<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/NCT04471649</url>
  </required_header>
  <id_info>
    <org_study_id>002</org_study_id>
    <nct_id>NCT04471649</nct_id>
  </id_info>
  <brief_title>Hydroxy Chloroquine and Covid in RA Patients</brief_title>
  <acronym>Covid-19</acronym>
  <official_title>Clinical Course of COVID-19 in Patients With Rheumatoid Arthritis Treated With or Without Hydroxychloroquine: a Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <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 clinical course of COVID-19 in a cohort of patients with rheumatoid&#xD;
      arthritis treated with or without hydroxychloroquine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study settings &amp; sample:&#xD;
&#xD;
      This is an observational, retrospective -case-control, single-center study. This study will&#xD;
      include patients who meet the inclusion criteria followed in the Department of Rheumatology&#xD;
      and Rehabilitation, Tanta University Hospital, Tanta, Egypt.&#xD;
&#xD;
      Data will be taken from the medical records of patients with rheumatoid arthritis in the&#xD;
      outpatient clinic of the Rheumatology and Rehabilitation Department, Tanta University&#xD;
      Hospital, Tanta, Egypt. All patients will sign the informed consent form authorizing the&#xD;
      collection of these data.&#xD;
&#xD;
      Group classification A) Patients with rheumatoid arthritis using hydroxychloroquine as a part&#xD;
      of their treatment regimen.&#xD;
&#xD;
      b) Patients with rheumatoid arthritis not using hydroxychloroquine as a part of their&#xD;
      treatment regimen.&#xD;
&#xD;
      Data will be collected and analyzed from patient medical records. It will include the&#xD;
      following:&#xD;
&#xD;
        1. Epidemiologic, demographic, and clinical data.&#xD;
&#xD;
        2. Severity of rheumatoid arthritis.&#xD;
&#xD;
        3. Rheumatoid arthritis activity state using the Clinical Disease Activity Index&#xD;
&#xD;
        4. Dose and duration of hydroxychloroquine&#xD;
&#xD;
        5. Need for hospitalization, length of hospital stay, and ICU admission including the need&#xD;
           for mechanical ventilation.&#xD;
&#xD;
        6. Duration from the start of symptoms until clinical cure.&#xD;
&#xD;
        7. Severity of COVID-19 disease according to the World Health Organization interim guidance&#xD;
&#xD;
        8. Prognosis.&#xD;
&#xD;
      Laboratory investigations and imaging:&#xD;
&#xD;
        1. Complete blood count.&#xD;
&#xD;
        2. Renal and liver function tests.&#xD;
&#xD;
        3. Random blood sugar.&#xD;
&#xD;
        4. Lactate dehydrogenase, D-dimer.&#xD;
&#xD;
        5. Serum ferritin, C-reactive protein,&#xD;
&#xD;
        6. Chest radiographs or CT scan&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients in need for hospitalization</measure>
    <time_frame>through study completion an average 12 weeks</time_frame>
    <description>Estimate number of patients in need for hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospitalization and ICU admission</measure>
    <time_frame>through study completion an average 12 weeks</time_frame>
    <description>Calculate the number of days that the patients stayed at the hospital and how many patients admitted to ICU</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The need for mechanical ventilation</measure>
    <time_frame>through study completion an average 12 weeks</time_frame>
    <description>Calculate the number of patients who received mechanical ventilation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of COVID-19 disease</measure>
    <time_frame>through study completion an average 12 weeks</time_frame>
    <description>WHO clinical management Covid19 interim guidance disease severity Algorithm</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <description>Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator</arm_group_label>
    <description>Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        To Evaluaye the clinical course of COVID-19 in a cohort of patients with rheumatoid&#xD;
        arthritis treated with or without hydroxychloroquine:&#xD;
&#xD;
        Data will be taken from the medical records of patients with rheumatoid arthritis in the&#xD;
        outpatient clinic of the Rheumatology and Rehabilitation department, Tanta University&#xD;
        hospital, Tanta, Egypt.&#xD;
&#xD;
        A) Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment&#xD;
        regimen.&#xD;
&#xD;
        b) Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their&#xD;
        treatment regimen.&#xD;
&#xD;
        Primary Outcome Measures:&#xD;
&#xD;
        1. Impact of hydroxychloroquine on the clinical course of Covid-19 in the&#xD;
        hydroxychloroquine group compared to the non- hydroxychloroquine group.&#xD;
&#xD;
        Data will be collected and analyzed from patient medical records.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with rheumatoid arthritis superinfected with Covid-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient data are available in the medical record.&#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>Asem Elfert, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>tanta university faculty of medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammed Hassan Abu-Zaid, PhD</last_name>
    <phone>+201006773622</phone>
    <email>Drmhassan113@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Samar Tabra, PhD</last_name>
    <phone>+201007501572</phone>
    <email>Dr_stabra_113@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tanta University Hospital</name>
      <address>
        <city>Tanta</city>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammed Hassan Abu-Zaid, PhD</last_name>
      <phone>+201006773622</phone>
      <email>drmhassan113@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Samar A Tabra, PhD</last_name>
      <phone>+201007501572</phone>
      <email>dr_stabra_113@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.</citation>
    <PMID>32173110</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Mohammed Hassan Abu-Zaid</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>Hydroxy chloroquine</keyword>
  <keyword>Rheumatoid</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04471649
org study id: 002
nct id: NCT04471649
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
evaluation of the clinical course of COVID-19 in a cohort of patients with rheumatoid
      arthritis treated with or without hydroxychloroquine.
Study settings & sample:

      This is an observational, retrospective -case-control, single-center study. This study will
      include patients who meet the inclusion criteria followed in the Department of Rheumatology
      and Rehabilitation, Tanta University Hospital, Tanta, Egypt.

      Data will be taken from the medical records of patients with rheumatoid arthritis in the
      outpatient clinic of the Rheumatology and Rehabilitation Department, Tanta University
      Hospital, Tanta, Egypt. All patients will sign the informed consent form authorizing the
      collection of these data.

      Group classification A) Patients with rheumatoid arthritis using hydroxychloroquine as a part
      of their treatment regimen.

      b) Patients with rheumatoid arthritis not using hydroxychloroquine as a part of their
      treatment regimen.

      Data will be collected and analyzed from patient medical records. It will include the
      following:

        1. Epidemiologic, demographic, and clinical data.

        2. Severity of rheumatoid arthritis.

        3. Rheumatoid arthritis activity state using the Clinical Disease Activity Index

        4. Dose and duration of hydroxychloroquine

        5. Need for hospitalization, length of hospital stay, and ICU admission including the need
           for mechanical ventilation.

        6. Duration from the start of symptoms until clinical cure.

        7. Severity of COVID-19 disease according to the World Health Organization interim guidance

        8. Prognosis.

      Laboratory investigations and imaging:

        1. Complete blood count.

        2. Renal and liver function tests.

        3. Random blood sugar.

        4. Lactate dehydrogenase, D-dimer.

        5. Serum ferritin, C-reactive protein,

        6. Chest radiographs or CT scan
observational model: Case-Control
time perspective: Retrospective
measure: Number of patients in need for hospitalization
time frame: through study completion an average 12 weeks
description: Estimate number of patients in need for hospitalization
measure: Length of hospitalization and ICU admission
time frame: through study completion an average 12 weeks
description: Calculate the number of days that the patients stayed at the hospital and how many patients admitted to ICU
measure: The need for mechanical ventilation
time frame: through study completion an average 12 weeks
description: Calculate the number of patients who received mechanical ventilation
measure: Severity of COVID-19 disease
time frame: through study completion an average 12 weeks
description: WHO clinical management Covid19 interim guidance disease severity Algorithm
arm group label: Experimental
description: Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
arm group label: Active Comparator
description: Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Asem Elfert, Prof
role: Study Chair
affiliation: tanta university faculty of medicine
last name: Mohammed Hassan Abu-Zaid, PhD
phone: +201006773622
email: Drmhassan113@yahoo.com
last name: Samar Tabra, PhD
phone: +201007501572
email: Dr_stabra_113@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
citation: Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.
PMID: 32173110
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Mohammed Hassan Abu-Zaid
investigator title: Principal Investigator
sharing ipd: Undecided