<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/NCT04425382</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-05-069</org_study_id>
    <nct_id>NCT04425382</nct_id>
  </id_info>
  <brief_title>Darunavir/Cobicistat vs. Lopinavir/Ritonavir in COVID-19 Pneumonia in Qatar</brief_title>
  <acronym>DOLCI</acronym>
  <official_title>Efficacy and Safety of Darunavir/Cobicistat vs. Lopinavir/Ritonavir in the Management of Patients With COVID-19 Pneumonia in Qatar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamad Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamad Medical Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronavirus Disease 2019 (COVID-19) is a disease caused by the Severe Acute Respiratory&#xD;
      Syndrome Coronavirus 2 (SARS-CoV-2) virus. It was first isolated in Wuhan, China in December&#xD;
      2019 and then rapidly spread to the rest of the world posing a severe threat to global&#xD;
      health.&#xD;
&#xD;
      Many therapeutics have been investigated for the treatment of this disease with inconclusive&#xD;
      outcomes. Protease inhibitors are one of the proposed agents, but their use is limited to&#xD;
      their significant drug interactions and side effects.&#xD;
&#xD;
      The aim of this study is to compare the efficacy and safety outcomes of Darunavir/Cobicistat&#xD;
      versus Lopinavir /Ritonavir in the treatment of patients with COVID-19 pneumonia in Qatar.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint)</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Clinical Improvement is defined as the time to normalization of fever (defined as temperature &lt;37.8 oC for 72 hours) and/or resolution of baseline sign/symptoms, without the need for symptomatic treatment&#xD;
Virological clearance is defined as the time to two consecutive negative COVID-19 PCR samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Virological Clearance</measure>
    <time_frame>At day 14, day 21, and day 28.</time_frame>
    <description>o Defined as two consecutive negative COVID-19 PCR samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Clinical Deterioration</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>At 30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Coronavirus</condition>
  <condition>COVID</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Darunavir/Cobicistat</arm_group_label>
    <description>Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lopinavir/Ritonavir</arm_group_label>
    <description>Patient received Lopinavir/Ritonavir (Kaletra®) as part of the treatment regimen for COVID-19 pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darunavir/Cobicistat</intervention_name>
    <description>Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily</description>
    <arm_group_label>Darunavir/Cobicistat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lopinavir/Ritonavir</intervention_name>
    <description>Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily</description>
    <arm_group_label>Lopinavir/Ritonavir</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patient who were admitted to HMC hospitals with laboratory confirmed 2019-nCoV&#xD;
        infection who meet the inclusion criteria during the review period will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients ≥18 years of age&#xD;
&#xD;
          -  Laboratory confirmed 2019-nCoV infection as determined by the PCR of the&#xD;
             nasopharyngeal/oropharyngeal swab.&#xD;
&#xD;
          -  Radiologically confirmed pneumonia (Based on the chest x-ray or CT scan imaging).&#xD;
&#xD;
          -  Have received either Darunavir/Cobicistat or Lopinavir/Ritonavir as part of the&#xD;
             treatment regimen for COVID-19 pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria will be applied&#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>Dr. Eman Elmekaty, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamad Medical Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamad Medical Corporation</name>
      <address>
        <city>Doha</city>
        <country>Qatar</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Qatar</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Lopinavir</mesh_term>
    <mesh_term>Darunavir</mesh_term>
    <mesh_term>Cobicistat</mesh_term>
    <mesh_term>Cobicistat mixture with darunavir</mesh_term>
  </intervention_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/NCT04425382
org study id: MRC-05-069
nct id: NCT04425382
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Coronavirus Disease 2019 (COVID-19) is a disease caused by the Severe Acute Respiratory
      Syndrome Coronavirus 2 (SARS-CoV-2) virus. It was first isolated in Wuhan, China in December
      2019 and then rapidly spread to the rest of the world posing a severe threat to global
      health.

      Many therapeutics have been investigated for the treatment of this disease with inconclusive
      outcomes. Protease inhibitors are one of the proposed agents, but their use is limited to
      their significant drug interactions and side effects.

      The aim of this study is to compare the efficacy and safety outcomes of Darunavir/Cobicistat
      versus Lopinavir /Ritonavir in the treatment of patients with COVID-19 pneumonia in Qatar.
observational model: Other
time perspective: Retrospective
measure: Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint)
time frame: Up to 90 days
description: Clinical Improvement is defined as the time to normalization of fever (defined as temperature <37.8 oC for 72 hours) and/or resolution of baseline sign/symptoms, without the need for symptomatic treatment
Virological clearance is defined as the time to two consecutive negative COVID-19 PCR samples
measure: Percentage of Virological Clearance
time frame: At day 14, day 21, and day 28.
description: o Defined as two consecutive negative COVID-19 PCR samples
measure: Percentage of Clinical Deterioration
time frame: Up to 28 days
description: o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy
measure: Incidence of Adverse Events
time frame: Up to 28 days
measure: Length of Hospital Stay
time frame: Up to 90 days
measure: All-cause Mortality
time frame: At 30 days
arm group label: Darunavir/Cobicistat
description: Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia
arm group label: Lopinavir/Ritonavir
description: Patient received Lopinavir/Ritonavir (Kaletra®) as part of the treatment regimen for COVID-19 pneumonia
intervention type: Drug
intervention name: Darunavir/Cobicistat
description: Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily
arm group label: Darunavir/Cobicistat
intervention type: Drug
intervention name: Lopinavir/Ritonavir
description: Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily
arm group label: Lopinavir/Ritonavir
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Eman Elmekaty, PharmD
role: Principal Investigator
affiliation: Hamad Medical Corporation
facility: 
country: Qatar
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Ritonavir
mesh term: Lopinavir
mesh term: Darunavir
mesh term: Cobicistat
mesh term: Cobicistat mixture with darunavir
sharing ipd: No