xml: <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/NCT06016556</url>
    </required_header>
    <id_info>
      <org_study_id>C4671054</org_study_id>
      <nct_id>NCT06016556</nct_id>
    </id_info>
    <brief_title>A Study to Assess Patient Characteristics and Healthcare Resource Use (HCRU) Among COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia</brief_title>
    <official_title>Title Not in Corporate Clinical Trial Registry (CCTR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</source>
    <brief_summary>
      <textblock>
        The aim of this study is to describe the baseline demographic, clinical characteristics, and&#xD;
        Healthcare Resource Use (HCRU) of adult (≥18 years) COVID-19 patients who have been&#xD;
        prescribed nirmatrelvir, ritonavir treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Age</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Gender</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Ethnicity</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Education</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Employment status</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Height</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Weight</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Body Mass Index (BMI)</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Smoking status</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Pre-existing Comorbidities</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Concomitant medications for comorbidities at index date</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Medications used to treat COVID-19</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Previous COVID-19 infection during the last 6 months</measure>
      <time_frame>Baseline</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of Participants HRU: Inpatient setting</measure>
      <time_frame>Within the 30-day period following nirmatrelvir, ritonavir prescription</time_frame>
      <description>Days hospitalized, days in Intensive care unit (ICU) admission and length of stay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of Participants HRU</measure>
      <time_frame>Within the 30-day period following nirmatrelvir, ritonavir prescription</time_frame>
      <description>Yes/no questionnaire on outpatient visits, ER visits, supplemental oxygen use, vasopressor use, patient intubation.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Covid-19</condition>
    <arm_group>
      <arm_group_label>Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)</arm_group_label>
      <description>Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>nirmatrelvir, ritonavir</intervention_name>
      <description>single cohort</description>
      <arm_group_label>Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)</arm_group_label>
      <other_name>Paxlovid</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will involve collection of pre-defined, structured data retrospectively from&#xD;
          medical records (electronic and/or paper if necessary) of patients who meet the study&#xD;
          eligibility criteria and who have been prescribed nirmatrelvir, ritonavir treatment within&#xD;
          a 15-month lookback period from the date of site initiation (Cohort 1). The lookback period&#xD;
          will span from 01 April 2022 to 30 June 2023. Data abstracted from patients' medical&#xD;
          records will include patient demographics and clinical characteristics at index date&#xD;
          (defined as the date of nirmatrelvir, ritonavir treatment prescribing), in addition to&#xD;
          patients' HCRU during the 30-day period post-index date.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed COVID-19 infection during the study observation period&#xD;
  &#xD;
            -  Nirmatrelvir, ritonavir written prescription&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Saudi Arabia</name>
        <address>
          <city>Riyadh</city>
          <country>Saudi Arabia</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashraf Assanien, MD</last_name>
        <email>ashraf.m.assanien@pfizer.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Paxlovid</keyword>
    <keyword>Saudi Arabia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ritonavir</mesh_term>
      <mesh_term>Nirmatrelvir</mesh_term>
      <mesh_term>Nirmatrelvir and ritonavir drug combination</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016556
  org study id: C4671054
  nct id: NCT06016556
  lead sponsor: 
  The aim of this study is to describe the baseline demographic, clinical characteristics, and
        Healthcare Resource Use (HCRU) of adult (≥18 years) COVID-19 patients who have been
        prescribed nirmatrelvir, ritonavir treatment.
  observational model: Cohort
  time perspective: Retrospective
  measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Age
  time frame: Baseline
  measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Gender
  time frame: Baseline
  measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Ethnicity
  time frame: Baseline
  measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Education
  time frame: Baseline
  measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Employment status
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Height
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Weight
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Body Mass Index (BMI)
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Smoking status
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Pre-existing Comorbidities
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Concomitant medications for comorbidities at index date
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Medications used to treat COVID-19
  time frame: Baseline
  measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Previous COVID-19 infection during the last 6 months
  time frame: Baseline
  measure: Assessment of Participants HRU: Inpatient setting
  time frame: Within the 30-day period following nirmatrelvir, ritonavir prescription
  description: Days hospitalized, days in Intensive care unit (ICU) admission and length of stay.
  measure: Assessment of Participants HRU
  time frame: Within the 30-day period following nirmatrelvir, ritonavir prescription
  description: Yes/no questionnaire on outpatient visits, ER visits, supplemental oxygen use, vasopressor use, patient intubation.
  arm group label: Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
  description: Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription.
  intervention type: Drug
  intervention name: nirmatrelvir, ritonavir
  description: single cohort
  arm group label: Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
  other name: Paxlovid
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  facility: 
  contact: 
  country: Saudi Arabia
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Ritonavir
  mesh term: Nirmatrelvir
  mesh term: Nirmatrelvir and ritonavir drug combination
  sharing ipd: No
  ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.