<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/NCT04402905</url>
  </required_header>
  <id_info>
    <org_study_id>CREPATS 011</org_study_id>
    <nct_id>NCT04402905</nct_id>
  </id_info>
  <brief_title>Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL)</brief_title>
  <acronym>COVID-PSL</acronym>
  <official_title>Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida</source>
  <oversight_info>
    <has_dmc>Yes</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>
      COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in&#xD;
      China at the end of 2019, and which has since spread around the world, responsible for a new&#xD;
      major pandemic, which is upsetting the whole world.&#xD;
&#xD;
      If severe respiratory disease is the form that constitutes the extreme gravity of the disease&#xD;
      (mortality, with more than 170,000 deaths worldwide to date).&#xD;
&#xD;
      However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic&#xD;
      pauci forms, moderate forms, up to severe forms.&#xD;
&#xD;
      Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms,&#xD;
      anosmia and / or ageusia, skin involvement, etc.&#xD;
&#xD;
      Given the novelty of this infection, several questions remain:&#xD;
&#xD;
        -  What are all the symptoms that can be contracted by a COVID-19 patient?&#xD;
&#xD;
        -  Are there clinical forms not described?&#xD;
&#xD;
        -  What is the evolutionary profile, the healing time of this disease in patients treated&#xD;
           on an outpatient basis?&#xD;
&#xD;
        -  What are the factors associated with a prolonged form of COVID-19 disease, including on&#xD;
           an outpatient basis?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most of the descriptive studies relating to COVID-19 relate to the severe forms of the&#xD;
      disease managed in the hospital sector.&#xD;
&#xD;
      Few data have been published on moderate forms, requiring no hospitalization, of strict&#xD;
      outpatient management.&#xD;
&#xD;
      These so-called moderate forms, however, constitute the majority of cases of COVID-19&#xD;
      (approximately 80%).&#xD;
&#xD;
      In the Infectious and Tropical Diseases Department of Pitie Salpetriere, COVIDOM pilot site,&#xD;
      at the beginning of March, during the intensification of the epidemic in France, a weekly&#xD;
      telephone consultation was set up to take care of people tested for COVID + by PCR, or people&#xD;
      not tested by PCR, or even tested with negative PCR but symptomatic and followed at home,&#xD;
      suffering from moderate form of COVID-19, as well as their contact cases if they wished.&#xD;
&#xD;
      Telemedicine is particularly suitable in this epidemic context, ensuring continuity of care,&#xD;
      while limiting face-to-face consultations, thus reducing the risk of cross-contamination.&#xD;
&#xD;
      Given the novelty of this infection, it is important to be able to best characterize these&#xD;
      ambulatory forms, as well as their evolution, in order to manage these patients, and to offer&#xD;
      primary care physicians a more detailed description of these forms. , which they are and will&#xD;
      be called upon to take care of, general medicine being central to dealing with the epidemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 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>COVID-PSL Cohort</measure>
    <time_frame>3 months</time_frame>
    <description>measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30</description>
  </primary_outcome>
  <enrollment type="Actual">450</enrollment>
  <condition>Coronavirus Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Enrolment will be done from the active queue of patients included in the COVIDOM / PSL&#xD;
        platform.&#xD;
&#xD;
        This study will be a monocentric data collection. The patient is called, on working days,&#xD;
        weekly from D0 to D30, and beyond if the symptoms persist on D30.&#xD;
&#xD;
        Data will be collected at D0, D7, D14, D21 and D30. The visit on D30 corresponds to the end&#xD;
        of the systematic weekly telephone interviews if the patient has reached complete recovery,&#xD;
        defined by the absence of symptoms for 3 days.&#xD;
&#xD;
        If the symptoms persist on D30: monitoring is continued, on D45 and D60, and beyond if&#xD;
        necessary.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  COVID PCR + patient: Patient screened positive by PCR on nasopharyngeal swab&#xD;
&#xD;
          -  or COVID-like patient: Patient not screened, but considered COVID + because contact&#xD;
             with a COVID PCR + person, and presenting symptoms suggestive of COVID-19 among:&#xD;
&#xD;
          -  Influenza-like illness (fever, body aches, arthralgia, etc.)&#xD;
&#xD;
          -  Respiratory form: dyspnea, cough, rhinitis&#xD;
&#xD;
          -  Gastrointestinal form: diarrhea, nausea, vomiting&#xD;
&#xD;
          -  Anosmia and / or ageusia&#xD;
&#xD;
          -  or patient COVID PCR-: If patient tested negative by PCR on nasopharyngeal swab, but&#xD;
             showing signs suggestive of COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient objecting to the use of their data for research purposes&#xD;
&#xD;
          -  Patient under justice or deprived of liberty.&#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>Christine Katlama, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pitie-Salpetriere Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yasmine Dudoit</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</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/NCT04402905
org study id: CREPATS 011
nct id: NCT04402905
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in
      China at the end of 2019, and which has since spread around the world, responsible for a new
      major pandemic, which is upsetting the whole world.

      If severe respiratory disease is the form that constitutes the extreme gravity of the disease
      (mortality, with more than 170,000 deaths worldwide to date).

      However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic
      pauci forms, moderate forms, up to severe forms.

      Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms,
      anosmia and / or ageusia, skin involvement, etc.

      Given the novelty of this infection, several questions remain:

        -  What are all the symptoms that can be contracted by a COVID-19 patient?

        -  Are there clinical forms not described?

        -  What is the evolutionary profile, the healing time of this disease in patients treated
           on an outpatient basis?

        -  What are the factors associated with a prolonged form of COVID-19 disease, including on
           an outpatient basis?
Most of the descriptive studies relating to COVID-19 relate to the severe forms of the
      disease managed in the hospital sector.

      Few data have been published on moderate forms, requiring no hospitalization, of strict
      outpatient management.

      These so-called moderate forms, however, constitute the majority of cases of COVID-19
      (approximately 80%).

      In the Infectious and Tropical Diseases Department of Pitie Salpetriere, COVIDOM pilot site,
      at the beginning of March, during the intensification of the epidemic in France, a weekly
      telephone consultation was set up to take care of people tested for COVID + by PCR, or people
      not tested by PCR, or even tested with negative PCR but symptomatic and followed at home,
      suffering from moderate form of COVID-19, as well as their contact cases if they wished.

      Telemedicine is particularly suitable in this epidemic context, ensuring continuity of care,
      while limiting face-to-face consultations, thus reducing the risk of cross-contamination.

      Given the novelty of this infection, it is important to be able to best characterize these
      ambulatory forms, as well as their evolution, in order to manage these patients, and to offer
      primary care physicians a more detailed description of these forms. , which they are and will
      be called upon to take care of, general medicine being central to dealing with the epidemic.
observational model: Cohort
time perspective: Retrospective
measure: COVID-PSL Cohort
time frame: 3 months
description: measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Katlama, MD
role: Principal Investigator
affiliation: Pitie-Salpetriere Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Coronavirus Infections