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/NCT05997485</url>
    </required_header>
    <id_info>
      <org_study_id>C4671060</org_study_id>
      <nct_id>NCT05997485</nct_id>
    </id_info>
    <brief_title>A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco</brief_title>
    <official_title>A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics Among COVID-19 Patients Receiving Treatment With Nirmatrelvir/Ritonavir (PAXLOVIDTM) in Morocco.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</source>
    <brief_summary>
      <textblock>
        The purpose of this study is to collect information on the:&#xD;
  &#xD;
          -  general information of a group of people such as their age, sex, and other facts.&#xD;
  &#xD;
          -  clinical information of the patients such as any other illness before having COVID 19.&#xD;
  &#xD;
        In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir&#xD;
        treatment.&#xD;
  &#xD;
        This study will be conducted in Morocco. The study will capture information of the adult&#xD;
        COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir&#xD;
        treatment. The inpatients will be admitted in the hospital for other reasons than COVID-19.&#xD;
  &#xD;
        This study will have about 150 patients. The study will involve collection of patient&#xD;
        information from medical records. The information collected can be either from papers or from&#xD;
        computers.&#xD;
  &#xD;
        The study will include patient information of those who:&#xD;
  &#xD;
          -  are confirmed to have COVID-19 infection during the study period from 01 June 2022 to 30&#xD;
             June 2023.&#xD;
  &#xD;
          -  are 18 years of age or older.&#xD;
  &#xD;
          -  are prescribed Nirmatrelvir and ritonavir. This study will help to inform&#xD;
             decision-making on use of Paxlovid at the national level.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>Demographical Characteristics of Participants</measure>
      <time_frame>Approximately 01 June 2022 through 30 June 2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Characteristics of Participants</measure>
      <time_frame>Approximately 01 June 2022 through 30 June 2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Pre-existing Comorbidites</measure>
      <time_frame>Approximately 01 June 2022 through 30 June 2023</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>COVID-19 Drug Treatment</condition>
    <arm_group>
      <arm_group_label>Participants receiving Paxlovid Treatment</arm_group_label>
      <description>Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nirmatrelvir/Ritonavir</intervention_name>
      <description>Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.</description>
      <arm_group_label>Participants receiving Paxlovid Treatment</arm_group_label>
      <other_name>Paxlovid</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants treated with Paxlovid in single center in Morocco.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed COVID-19 infection during the study period from 01 June 2022 to 30 June 2023&#xD;
  &#xD;
            -  Nirmatrelvir, ritonavir written prescription&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  There are no exclusion criteria for this study.&#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>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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Treatment</keyword>
    <keyword>Covid Patient</keyword>
    <keyword>Paxlovid</keyword>
    <keyword>Morocco</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/NCT05997485
  org study id: C4671060
  nct id: NCT05997485
  lead sponsor: 
  The purpose of this study is to collect information on the:
  
          -  general information of a group of people such as their age, sex, and other facts.
  
          -  clinical information of the patients such as any other illness before having COVID 19.
  
        In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir
        treatment.
  
        This study will be conducted in Morocco. The study will capture information of the adult
        COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir
        treatment. The inpatients will be admitted in the hospital for other reasons than COVID-19.
  
        This study will have about 150 patients. The study will involve collection of patient
        information from medical records. The information collected can be either from papers or from
        computers.
  
        The study will include patient information of those who:
  
          -  are confirmed to have COVID-19 infection during the study period from 01 June 2022 to 30
             June 2023.
  
          -  are 18 years of age or older.
  
          -  are prescribed Nirmatrelvir and ritonavir. This study will help to inform
             decision-making on use of Paxlovid at the national level.
  observational model: Cohort
  time perspective: Retrospective
  measure: Demographical Characteristics of Participants
  time frame: Approximately 01 June 2022 through 30 June 2023
  measure: Clinical Characteristics of Participants
  time frame: Approximately 01 June 2022 through 30 June 2023
  measure: Number of Participants with Pre-existing Comorbidites
  time frame: Approximately 01 June 2022 through 30 June 2023
  arm group label: Participants receiving Paxlovid Treatment
  description: Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.
  intervention type: Drug
  intervention name: Nirmatrelvir/Ritonavir
  description: Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.
  arm group label: Participants receiving Paxlovid Treatment
  other name: Paxlovid
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  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
  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.