<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/NCT04497649</url>
  </required_header>
  <id_info>
    <org_study_id>Tanta sofosbuvir covid</org_study_id>
    <nct_id>NCT04497649</nct_id>
  </id_info>
  <brief_title>Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients</brief_title>
  <official_title>Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian&#xD;
      patients,&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian&#xD;
      patients,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">April 10, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with improvement or mortality</measure>
    <time_frame>1 month</time_frame>
    <description>The number of patients with improvement or mortality</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Sofosbuvir and Daklatasuvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sofosbuvir and Daklatasuvir with standard of care treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir</intervention_name>
    <description>Sofosbuvir once daily</description>
    <arm_group_label>Sofosbuvir and Daklatasuvir</arm_group_label>
    <other_name>Mpiviropack, Sovaldy, soflanork</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daclatasvir</intervention_name>
    <description>daclatasuvir once daily</description>
    <arm_group_label>Sofosbuvir and Daklatasuvir</arm_group_label>
    <other_name>daklinza, daklanork</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID 19 positive patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COVID-19 patients with critical manifestations.&#xD;
&#xD;
          -  Sepsis.&#xD;
&#xD;
          -  Acute respiratory distress syndrome (ARDS).&#xD;
&#xD;
          -  Decompensated liver disease (Child-Pugh class B or C disease).&#xD;
&#xD;
          -  Chronic renal impairment.&#xD;
&#xD;
          -  Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ….).&#xD;
&#xD;
          -  Ischemic heart disease within the last 6 months.&#xD;
&#xD;
          -  Chronic pulmonary disease.&#xD;
&#xD;
          -  Malignancy.&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  Hypersensitivity to sofosbuvir or ribavirin.&#xD;
&#xD;
          -  Patients with organ transplant.&#xD;
&#xD;
          -  Unwilling to participate in our study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marwa Salama, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta University - Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>sherief Abd-Elsalam, ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta University Faculty of medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Cordie, lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gamal Esmat, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherief Abd-Elsalam, ass. prof.</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>sherief abd-elsalan, ass. prof.</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cairo and Tanta Universitities</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sherief abd-elsalam, ass. prof</last_name>
      <phone>00201147773440</phone>
      <email>sheriefabdelsalam@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <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>Sofosbuvir</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/NCT04497649
org study id: Tanta sofosbuvir covid
nct id: NCT04497649
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian
      patients,
The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian
      patients,
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of patients with improvement or mortality
time frame: 1 month
description: The number of patients with improvement or mortality
arm group label: Sofosbuvir and Daklatasuvir
arm group type: Experimental
description: Sofosbuvir and Daklatasuvir with standard of care treatment
arm group label: Standard of care treatment
arm group type: No Intervention
description: Standard of care treatment
intervention type: Drug
intervention name: Sofosbuvir
description: Sofosbuvir once daily
arm group label: Sofosbuvir and Daklatasuvir
other name: Mpiviropack, Sovaldy, soflanork
intervention type: Drug
intervention name: Daclatasvir
description: daclatasuvir once daily
arm group label: Sofosbuvir and Daklatasuvir
other name: daklinza, daklanork
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marwa Salama, Lecturer
role: Principal Investigator
affiliation: Tanta University - Faculty of Medicine
last name: sherief Abd-Elsalam, ass. Prof.
role: Principal Investigator
affiliation: Tanta University Faculty of medicine
last name: Ahmed Cordie, lecturer
role: Principal Investigator
affiliation: Cairo University
last name: Gamal Esmat, Professor
role: Principal Investigator
affiliation: Cairo University
last name: Sherief Abd-Elsalam, ass. prof.
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
last name: sherief abd-elsalan, ass. prof.
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: COVID-19
mesh term: Sofosbuvir
sharing ipd: No