<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/NCT04403932</url>
  </required_header>
  <id_info>
    <org_study_id>20/428-E_COVID</org_study_id>
    <nct_id>NCT04403932</nct_id>
  </id_info>
  <brief_title>Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency</brief_title>
  <acronym>COVIT-D</acronym>
  <official_title>Cohort Study to Determine the Association Between Vitamin D Deficiency and Severity of the Disease in Patients With Coronarvirus Disease 2019 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Carlos, Madrid</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>
      In this prospective observational study we aim to study the association of vitamin D&#xD;
      deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin&#xD;
      D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD)&#xD;
      could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased&#xD;
      risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective&#xD;
      cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of&#xD;
      a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and&#xD;
      follow-up obtained. The primary outcome is a composite of death, admission to the intensive&#xD;
      care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The&#xD;
      primary association between VDD - categorised in groups - and the primary outcome will be&#xD;
      evaluated with univariate analyses and multivariable logistic regression including the&#xD;
      following prespecified confounders: age, gender, obesity and chronic kidney disease. The&#xD;
      estimated sample size is n=500 and the expected inclusion time lapse 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2020</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>severe COVID-19</measure>
    <time_frame>17/04/2020 to 01/06/2020</time_frame>
    <description>death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula</description>
  </primary_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Coronavirus Disease 2019 (COVID-19)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adult subjects attending the emergency department with symptoms suggestive of&#xD;
        COVID-19 and a positive reverse-transcriptase polymerase chain reaction for SARS-CoV-2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  symptoms suggestive of COVID-19&#xD;
&#xD;
          -  positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bacterial community acquired pneumonia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Fernando Macaya</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Coronavirus Disease 2019 (COVID-19)</keyword>
  <keyword>Vitamin D Deficiency</keyword>
  <keyword>Severe Acute Respiratory Syndrome</keyword>
  <keyword>Angiotensin Converting Enzyme 2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT04403932
org study id: 20/428-E_COVID
nct id: NCT04403932
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this prospective observational study we aim to study the association of vitamin D
      deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019
Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin
      D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD)
      could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased
      risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective
      cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of
      a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and
      follow-up obtained. The primary outcome is a composite of death, admission to the intensive
      care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The
      primary association between VDD - categorised in groups - and the primary outcome will be
      evaluated with univariate analyses and multivariable logistic regression including the
      following prespecified confounders: age, gender, obesity and chronic kidney disease. The
      estimated sample size is n=500 and the expected inclusion time lapse 3 months.
observational model: Cohort
time perspective: Prospective
measure: severe COVID-19
time frame: 17/04/2020 to 01/06/2020
description: death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Fernando Macaya
investigator title: MD
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Vitamin D Deficiency