<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/NCT04441398</url>
  </required_header>
  <id_info>
    <org_study_id>NITFQM0720OR</org_study_id>
    <nct_id>NCT04441398</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients</brief_title>
  <official_title>Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita</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 aim is to demonstrate a decrease in complications among ambulatory patients who are&#xD;
      diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of&#xD;
      standard care compared to patients who receive standard care and placebo only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to demonstrate a decrease in complications among ambulatory patients who are&#xD;
      diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of&#xD;
      standard care compared to patients who receive standard care and placebo only.&#xD;
&#xD;
      After 7 days of treatment, the Investigator can extend the treatment duration for another 7&#xD;
      days at his/her discretion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor's strategic decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>
    <intervention_model_description>Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in signs and symptoms scale</measure>
    <time_frame>21 days</time_frame>
    <description>Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>21 days</time_frame>
    <description>Number of participants with treatment-related adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects hospitalized after start of treatment and before the end of the study</measure>
    <time_frame>21 days</time_frame>
    <description>Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study</measure>
    <time_frame>21 days</time_frame>
    <description>Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of symptoms</measure>
    <time_frame>21 days</time_frame>
    <description>Time required (days) to full symptom recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of mortality within 21-days</measure>
    <time_frame>21 days</time_frame>
    <description>Evaluation of change in acute respiratory syndrome</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. Treatment can be extended for another 7 days at Investigators discretion.</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. Treatment can be extended for another 7 days at Investigators discretion.</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 over&#xD;
             49;&#xD;
&#xD;
          -  Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase&#xD;
             chain reaction (RT-PCR) from any diagnostic sampling source;&#xD;
&#xD;
          -  Symptomatic subject with symptoms for up to 72 hours who does not require&#xD;
             hospitalization, with signs and symptoms of acute respiratory viral infection&#xD;
             characterized by a feverish sensation or fever, which may or may not be present at the&#xD;
             time of the examination (which may be reported to the health professional),&#xD;
             accompanied by cough or sore throat or runny nose or difficulty breathing and:&#xD;
&#xD;
             i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or&#xD;
             medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in another RCT in the past 12 months;&#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 other antiviral drugs;&#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>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edimilson Migowski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NEPS SEMUS Mesquita</affiliation>
  </overall_official>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 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/NCT04441398
org study id: NITFQM0720OR
nct id: NCT04441398
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to demonstrate a decrease in complications among ambulatory patients who are
      diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of
      standard care compared to patients who receive standard care and placebo only.
The aim is to demonstrate a decrease in complications among ambulatory patients who are
      diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of
      standard care compared to patients who receive standard care and placebo only.

      After 7 days of treatment, the Investigator can extend the treatment duration for another 7
      days at his/her discretion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in signs and symptoms scale
time frame: 21 days
description: Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 21 days
description: Number of participants with treatment-related adverse events
measure: The proportion of subjects hospitalized after start of treatment and before the end of the study
time frame: 21 days
description: Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
measure: The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study
time frame: 21 days
description: Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
measure: Duration of symptoms
time frame: 21 days
description: Time required (days) to full symptom recovery
measure: Rate of mortality within 21-days
time frame: 21 days
description: Evaluation of change in acute respiratory syndrome
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. Treatment can be extended for another 7 days at Investigators discretion.
arm group label: nitazoxanide
other name: Viranitta
intervention type: Drug
intervention name: Placebo
description: Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edimilson Migowski, MD
role: Principal Investigator
affiliation: NEPS SEMUS Mesquita
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.