<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/NCT04427358</url>
  </required_header>
  <id_info>
    <org_study_id>7838</org_study_id>
    <nct_id>NCT04427358</nct_id>
  </id_info>
  <brief_title>RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population</brief_title>
  <acronym>COVID-19GAOM</acronym>
  <official_title>RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Evaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among&#xD;
      elderly people.&#xD;
&#xD;
      It is unclear how long an individual with COVID-19 will remain &quot;sick&quot; and &quot;contagious&quot;. It&#xD;
      appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course&#xD;
      of the disease.&#xD;
&#xD;
      They investigators did not find any study on a COVID + geriatric population reassessing&#xD;
      carriage at 1 month even though age seems to be a risk factor for prolonged excretion as&#xD;
      suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al.&#xD;
      Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical&#xD;
      Infectious Diseases. 2020 Apr 9; ciaa351&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Actual">September 7, 2020</completion_date>
  <primary_completion_date type="Actual">August 7, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>1. Analysis of the rate of RT-PCR SARS-CoV-2 positive at 1 month of COVID infection</measure>
    <time_frame>at 1 month of COVID infection]</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>2. Assess quantitative evaluation of a nasopharyngeal swab SARS-CoV-2 RT-PCR test</measure>
    <time_frame>at 1 month after COVID infection</time_frame>
    <description>The objective of this study is to quantitatively assess viral shedding in COVID-19 infected elderly patients who survived infection in order to provide an overview of the evolution of nasopharyngeal swab SARS-CoV-2 real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test results with the Cycle threshold value of the RT-PCR test.. The investigatrors analyze nasopharyngeal RT-PCR at diagnosis. After one month since the date of onset symptoms they reassessed survival patients with nasopharyngeal RT-PCR and repeat the RT-PCR at least every week until final negative conversion occurs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of late stool SARS-CoV-2 RT-PCR, serological status and associated factors with death and RT-PCR results 1 month after the date of first symptom onset</measure>
    <time_frame>1 month after the date of first symptom onset</time_frame>
    <description>Assessment of late stool SARS-CoV-2 RT-PCR results one month after the date of onset symptom(dso) (% of patients with a positive fecal RT-PCR test after 1 month)&#xD;
COVID-19 serological status; associated factors with death and RT-PCR results 1 month after the dso: Age (year), gender, Medical history prior to hospilization : Hypertension, diabetes, coronary artery disease, heart failure, atrial fibrillation, chronic respiratory disease, History of medication: ACEI, ARBs Antiplatetet drug, doses of anticoagulant therapy, antibiotic, corticotherapy, statin, Proton pump inhibitor, T°C&gt;37.8 7 days after the onset of symptoms, weight in kg, height in meter combined to report BMI in kg/m^2, Charlson score, Use of adjuvant oxygen, Lung CT-Scan results : extent of lesion &lt;25%/25-50%/50-75%/&gt;75%, Lymphocytes, platelet, CRP count at the time of diagnosis and 7 days after, GFR at diagnosis ml/min /1.73m2, ABO group, Rhesus antibody, Nasopharyngeal RT PCR initial Cycle Threshold</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Covid-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient over 70 years age having COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 70years&#xD;
&#xD;
          -  Patient hospitalized on the geriatric center from March 1, 2020 to August 1, 2020 with&#xD;
             a diagnosis of COVID-19 still alive at 1 month.&#xD;
&#xD;
          -  Patient having agreed to the re-use of their data for the purposes of this research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who expressed his opposition to participate in the study&#xD;
&#xD;
          -  Subject under judicial protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Service SSR Gériatrique</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RT-PCR SARS-CoV-2</keyword>
  <keyword>Covid-19</keyword>
  <keyword>Carriage</keyword>
  <keyword>Viral shredding</keyword>
  <keyword>Elderly</keyword>
  <keyword>Elderly people</keyword>
  <keyword>Geriatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04427358
org study id: 7838
nct id: NCT04427358
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among
      elderly people.

      It is unclear how long an individual with COVID-19 will remain "sick" and "contagious". It
      appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course
      of the disease.

      They investigators did not find any study on a COVID + geriatric population reassessing
      carriage at 1 month even though age seems to be a risk factor for prolonged excretion as
      suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al.
      Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical
      Infectious Diseases. 2020 Apr 9; ciaa351
observational model: Case-Only
time perspective: Other
measure: 1. Analysis of the rate of RT-PCR SARS-CoV-2 positive at 1 month of COVID infection
time frame: at 1 month of COVID infection]
measure: 2. Assess quantitative evaluation of a nasopharyngeal swab SARS-CoV-2 RT-PCR test
time frame: at 1 month after COVID infection
description: The objective of this study is to quantitatively assess viral shedding in COVID-19 infected elderly patients who survived infection in order to provide an overview of the evolution of nasopharyngeal swab SARS-CoV-2 real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test results with the Cycle threshold value of the RT-PCR test.. The investigatrors analyze nasopharyngeal RT-PCR at diagnosis. After one month since the date of onset symptoms they reassessed survival patients with nasopharyngeal RT-PCR and repeat the RT-PCR at least every week until final negative conversion occurs.
measure: Assessment of late stool SARS-CoV-2 RT-PCR, serological status and associated factors with death and RT-PCR results 1 month after the date of first symptom onset
time frame: 1 month after the date of first symptom onset
description: Assessment of late stool SARS-CoV-2 RT-PCR results one month after the date of onset symptom(dso) (% of patients with a positive fecal RT-PCR test after 1 month)
COVID-19 serological status; associated factors with death and RT-PCR results 1 month after the dso: Age (year), gender, Medical history prior to hospilization : Hypertension, diabetes, coronary artery disease, heart failure, atrial fibrillation, chronic respiratory disease, History of medication: ACEI, ARBs Antiplatetet drug, doses of anticoagulant therapy, antibiotic, corticotherapy, statin, Proton pump inhibitor, T°C>37.8 7 days after the onset of symptoms, weight in kg, height in meter combined to report BMI in kg/m^2, Charlson score, Use of adjuvant oxygen, Lung CT-Scan results : extent of lesion <25%/25-50%/50-75%/>75%, Lymphocytes, platelet, CRP count at the time of diagnosis and 7 days after, GFR at diagnosis ml/min /1.73m2, ABO group, Rhesus antibody, Nasopharyngeal RT PCR initial Cycle Threshold
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19