<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/NCT04481633</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0186</org_study_id>
    <secondary_id>2020-A01906-33</secondary_id>
    <nct_id>NCT04481633</nct_id>
  </id_info>
  <brief_title>Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection</brief_title>
  <acronym>PREPCOV</acronym>
  <official_title>Real-life Evaluation of the Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection in Patients Receiving Long-term Treatment for Systemic Lupus Erythematosus and/or Gougerot's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or&#xD;
      prophylactic treatments for this infection are not known. Recent studies have suggested that&#xD;
      Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main&#xD;
      objective of this study is to assess in patients with autoimmune disease treated with long&#xD;
      course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent&#xD;
      protective effect on the risk or the severity of infection with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pre- or post-exposure treatment strategy has been validated in some infectious diseases. In&#xD;
      particular, in HIV infection, this type of prophylactic treatment reduces the rate of&#xD;
      infection in at-risk populations. The first studies from Chinese show that in case of&#xD;
      immunosuppression or immunosuppressive treatment, whatever the causal pathology, COVID-19&#xD;
      infection is more severe. The present study presents a population of patients with lupus&#xD;
      (SLE) or Gougerot's disease (SGD) who are treated for a long time, with Hydroxy-Chloroquine.&#xD;
      The protective effect against COVID-19 infection of Hydroxy-Chloroquine compared to&#xD;
      populations not exposed to this drug requires to be assessed in patients and their control&#xD;
      groups under or without immunosuppressive treatments.&#xD;
&#xD;
      It is hypothesized that long-term treatment with Hydroxy-Chloroquine in SLE or SGD taken in&#xD;
      its usual indication before the onset of the pandemic could decrease the number of COVID19&#xD;
      infections and/or the intensity of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients with positive anti-COVID19 serology</measure>
    <time_frame>Day 1</time_frame>
    <description>Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with symptomatic or severe (hospitalization) form of infection</measure>
    <time_frame>Day 1</time_frame>
    <description>Rate of patients with symptomatic or severe (hospitalization) form of infection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Patient treated with Hydroxy-chloroquine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient without treatment with Hydroxy-chloroquine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID 19 serology</intervention_name>
    <description>Diagnosis of Covid-19 past infection will be made by serology</description>
    <arm_group_label>Patient treated with Hydroxy-chloroquine</arm_group_label>
    <arm_group_label>Patient without treatment with Hydroxy-chloroquine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID 19 Self-Questionnaire</intervention_name>
    <description>COVID 19 Self-Questionnaire</description>
    <arm_group_label>Patient treated with Hydroxy-chloroquine</arm_group_label>
    <arm_group_label>Patient without treatment with Hydroxy-chloroquine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group with hydroxychloroquine treatment (HC +):&#xD;
&#xD;
          -  LED/SG diagnosed&#xD;
&#xD;
          -  Treatment with Hydroxy-Chloroquine in the 3 months before and during the outbreak at&#xD;
             COVID 19, at least in December 2019. Patients may have treatment with&#xD;
             immunosuppressants in combination with Hydroxy-Chloroquine.&#xD;
&#xD;
          -  COVID19 diagnostic questionnaire and available serology result.&#xD;
&#xD;
        Group without hydroxychloroquine treatment (HC-) :&#xD;
&#xD;
          -  No Hydroxy-Chloroquine intake for more than 12 months&#xD;
&#xD;
             --&gt; HC- without an immunosuppressant&#xD;
&#xD;
          -  Viral hepatitis C cured for more than 12 months or primitive bile cholangitis (CBP)&#xD;
             whose diagnosis is based on international criteria.&#xD;
&#xD;
          -  Non-significant liver fibrosis assessed either by historical histology or by fibroscan&#xD;
             with non-significant liver fibrosis Metavir - F3 (at last available examination)&#xD;
&#xD;
          -  No Hydroxy-Chloroquine, or immunosuppressants have been taken for more than 12 months.&#xD;
&#xD;
          -  COVID19 diagnostic questionnaire and COVID19 serology result available.&#xD;
&#xD;
             --&gt;HC- with an immunosuppressant&#xD;
&#xD;
          -  Diagnosis of LED/SG according to the CAB criteria revised in 1997 or autoimmune&#xD;
             hepatitis according to the international criteria validated in 2008.&#xD;
&#xD;
          -  Patients treated with immunosuppressants for at least three months before the start of&#xD;
             the pandemic at COVID 19, at least since December 2019.&#xD;
&#xD;
          -  COVID19 diagnostic questionnaire and available serology result.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anti-CD20 or Cyclophosphamide taken during the six months prior to the completion of&#xD;
             the COVID 19 serology.&#xD;
&#xD;
          -  Refusal of a blood test for antibodies to COVID-19.&#xD;
&#xD;
          -  Protected adults&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Lack of health insurance coverage&#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>Laurent ALRIC, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurent ALRIC, Pr</last_name>
    <phone>05 61 32 29 09</phone>
    <phone_ext>+33</phone_ext>
    <email>alric.l@chu-toulouse.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gregory PUGNET, Pr</last_name>
    <phone>(0)5 61 77 71 26</phone>
    <phone_ext>+33</phone_ext>
    <email>pugnet.g@chu-toulouse.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Limoges university Hospital</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne-Laure FAUCHAIS, Pr</last_name>
      <phone>(0)5 55 05 80 61</phone>
      <phone_ext>+33</phone_ext>
      <email>mailto:anne-laure.fauchais@unilim.fr</email>
    </contact>
    <investigator>
      <last_name>Anne-Laure FAUCHAIS, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kim LY, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>31295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Georges-Philippe PAGEAUX, Pr</last_name>
      <phone>(0)4 67 33 73 81</phone>
      <phone_ext>+33</phone_ext>
      <email>mailto:gp-pageaux@chu-montpellier.fr</email>
    </contact>
    <investigator>
      <last_name>Georges-Philippe PAGEAUX, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphanie FAURE, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pitié Salpêtrière Hospital - Hépatologie</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pascal LEBRAY, Dr</last_name>
      <phone>01 42 53 05 96</phone>
      <phone_ext>+33</phone_ext>
      <email>Pascal.lebray@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Pascal LEBRAY, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edouard LARREY, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pitié Salpêtrière Hospital - Médecine interne</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Patrice CACOUB, Pr</last_name>
      <phone>01 42 17 80 27.</phone>
      <phone_ext>+33</phone_ext>
      <email>patrice.cacoub@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Patrice CACOUB, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mathieu VAUTIER, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Haut-Lévêque Hospital - Gastro-entérologie</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Victor DE LEDINGHEN, Pr</last_name>
      <phone>(0)5 57 65 64 39</phone>
      <phone_ext>+33</phone_ext>
      <email>mailto:victor.deledinghen@chu-bordeaux.fr</email>
    </contact>
    <investigator>
      <last_name>Victor DE LEDINGHEN, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie IRLES-DEPE, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Haut-Lévêque Hospital - Médecine interne</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-François VIALLARD, Pr</last_name>
      <phone>(0)5 57 65 64 83</phone>
      <phone_ext>+33</phone_ext>
      <email>mailto:jean-francois.viallard@chu-bordeaux.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-François VIALLARD, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Estibaliz LAZARO, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Joseph Ducuing Hospital - Médecine interne</name>
      <address>
        <city>Toulouse</city>
        <zip>31027</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin MICHAUD, Pr</last_name>
      <phone>(0)5 61 77 34 48</phone>
      <phone_ext>+33</phone_ext>
      <email>mailto:mmichaud@hjd.asso.fr</email>
    </contact>
    <investigator>
      <last_name>Martin MICHAUD, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francis GACHES, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toulouse university Hospital - Larrey Dermatologie</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carle PAUL, Pr</last_name>
      <phone>(0)5 67 77 81 20</phone>
      <phone_ext>+33</phone_ext>
      <email>paul.c@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Carle PAUL, PR</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christina LIVIDEANU, DR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toulouse University Hospital - Rhumatologie</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud CONSTANTIN, Pr</last_name>
      <phone>056177696</phone>
      <phone_ext>+33</phone_ext>
      <email>mailto:constantin.a@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Arnaud CONSTANTIN, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adeline RUYSSEN-WITRAND, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toulouse University Hospital</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique CHAUVEAU, Pr</last_name>
      <phone>(0)5 61 32 32 83</phone>
      <phone_ext>+33</phone_ext>
      <email>mailto:chauveau.d@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Dominique CHAUVEAU, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David RIBES, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Toulouse - Rangueil Médecine interne</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent ALRIC, Pr</last_name>
      <phone>05 61 32 35 95</phone>
      <phone_ext>+33</phone_ext>
      <email>alric.l@chu-toulouse.fr</email>
    </contact>
    <contact_backup>
      <last_name>Gregory PUGNET, Pr</last_name>
      <phone>05 61 77 71 26</phone>
      <phone_ext>+33</phone_ext>
      <email>pugnet.g@chu-toulouse.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Laurent ALRIC, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gregory PUGNET, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University hospital Toulouse - Purpan Médecine interne</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent SAILLER, Pr</last_name>
      <phone>0561772278</phone>
      <phone_ext>+33</phone_ext>
      <email>sailler.l@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Laurent SAILLER, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guillaume MOULIS, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.</citation>
    <PMID>32194981</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.</citation>
    <PMID>31995857</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lupus erythematous disease</keyword>
  <keyword>prophylaxis</keyword>
  <keyword>pre-emptive therapy</keyword>
  <keyword>Hydroxy-Chloroquine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04481633
org study id: RC31/20/0186
secondary id: 2020-A01906-33
nct id: NCT04481633
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or
      prophylactic treatments for this infection are not known. Recent studies have suggested that
      Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main
      objective of this study is to assess in patients with autoimmune disease treated with long
      course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent
      protective effect on the risk or the severity of infection with COVID-19.
A pre- or post-exposure treatment strategy has been validated in some infectious diseases. In
      particular, in HIV infection, this type of prophylactic treatment reduces the rate of
      infection in at-risk populations. The first studies from Chinese show that in case of
      immunosuppression or immunosuppressive treatment, whatever the causal pathology, COVID-19
      infection is more severe. The present study presents a population of patients with lupus
      (SLE) or Gougerot's disease (SGD) who are treated for a long time, with Hydroxy-Chloroquine.
      The protective effect against COVID-19 infection of Hydroxy-Chloroquine compared to
      populations not exposed to this drug requires to be assessed in patients and their control
      groups under or without immunosuppressive treatments.

      It is hypothesized that long-term treatment with Hydroxy-Chloroquine in SLE or SGD taken in
      its usual indication before the onset of the pandemic could decrease the number of COVID19
      infections and/or the intensity of the disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rate of patients with positive anti-COVID19 serology
time frame: Day 1
description: Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.
measure: Rate of patients with symptomatic or severe (hospitalization) form of infection
time frame: Day 1
description: Rate of patients with symptomatic or severe (hospitalization) form of infection.
arm group label: Patient treated with Hydroxy-chloroquine
arm group type: Other
description: patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
arm group label: Patient without treatment with Hydroxy-chloroquine
arm group type: Other
description: patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants
intervention type: Diagnostic Test
intervention name: COVID 19 serology
description: Diagnosis of Covid-19 past infection will be made by serology
arm group label: Patient treated with Hydroxy-chloroquine
arm group label: Patient without treatment with Hydroxy-chloroquine
intervention type: Other
intervention name: COVID 19 Self-Questionnaire
description: COVID 19 Self-Questionnaire
arm group label: Patient treated with Hydroxy-chloroquine
arm group label: Patient without treatment with Hydroxy-chloroquine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent ALRIC, Pr
role: Principal Investigator
affiliation: University Hospital, Toulouse
last name: Laurent ALRIC, Pr
phone: 05 61 32 29 09
phone ext: +33
email: alric.l@chu-toulouse.fr
last name: Gregory PUGNET, Pr
phone: (0)5 61 77 71 26
phone ext: +33
email: pugnet.g@chu-toulouse.fr
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status: Not yet recruiting
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country: France
citation: Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.
PMID: 32194981
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: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PMID: 31995857
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No