<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/NCT04434118</url>
  </required_header>
  <id_info>
    <org_study_id>IRB: RC-5-2020</org_study_id>
    <nct_id>NCT04434118</nct_id>
  </id_info>
  <brief_title>Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients</brief_title>
  <official_title>Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sadat City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sadat City University</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>
      Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated&#xD;
      with immunosuppressive drugs, which may increase the risk of COVID-19 infection.&#xD;
      Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus,&#xD;
      the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among&#xD;
      RA patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Institutional Issue&#xD;
  </why_stopped>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</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>The risk of COVID-19 infection among RA patients</measure>
    <time_frame>12 week</time_frame>
    <description>Realtion between hydroxychloroquine use and COVID-19 infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of hospitalization for Covid-19 patients.</measure>
    <time_frame>12 week</time_frame>
    <description>Number of cases and number of hospitalization days</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis with COVID-19</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis without COVID-19</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Traditional antirheumatic drugs</intervention_name>
    <description>Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine</description>
    <arm_group_label>Rheumatoid Arthritis with COVID-19</arm_group_label>
    <arm_group_label>Rheumatoid Arthritis without COVID-19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients fulfilling 2010 ACR-EULAR classification criteria for RA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Data of all definite cases of RA were collected and reviewed from complete medical&#xD;
        records of patients by a team that included 2 trained physicians using a pretested data&#xD;
        collection form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria were included incomplete medical records or those with&#xD;
             difficulty to communicate with the patients.&#xD;
&#xD;
          -  Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute&#xD;
             coronary syndrome, acute pulmonary embolism, or acute stroke)&#xD;
&#xD;
          -  Patients with decompensated or end stage chronic organ dysfunction (e.g.,&#xD;
             decompensated cirrhosis, decompensated chronic renal insufficiency, or severe&#xD;
             congestive heart failure), diabetes mellitus, data of pregnant females, acquired&#xD;
             immune deficiency syndrome (aids), and leukemia or other malignancies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Shibīn Al Kawm</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sadat City University</investigator_affiliation>
    <investigator_full_name>Mahmoud Samy Abdallah</investigator_full_name>
    <investigator_title>Lecturer of Clinical Pharmacy, PhD.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antirheumatic Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT04434118
org study id: IRB: RC-5-2020
nct id: NCT04434118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated
      with immunosuppressive drugs, which may increase the risk of COVID-19 infection.
      Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus,
      the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among
      RA patients.
observational model: Case-Control
time perspective: Retrospective
measure: The risk of COVID-19 infection among RA patients
time frame: 12 week
description: Realtion between hydroxychloroquine use and COVID-19 infection
measure: The incidence of hospitalization for Covid-19 patients.
time frame: 12 week
description: Number of cases and number of hospitalization days
arm group label: Rheumatoid Arthritis with COVID-19
arm group label: Rheumatoid Arthritis without COVID-19
intervention type: Drug
intervention name: Traditional antirheumatic drugs
description: Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine
arm group label: Rheumatoid Arthritis with COVID-19
arm group label: Rheumatoid Arthritis without COVID-19
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sadat City University
investigator full name: Mahmoud Samy Abdallah
investigator title: Lecturer of Clinical Pharmacy, PhD.
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Antirheumatic Agents
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)