<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/NCT04409483</url>
  </required_header>
  <id_info>
    <org_study_id>Trascov</org_study_id>
    <nct_id>NCT04409483</nct_id>
  </id_info>
  <brief_title>Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger</brief_title>
  <acronym>TRASCOV</acronym>
  <official_title>Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epicentre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université Abdou Moumouni</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre de Recherche Médicale et Sanitaire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Public Health, Republic of Niger</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Epicentre</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>
      The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other&#xD;
      antiviral drugs) is effective at reducing the rate of hospitalization among confirmed&#xD;
      COVID-19 cases treated as outpatients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and potential risks, all patients who meet all&#xD;
      eligibility criteria and who give written informed consent will be randomized to receive&#xD;
      standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14&#xD;
      days). Participants will receive daily visits from study staff for 15 days and be followed&#xD;
      for a total of 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Epidemic dynamics&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospitalization or death</measure>
    <time_frame>15 days following randomization</time_frame>
    <description>Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>15 days following randomization</time_frame>
    <description>Death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>28 days following randomization</time_frame>
    <description>Death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to hospitalization</measure>
    <time_frame>28 days following randomization</time_frame>
    <description>Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospitalization</measure>
    <time_frame>28 days following randomization</time_frame>
    <description>Total duration of hospitalization associated with desaturation (SpO2 ≤92%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to intensive care</measure>
    <time_frame>28 days following randomization</time_frame>
    <description>Proportion of participants admitted to an intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>28 days following randomization</time_frame>
    <description>Proportion of participants having an adverse event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>28 days following randomization</time_frame>
    <description>Proportion of participants having a serious adverse event</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care for COVID-19 according to the national guidelines of Niger</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care plus lopinavir/ritonavir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lopinavir-Ritonavir Drug Combination</intervention_name>
    <description>400mg/100mg taken orally twice daily for 14 days.</description>
    <arm_group_label>Standard Care plus lopinavir/ritonavir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily</description>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_label>Standard Care plus lopinavir/ritonavir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspect, probable or confirmed case of COVID-19&#xD;
&#xD;
          -  Men and women aged ≥12 years, including pregnant and breastfeeding women&#xD;
&#xD;
          -  SpO2 ≥93% on room air&#xD;
&#xD;
          -  Signature of informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical indication for hospitalization at the time of enrolment&#xD;
&#xD;
          -  Severe chronic liver disease&#xD;
&#xD;
          -  Known infection with HIV&#xD;
&#xD;
          -  Known allergy or severe intolerance to lopinavir/ritonavir&#xD;
&#xD;
          -  Absolute contra-indication to lopinavir/ritonavir, including concomitant therapy with&#xD;
             a medication whose metabolism is dependent on isoform CPY3A with a narrow therapeutic&#xD;
             window (e.g., amiodarone, colchicine, simvastatin, lovastatin, etc.)&#xD;
&#xD;
          -  Treatment with an antiviral medication in the 28 days prior to enrolment&#xD;
&#xD;
          -  Dementia or other condition that interferes with active participation in data&#xD;
             collection and obtaining informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca F Grais</last_name>
    <role>Study Director</role>
    <affiliation>Epicentre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Adehossi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Général de Référence de Niamey</affiliation>
  </overall_official>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</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>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>Lopinavir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified patient data will be shared with local and international authorities.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will become fully accessible after primary publication of results.</ipd_time_frame>
  </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/NCT04409483
org study id: Trascov
nct id: NCT04409483
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other
      antiviral drugs) is effective at reducing the rate of hospitalization among confirmed
      COVID-19 cases treated as outpatients.
After being informed about the study and potential risks, all patients who meet all
      eligibility criteria and who give written informed consent will be randomized to receive
      standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14
      days). Participants will receive daily visits from study staff for 15 days and be followed
      for a total of 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hospitalization or death
time frame: 15 days following randomization
description: Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause
measure: All-cause mortality
time frame: 15 days following randomization
description: Death due to any cause
measure: All-cause mortality
time frame: 28 days following randomization
description: Death due to any cause
measure: Time to hospitalization
time frame: 28 days following randomization
description: Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)
measure: Length of hospitalization
time frame: 28 days following randomization
description: Total duration of hospitalization associated with desaturation (SpO2 ≤92%)
measure: Admission to intensive care
time frame: 28 days following randomization
description: Proportion of participants admitted to an intensive care unit
measure: Adverse events
time frame: 28 days following randomization
description: Proportion of participants having an adverse event
measure: Serious adverse events
time frame: 28 days following randomization
description: Proportion of participants having a serious adverse event
arm group label: Standard Care
arm group type: Active Comparator
description: Standard care for COVID-19 according to the national guidelines of Niger
arm group label: Standard Care plus lopinavir/ritonavir
arm group type: Experimental
description: Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir
intervention type: Drug
intervention name: Lopinavir-Ritonavir Drug Combination
description: 400mg/100mg taken orally twice daily for 14 days.
arm group label: Standard Care plus lopinavir/ritonavir
intervention type: Combination Product
intervention name: Standard Care
description: Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily
arm group label: Standard Care
arm group label: Standard Care plus lopinavir/ritonavir
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca F Grais
role: Study Director
affiliation: Epicentre
last name: Eric Adehossi
role: Principal Investigator
affiliation: Hôpital Général de Référence de Niamey
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Ritonavir
mesh term: Lopinavir
sharing ipd: Yes
ipd description: De-identified patient data will be shared with local and international authorities.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will become fully accessible after primary publication of results.