<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/NCT04435119</url>
  </required_header>
  <id_info>
    <org_study_id>2020/67</org_study_id>
    <nct_id>NCT04435119</nct_id>
  </id_info>
  <brief_title>Covid-19 and Vitamin D in Nursing-home</brief_title>
  <acronym>COVIT-EHPAD</acronym>
  <official_title>COvid-19 et VITamine d en EHPAD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      First epidemiological data about COVID-19 pandemic confirm that older adults are likely to&#xD;
      experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly&#xD;
      living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as&#xD;
      indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological&#xD;
      observational data are necessary for better understanding the links between vitamin D&#xD;
      supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of&#xD;
      hypovitaminosis D is very high).&#xD;
&#xD;
      The investigators had the opportunity to use information collected in a French middle-sized&#xD;
      nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3&#xD;
      supplementation was associated with the prognosis of COVID-19 in residents infected with&#xD;
      SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and&#xD;
      regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on&#xD;
      residents).&#xD;
&#xD;
      The main objective of this study is to determine whether bolus vitamin D3 supplementation&#xD;
      taken during or in the month before COVID-19 was effective in improving survival among frail&#xD;
      elderly nursing-home residents infected with COVID-19 compared to those having received&#xD;
      supplementation longer ago.&#xD;
&#xD;
      The secondary objective is to determine whether bolus vitamin D3 supplementation taken during&#xD;
      or in the month before COVID-19 was effective in limiting the clinical severity of the&#xD;
      infection according to the World Health Organization's Ordinal Scale for Clinical Improvement&#xD;
      (OSCI) for COVID-19 compared to those having received supplementation longer ago.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective observational unicentric study in nursing-home residents with COVID-19. Health&#xD;
      status monitoring data available until May 15, 2020. For all participants, gender, age,&#xD;
      disability, history and comorbidities, treatments, date of last vitamin D3 supplementation,&#xD;
      results of last blood test, date of suspicion / diagnosis of COVID-19, COVID-19 OSCI score,&#xD;
      and eventual hospitalization or death (surveillance data available until May 15, 2020) are&#xD;
      collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of deaths of any cause in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19</measure>
    <time_frame>From March 2020 to 15 May 2020</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical severity score of COVID19 in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19</measure>
    <time_frame>From March 2020 to 15 May 2020</time_frame>
    <description>Clinical severity score of COVID19 is assessed with Ordinal Scale for Clinical Improvement (OSCI). OSCI ranges from 0 to 8, higher score meaning poorer outcome.</description>
  </secondary_outcome>
  <enrollment type="Actual">96</enrollment>
  <condition>Coronavirus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All residents in the nursing-home of Saint Laurent-de-Chamousset, France, during the&#xD;
        COVID-19 epidemic (March-April 2020) This residents are suspected or diagnosed with&#xD;
        COVID-19 (RT-PCR, chest CT scan)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in the nursing-home of Saint Laurent-de-Chamousset, France, during the COVID-19&#xD;
             epidemic (March-April 2020)&#xD;
&#xD;
          -  Being suspected or diagnosed with COVID-19 (RT-PCR, chest CT scan)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Opposition of the resident and/or relatives to the use of anonymized clinical-biological&#xD;
        data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cédric ANNWEILER, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angers University Hospital</name>
      <address>
        <city>Angers</city>
        <zip>49933 cedex 9</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 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>Coronavirus Infections</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/NCT04435119
org study id: 2020/67
nct id: NCT04435119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
First epidemiological data about COVID-19 pandemic confirm that older adults are likely to
      experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly
      living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as
      indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological
      observational data are necessary for better understanding the links between vitamin D
      supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of
      hypovitaminosis D is very high).

      The investigators had the opportunity to use information collected in a French middle-sized
      nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3
      supplementation was associated with the prognosis of COVID-19 in residents infected with
      SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and
      regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on
      residents).

      The main objective of this study is to determine whether bolus vitamin D3 supplementation
      taken during or in the month before COVID-19 was effective in improving survival among frail
      elderly nursing-home residents infected with COVID-19 compared to those having received
      supplementation longer ago.

      The secondary objective is to determine whether bolus vitamin D3 supplementation taken during
      or in the month before COVID-19 was effective in limiting the clinical severity of the
      infection according to the World Health Organization's Ordinal Scale for Clinical Improvement
      (OSCI) for COVID-19 compared to those having received supplementation longer ago.
Retrospective observational unicentric study in nursing-home residents with COVID-19. Health
      status monitoring data available until May 15, 2020. For all participants, gender, age,
      disability, history and comorbidities, treatments, date of last vitamin D3 supplementation,
      results of last blood test, date of suspicion / diagnosis of COVID-19, COVID-19 OSCI score,
      and eventual hospitalization or death (surveillance data available until May 15, 2020) are
      collected.
observational model: Cohort
time perspective: Retrospective
measure: Number of deaths of any cause in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19
time frame: From March 2020 to 15 May 2020
measure: Clinical severity score of COVID19 in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19
time frame: From March 2020 to 15 May 2020
description: Clinical severity score of COVID19 is assessed with Ordinal Scale for Clinical Improvement (OSCI). OSCI ranges from 0 to 8, higher score meaning poorer outcome.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Cédric ANNWEILER, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Angers
facility: 
country: France
responsible party type: Sponsor
mesh term: Coronavirus Infections