<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/NCT04437719</url>
  </required_header>
  <id_info>
    <org_study_id>OBVIONCO</org_study_id>
    <nct_id>NCT04437719</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group for a Period of 6 Months During the COVID-19 Pandemic</brief_title>
  <acronym>OBVIONCO</acronym>
  <official_title>Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ObvioHealth</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      This registry will allow to evaluate the correlation of the incidence and evolution of&#xD;
      associated symptoms of infection of COVID-19 with the biological and clinical parameters in&#xD;
      patients followed in Oncology during the COVID-19 pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to conducting any of the screening tests, the Investigator or his designee will explain&#xD;
      the trial fully to the prospective patient and provide him with a copy of the Patient&#xD;
      Information Leaflet/Informed Consent Form.&#xD;
&#xD;
      If the patient is willing to participate to the trial, his given oral, free, informed and&#xD;
      express consent will be collected and traced in his medical file.&#xD;
&#xD;
      The screening questionnaire will be completed. The patient's suitability for the trial will&#xD;
      be confirmed by the inclusion/exclusion criteria .&#xD;
&#xD;
      Following completion of the Baseline Questionnaire, patients will receive the Daily&#xD;
      Questionnaire. This is designed to assess if they have developed symptoms associated with&#xD;
      COVID-19 infection.&#xD;
&#xD;
      If a participant responds that they are not feeling well, a series of follow-up questions&#xD;
      will be asked regarding what symptoms they are currently experiencing.&#xD;
&#xD;
      The Daily Questionnaire will be asked of patients every day throughout the Observation Period&#xD;
      of 6 months.&#xD;
&#xD;
      At the end of the Observation Period, all patients will complete a series of questionnaires&#xD;
      relating to the conduct of the study and tools employed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">June 3, 2022</completion_date>
  <primary_completion_date type="Actual">June 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COVID-19 infection's symptoms</measure>
    <time_frame>Observational period of 6 months</time_frame>
    <description>Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and course of symptoms of COVID-19 infection</measure>
    <time_frame>During a period of 6 months</time_frame>
    <description>To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the COVID-19 infection with the biological and clinical data of patients</measure>
    <time_frame>After a period of 6 months</time_frame>
    <description>To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Oncology</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Obvio-19 App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file. After enrollment, patients will be sent an invitation via email to download the Obvio-19 mobile app. After downloading the Obvio-19 app, patients will receive instructions as to how they may communicate with the study investigator. Communication may occur through the chat function of the app or live telephone conversations.&#xD;
Patients must log into the Obvio-19 app daily to complete the questionnaires. The Obvio-19 system is designed to identify responses that indicate the participant is at an increased risk for serious illness or exhibiting serious symptoms, such as coughing up blood. Such patients will be notified by the app of this status and prompted to seek medical attention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Obvio-19 app</intervention_name>
    <description>As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.&#xD;
Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.&#xD;
To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.&#xD;
To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.</description>
    <arm_group_label>Obvio-19 App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years of age&#xD;
&#xD;
          -  Patient followed in the medical oncology department of Paris Saint-Joseph Hospital&#xD;
             Paris in France&#xD;
&#xD;
          -  Patient Having regular access to smartphone and internet sufficient to support study&#xD;
             demands&#xD;
&#xD;
          -  French-speaking patient&#xD;
&#xD;
          -  Affiliation to the social security network&#xD;
&#xD;
          -  Willing and able to provide given oral, free, informed and express consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable or unwilling to perform all requested study tasks&#xD;
&#xD;
          -  Patient under tutorship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Pregnant or lactating patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Raymond, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/books/NBK554776/</url>
    <description>Features, Evaluation and Treatment Coronavirus (COVID-19) Marco Cascella; Michael Rajnik; Arturo Cuomo; Scott C. Dulebohn; Raffaela Di Napoli.</description>
  </link>
  <results_reference>
    <citation>Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.</citation>
    <PMID>32007143</PMID>
  </results_reference>
  <results_reference>
    <citation>Gliklich RE, Dreyer NA, Leavy MB, Christian JB, editors. 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition, Addendum [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Mar. Report No.: 17(18)-EHC013-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK493818/</citation>
    <PMID>29708678</PMID>
  </results_reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</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>COVID-19</mesh_term>
    <mesh_term>Neoplasms</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/NCT04437719
org study id: OBVIONCO
nct id: NCT04437719
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This registry will allow to evaluate the correlation of the incidence and evolution of
      associated symptoms of infection of COVID-19 with the biological and clinical parameters in
      patients followed in Oncology during the COVID-19 pandemic.
Prior to conducting any of the screening tests, the Investigator or his designee will explain
      the trial fully to the prospective patient and provide him with a copy of the Patient
      Information Leaflet/Informed Consent Form.

      If the patient is willing to participate to the trial, his given oral, free, informed and
      express consent will be collected and traced in his medical file.

      The screening questionnaire will be completed. The patient's suitability for the trial will
      be confirmed by the inclusion/exclusion criteria .

      Following completion of the Baseline Questionnaire, patients will receive the Daily
      Questionnaire. This is designed to assess if they have developed symptoms associated with
      COVID-19 infection.

      If a participant responds that they are not feeling well, a series of follow-up questions
      will be asked regarding what symptoms they are currently experiencing.

      The Daily Questionnaire will be asked of patients every day throughout the Observation Period
      of 6 months.

      At the end of the Observation Period, all patients will complete a series of questionnaires
      relating to the conduct of the study and tools employed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.
primary purpose: Other
masking: None (Open Label)
measure: COVID-19 infection's symptoms
time frame: Observational period of 6 months
description: Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.
measure: Incidence and course of symptoms of COVID-19 infection
time frame: During a period of 6 months
description: To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.
measure: Correlation of the COVID-19 infection with the biological and clinical data of patients
time frame: After a period of 6 months
description: To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.
arm group label: Obvio-19 App
arm group type: Experimental
description: If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file. After enrollment, patients will be sent an invitation via email to download the Obvio-19 mobile app. After downloading the Obvio-19 app, patients will receive instructions as to how they may communicate with the study investigator. Communication may occur through the chat function of the app or live telephone conversations.
Patients must log into the Obvio-19 app daily to complete the questionnaires. The Obvio-19 system is designed to identify responses that indicate the participant is at an increased risk for serious illness or exhibiting serious symptoms, such as coughing up blood. Such patients will be notified by the app of this status and prompted to seek medical attention.
intervention type: Other
intervention name: Obvio-19 app
description: As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.
Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.
To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.
To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.
arm group label: Obvio-19 App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Raymond, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
facility: 
country: France
url: https://www.ncbi.nlm.nih.gov/books/NBK554776/
description: Features, Evaluation and Treatment Coronavirus (COVID-19) Marco Cascella; Michael Rajnik; Arturo Cuomo; Scott C. Dulebohn; Raffaela Di Napoli.
citation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PMID: 32007143
citation: Gliklich RE, Dreyer NA, Leavy MB, Christian JB, editors. 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition, Addendum [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Mar. Report No.: 17(18)-EHC013-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK493818/
PMID: 29708678
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Neoplasms