in COVID-19, but there has been limited information&#xD;
      kidney involvement in COVID patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 7, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Acute kidney injury in COVID-19</measure>
    <time_frame>7 days</time_frame>
    <description>This is the proportion of patients with Acute kidney injury in COVID-19</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality in AKI patients</measure>
    <time_frame>7 days</time_frame>
    <description>This is the number of deaths in COVID-19 AKI patients</description>
  </secondary_outcome>
  <enrollment type="Actual">724</enrollment>
  <condition>COVID</condition>
  <condition>AKI</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acute kidney injury</intervention_name>
    <description>AKI in COVID positive cases</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is hospitalised patients suspected to have SARS CoV-2 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients who are admitted to the hospital with suspected COVID-19 infection between 1st&#xD;
        March 2020 and 8th May 2020 and who meet following criteria will be included&#xD;
&#xD;
          1. Adult patients greater or equal to 18 years of age.&#xD;
&#xD;
          2. Swab results available for SARS CoV-19&#xD;
&#xD;
          3. Patients admitted to the hospital as per the national screening criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The following patients will be excluded from the study&#xD;
&#xD;
          1. Paediatric patients as defined by age of &lt;18 years of age&#xD;
&#xD;
          2. Swab results which are awaited&#xD;
&#xD;
          3. Patients on haemodialysis or peritoneal dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nitin V Kolhe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals of Derby and Burton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Derby Hospital NHS Foundation Trust</name>
      <address>
        <city>Derby</city>
        <state>Derbyshire</state>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 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>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The results will be shared with other researchers</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>October 6, 2020</submitted>
    <returned>October 16, 2020</returned>
    <submitted>December 15, 2020</submitted>
    <returned>January 7, 2021</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/NCT04407156
org study id: UHDB/2020/050
nct id: NCT04407156
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe Acute respiratory syndrome coronovirus (SARS-CoV-2) was first described in Wuhan in
      December 2019. It quickly spread to rest of the world and was declared pandemic by World
      health organisation. Initial case series focused on lung involvement in the form alveolar
      haemorrhages and respiratory failure. However, subsequently, there have been reports of
      kidney involvement resulting in severe acute kidney injury. However, the reported incidence
      from Chinese data has been less than 5% and detailed epidemiology of AKI in COVID-19 disease
      is lacking.
On 31st December 2019, a cluster of pneumonia cases were detected in Hubei province of China
      where the cause was unclear. The cause for these cases was subsequently identified as a virus
      which was referred to as SARS-CoV-2, and the associated disease as COVID-19.This evolved
      rapidly into a global pandemic with first case reported in UK as early as on 30th January
      2020. As of 30th April 2020, there have been 3.05 million laboratory confirmed cases
      world-wide with 161,145 cases in United Kingdom (UK) in 539,768 cases tested for COVID-19.
      The epidemiology of COVID-19 has differed in China, US and Italy which have different
      demographic characteristics, testing methods and different ways to curb the spread of
      infection which can be altered by many things, including behaviour, and the stringent social
      distancing measure.Though the pandemic started in China, as of 30th April 2020, it has
      reported only 58.32 cases per million people (pmp) as compared to United kingdom which has
      reported 2433.8 cases pmp. This has resulted in different epidemiology of COVID-19 and organ
      system involvement. Lung involvement in the form of alveolar haemorrhages and respiratory
      failure has been well document in patients with COVID-19 and has been focus of attention,
      however, other organs are also affected in COVID-19, but there has been limited information
      kidney involvement in COVID patients.
observational model: Case-Control
time perspective: Retrospective
measure: Incidence of Acute kidney injury in COVID-19
time frame: 7 days
description: This is the proportion of patients with Acute kidney injury in COVID-19
measure: All-cause mortality in AKI patients
time frame: 7 days
description: This is the number of deaths in COVID-19 AKI patients
intervention type: Other
intervention name: acute kidney injury
description: AKI in COVID positive cases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: Nitin V Kolhe, MD
role: Principal Investigator
affiliation: University Hospitals of Derby and Burton
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Acute Kidney Injury
sharing ipd: No
ipd description: The results will be shared with other researchers
submitted: October 6, 2020
returned: October 16, 2020
submitted: December 15, 2020
returned: January 7, 2021