<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/NCT04407169</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI081</org_study_id>
    <nct_id>NCT04407169</nct_id>
  </id_info>
  <brief_title>Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease</brief_title>
  <acronym>CRITICoVid</acronym>
  <official_title>Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, 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>
      A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly&#xD;
      spread around the world. To date, the data in the literature regarding the clinical and&#xD;
      epidemiological characteristics of severe forms of CoVid-19 in patients with chronic&#xD;
      respiratory disease are not well known.&#xD;
&#xD;
      The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial&#xD;
      dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome,&#xD;
      obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and&#xD;
      hypoxemia leading to hospitalization for severe forms more frequently than the general&#xD;
      population. However, they do not appear to be more at risk of developing a critical form.&#xD;
&#xD;
      This study is carried out in order to propose to estimate the prevalence of critical forms of&#xD;
      CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">November 17, 2020</completion_date>
  <primary_completion_date type="Actual">November 17, 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>Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale</measure>
    <time_frame>up to 28 days (during hospitalisation)</time_frame>
    <description>Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determined potential predictive factors of critic form in patients with chronic lung diseases</measure>
    <time_frame>up to 28 days (during hospitalisation)</time_frame>
    <description>Radiological damage (extension of ground-glass) could be a predictive factor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determined percentage of death</measure>
    <time_frame>up to 28 days (during hospitalisation)</time_frame>
    <description>intra-hospital death, intra-ICU death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determined duration of oxygen therapy</measure>
    <time_frame>up to 28 days (during hospitalisation)</time_frame>
    <description>in days (or duration at a different flow rate compared to long-term home oxygen therapy prior to hospitalization)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determined duration of hospitalization</measure>
    <time_frame>up to 28 days (during hospitalisation)</time_frame>
    <description>in days for patients with chronic respiratory disease between the date of admission and the date of discharge. Patients who died during hospitalization will be assigned the highest cohort value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine mean values of the WHO CoVid-19 infection progression scale measured</measure>
    <time_frame>up to 28 days (during hospitalisation)</time_frame>
    <description>values will be measured at D3, D7 and D14 in each of the groups. Patients who do not reach D7 and D14 will have the last postponement</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">617</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Patients without chronic respiratory disease</arm_group_label>
    <description>All patients hospitalized for severe CoVid-19 without chronic respiratory disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with chronic respiratory diseas</arm_group_label>
    <description>Patients hospitalized for severe CoVid-19 with one chronic respiratory disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>There will be no intervention. It is only an observationnal study</description>
    <arm_group_label>Patients with chronic respiratory diseas</arm_group_label>
    <arm_group_label>Patients without chronic respiratory disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients hospitalized for severe CoVid-19 with or without chronic respiratory disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years of age&#xD;
&#xD;
          -  Diagnosis of CoVid-2 SARS infection retained (from clinical presentation, radiological&#xD;
             and CoVid-19 positive microbiological specimen).&#xD;
&#xD;
          -  Hospitalisation in the conventional medical sector for &quot;respiratory&quot; reasons (= severe&#xD;
             form of CoVid-19) in the Nancy-Brabois hospital and Metz-Thionville Hospital between&#xD;
             02/03/2020 and 15/06/2020.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of SARS-CoV-2 infection not retained&#xD;
&#xD;
          -  Refusal of the patient to participate in the study&#xD;
&#xD;
          -  Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health&#xD;
             Code: o Pregnant woman, parturient or breastfeeding mother o Minors (not emancipated)&#xD;
             o Persons of full age subject to a legal protection measure (guardianship,&#xD;
             curatorship, safeguard of justice) - Persons of full age unable to express their&#xD;
             consent Persons deprived of their liberty by a judicial or administrative decision,&#xD;
             persons subject to psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.&#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>Valentin Simon</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.</citation>
    <PMID>32109013</PMID>
  </results_reference>
  <results_reference>
    <citation>Fang L, Gao P, Bao H, Tang X, Wang B, Feng Y, Cong S, Juan J, Fan J, Lu K, Wang N, Hu Y, Wang L. Chronic obstructive pulmonary disease in China: a nationwide prevalence study. Lancet Respir Med. 2018 Jun;6(6):421-430. doi: 10.1016/S2213-2600(18)30103-6. Epub 2018 Apr 9.</citation>
    <PMID>29650407</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32171076</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, Akdis CA, Gao YD. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-1741. doi: 10.1111/all.14238. Epub 2020 Feb 27.</citation>
    <PMID>32077115</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 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>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04407169
org study id: 2020PI081
nct id: NCT04407169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly
      spread around the world. To date, the data in the literature regarding the clinical and
      epidemiological characteristics of severe forms of CoVid-19 in patients with chronic
      respiratory disease are not well known.

      The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial
      dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome,
      obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and
      hypoxemia leading to hospitalization for severe forms more frequently than the general
      population. However, they do not appear to be more at risk of developing a critical form.

      This study is carried out in order to propose to estimate the prevalence of critical forms of
      CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.
observational model: Cohort
time perspective: Retrospective
measure: Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale
time frame: up to 28 days (during hospitalisation)
description: Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.
measure: Determined potential predictive factors of critic form in patients with chronic lung diseases
time frame: up to 28 days (during hospitalisation)
description: Radiological damage (extension of ground-glass) could be a predictive factor.
measure: Determined percentage of death
time frame: up to 28 days (during hospitalisation)
description: intra-hospital death, intra-ICU death
measure: Determined duration of oxygen therapy
time frame: up to 28 days (during hospitalisation)
description: in days (or duration at a different flow rate compared to long-term home oxygen therapy prior to hospitalization)
measure: Determined duration of hospitalization
time frame: up to 28 days (during hospitalisation)
description: in days for patients with chronic respiratory disease between the date of admission and the date of discharge. Patients who died during hospitalization will be assigned the highest cohort value.
measure: Determine mean values of the WHO CoVid-19 infection progression scale measured
time frame: up to 28 days (during hospitalisation)
description: values will be measured at D3, D7 and D14 in each of the groups. Patients who do not reach D7 and D14 will have the last postponement
arm group label: Patients without chronic respiratory disease
description: All patients hospitalized for severe CoVid-19 without chronic respiratory disease
arm group label: Patients with chronic respiratory diseas
description: Patients hospitalized for severe CoVid-19 with one chronic respiratory disease
intervention type: Other
intervention name: no intervention
description: There will be no intervention. It is only an observationnal study
arm group label: Patients with chronic respiratory diseas
arm group label: Patients without chronic respiratory disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PMID: 32109013
citation: Fang L, Gao P, Bao H, Tang X, Wang B, Feng Y, Cong S, Juan J, Fan J, Lu K, Wang N, Hu Y, Wang L. Chronic obstructive pulmonary disease in China: a nationwide prevalence study. Lancet Respir Med. 2018 Jun;6(6):421-430. doi: 10.1016/S2213-2600(18)30103-6. Epub 2018 Apr 9.
PMID: 29650407
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32171076
citation: Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, Akdis CA, Gao YD. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-1741. doi: 10.1111/all.14238. Epub 2020 Feb 27.
PMID: 32077115
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: No