<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/NCT04435314</url>
  </required_header>
  <id_info>
    <org_study_id>NITFQM0620OR</org_study_id>
    <nct_id>NCT04435314</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19</brief_title>
  <official_title>Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azidus Brasil</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Farmoquimica S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Azidus Brasil</source>
  <oversight_info>
    <has_dmc>No</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 primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600&#xD;
      mg, administered three times a day, in relation to placebo in preventing the development of&#xD;
      COVID-19 in subjects from vulnerable communities that had direct contact with patients&#xD;
      diagnosed with the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600&#xD;
      mg, administered three times a day, in relation to placebo in preventing the development of&#xD;
      COVID-19 in subjects from vulnerable communities that had direct contact with patients&#xD;
      diagnosed with the disease.&#xD;
&#xD;
      Subjects that PCR is negative after having direct contact with symptomatic subjects and&#xD;
      diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or&#xD;
      placebo TID for 7 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor's strategic decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study</measure>
    <time_frame>28 days</time_frame>
    <description>PCR will be done to evaluate infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>28 days</time_frame>
    <description>Number of participants with treatment-related adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study</measure>
    <time_frame>28 days</time_frame>
    <description>Symptomatic PCR positive subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study</measure>
    <time_frame>28 days</time_frame>
    <description>Asymptomatic PCR will be done to evaluate infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment adherence</measure>
    <time_frame>7 days</time_frame>
    <description>Subject adherence to treatment will be assessed through study diary record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease complication</measure>
    <time_frame>28 days</time_frame>
    <description>Proportion of patients with severe condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of subjects that underwent unscheduled visit</measure>
    <time_frame>28 days</time_frame>
    <description>Proportion of patient that needed undergo an unscheduled visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>covid19</condition>
  <arm_group>
    <arm_group_label>nitazoxanide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive nitazonanide 600 mg TID.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive placebo TID.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitazoxanide</intervention_name>
    <description>Subjects will receive nitazonanide 600 mg TID for 7 days</description>
    <arm_group_label>nitazoxanide</arm_group_label>
    <other_name>Viranitta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive placebo TID for 7 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent from patient or legal representative.&#xD;
&#xD;
          -  Subject of both genders (male and female not pregnant and not breastfeeding) aged 18&#xD;
             years or over;&#xD;
&#xD;
          -  Subject that lives in a vulnerable community;&#xD;
&#xD;
          -  Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as&#xD;
             they live or work directly with index patients;&#xD;
&#xD;
          -  Not showing symptoms compatible with COVID-19 and and that do not have a positive&#xD;
             RT-PCR test in a nasopharyngeal swab sample before randomization;&#xD;
&#xD;
          -  Participant capable of understanding and fulfilling all activities planned for the&#xD;
             study;&#xD;
&#xD;
          -  In use of an acceptable method of contraception throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in another RCT in the past 12 months;&#xD;
&#xD;
          -  Positive PCR result for COVID-19 during screening;&#xD;
&#xD;
          -  History of infection confirmed by SARS-CoV-2;&#xD;
&#xD;
          -  Present symptoms suggestive of SARS-CoV-2 infection;&#xD;
&#xD;
          -  Presence of comorbidities, which have a contraindication to the use of the study&#xD;
             product, not being restricted to:&#xD;
&#xD;
               -  HIV or HTLV virus infection;&#xD;
&#xD;
               -  Chronic hepatitis C (HCV) treated with direct antiviral drugs;&#xD;
&#xD;
               -  Liver failure;&#xD;
&#xD;
               -  Severe renal failure, including dialysis;&#xD;
&#xD;
          -  Present hypersensitivity to the study product (nitazoxanide), as well as to related&#xD;
             compounds;&#xD;
&#xD;
          -  Concomitant administration of drugs that may interact with the product under study&#xD;
             (nitazoxanide);&#xD;
&#xD;
          -  Participants who underwent treatment with antivirals and / or antiparasitic drugs in&#xD;
             the last 30 days;&#xD;
&#xD;
          -  Subject in antineoplastic treatment with chemotherapy or radiation therapy;&#xD;
&#xD;
          -  Subject with severe autoimmune diseases in immunosuppression;&#xD;
&#xD;
          -  Transplanted participants;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Any other clinical condition that is deemed by the Investigator to be an imminent risk&#xD;
             to the health and life of the subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reginaldo Raimundo Fujita</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 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>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitazoxanide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.</ipd_description>
  </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/NCT04435314
org study id: NITFQM0620OR
nct id: NCT04435314
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600
      mg, administered three times a day, in relation to placebo in preventing the development of
      COVID-19 in subjects from vulnerable communities that had direct contact with patients
      diagnosed with the disease.
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600
      mg, administered three times a day, in relation to placebo in preventing the development of
      COVID-19 in subjects from vulnerable communities that had direct contact with patients
      diagnosed with the disease.

      Subjects that PCR is negative after having direct contact with symptomatic subjects and
      diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or
      placebo TID for 7 days.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
time frame: 28 days
description: PCR will be done to evaluate infection
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 28 days
description: Number of participants with treatment-related adverse events
measure: The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
time frame: 28 days
description: Symptomatic PCR positive subjects
measure: The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study
time frame: 28 days
description: Asymptomatic PCR will be done to evaluate infection
measure: Treatment adherence
time frame: 7 days
description: Subject adherence to treatment will be assessed through study diary record
measure: Disease complication
time frame: 28 days
description: Proportion of patients with severe condition
measure: Incidence of subjects that underwent unscheduled visit
time frame: 28 days
description: Proportion of patient that needed undergo an unscheduled visit
arm group label: nitazoxanide
arm group type: Experimental
description: Subjects will receive nitazonanide 600 mg TID.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive placebo TID.
intervention type: Drug
intervention name: Nitazoxanide
description: Subjects will receive nitazonanide 600 mg TID for 7 days
arm group label: nitazoxanide
other name: Viranitta
intervention type: Drug
intervention name: Placebo
description: Subjects will receive placebo TID for 7 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Reginaldo Raimundo Fujita
role: Principal Investigator
affiliation: Federal University of São Paulo
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Nitazoxanide
sharing ipd: No
ipd description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.