<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/NCT04406246</url>
  </required_header>
  <id_info>
    <org_study_id>2020-04-682</org_study_id>
    <nct_id>NCT04406246</nct_id>
  </id_info>
  <brief_title>Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide</brief_title>
  <official_title>Prevention of Coronavirus Disease (COVID-19) Outbreaks by Prophylactic Treatment With Nitazoxanide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Materno-Perinatal Hospital of the State of Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratorios Liomont</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Materno-Perinatal Hospital of the State of Mexico</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 new coronavirus outbreak has led to a public health emergency of international concern,&#xD;
      putting all health organizations on high alert. As part of the hygienic measures, isolation&#xD;
      and reinforcement cleaning strategies have been followed. It is known that special attention&#xD;
      and efforts should be applied to protect or reduce transmission in susceptible populations,&#xD;
      including the elderly or those with comorbidities.It has also been proposed a semaforization&#xD;
      to classify patients with respiratory symptoms based on: Fever (38ºC or more), dry cough,&#xD;
      headache, dyspnea, joint pain, muscle pain, sore throat, nose discharge, conjunctivitis,&#xD;
      chest pain, diarrhea, anosmia, ageusia.&#xD;
&#xD;
      Nitazoxanide has shown to be effective against several viruses, of both types RNA and DNA,&#xD;
      including other coronavirus that produced the Severe Acute Respiratory Syndrome (SARS) and&#xD;
      the Middle East Respiratory Syndrome (MERS).&#xD;
&#xD;
      Facing the lack of options against COVID-19 outbreaks for example in health workers,&#xD;
      nitazoxanide could contribute to decrease the contagious dissemination of SARS-CoV-2, thus&#xD;
      reducing at the same time the Hospital saturation of patients positive to this virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronaviruses (CoV) are positive-stranded single-stranded RNA viruses that infect a wide&#xD;
      range of hosts. The new coronavirus outbreak has led to a public health emergency of&#xD;
      international concern, putting all health organizations on high alert.&#xD;
&#xD;
      The accelerated spread pushed physicians to try a variety of treatments without an&#xD;
      established sequence due to ignorance of the disease. As part of the hygienic measures,&#xD;
      isolation and reinforcement cleaning strategies have been followed. With current&#xD;
      epidemiological data, it is known that special attention and efforts should be applied to&#xD;
      reduce the transmission in susceptible populations, including the elderly or those with&#xD;
      comorbidities. On the other hand it has also been proposed a semaforization to classify the&#xD;
      severity of COVID-19 cases.&#xD;
&#xD;
      Nitazoxanide, a drug with antibacterial and anti-protozoal effects, has also powerful&#xD;
      antiviral effects through the phosphorylation of protein-kinase activated by double-stranded&#xD;
      RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein&#xD;
      with antiviral effects. This drug has been effective in vitro against Severe Acute&#xD;
      Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome by Coronavirus (MERS), both&#xD;
      produced by other coronavirus.&#xD;
&#xD;
      Currently all the efforts in the world have been focused on the treatment of COVID-19 since&#xD;
      there is pneumonia, the patient being in hospitalization and even in intensive care units.&#xD;
      Probably, focusing on these late stages has distracted the attention of the initial stage,&#xD;
      this means early treatment to prevent the evolution to critical clinical conditions.&#xD;
&#xD;
      It is hypothesized that the use of nitazoxanide at an early stage of COVID-19 could decrease&#xD;
      the contagious outbreaks of this virus in health workers, and at the same time will reduce&#xD;
      the community dissemination and evolution of cases requiring intensive care units.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 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 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>In this cohort study, all health workers of the Maternal-Perinatal Hospital &quot;Mónica Pretelini Sáenz&quot;, with symptoms of SARS-CoV-2 will be treated promptly with nitazoxanide.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health workers that require hospitalization</measure>
    <time_frame>Two weeks since the begining of symptoms</time_frame>
    <description>The percentage of health workers that require hospitalization after beginning an early treatment with nitazoxanide in case of referring symptoms of COVID-19.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Coronavirus Infection</condition>
  <arm_group>
    <arm_group_label>Nitazoxanide early treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health workers with symptoms of COVID-19 not requiring hospitalization will receive an early treatment with nitazoxanide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitazoxanide 500Mg Oral Tablet</intervention_name>
    <description>Health workers affected by SARS-CoV-2 will receive the next doses of nitazoxanide: 500 mg every 6 hour for two days and then every 12 hours for four days.</description>
    <arm_group_label>Nitazoxanide early treatment</arm_group_label>
    <other_name>Paramix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 positive patients by clinical criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have inherent contraindications to nitazoxanide.&#xD;
&#xD;
          -  Patients with inflammatory bowel disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José Meneses Calderón, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Materno-Perinatal Hospital &quot;Mónica Pretelini&quot;</name>
      <address>
        <city>Toluca</city>
        <zip>50130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Dhama K, Sharun K, Tiwari R, Dadar M, Malik YS, Singh KP, Chaicumpa W. COVID-19, an emerging coronavirus infection: advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. Hum Vaccin Immunother. 2020 Jun 2;16(6):1232-1238. doi: 10.1080/21645515.2020.1735227. Epub 2020 Mar 18.</citation>
    <PMID>32186952</PMID>
  </reference>
  <reference>
    <citation>Mifsud EJ, Tilmanis D, Oh DY, Ming-Kay Tai C, Rossignol JF, Hurt AC. Prophylaxis of ferrets with nitazoxanide and oseltamivir combinations is more effective at reducing the impact of influenza a virus infection compared to oseltamivir monotherapy. Antiviral Res. 2020 Apr;176:104751. doi: 10.1016/j.antiviral.2020.104751. Epub 2020 Feb 20.</citation>
    <PMID>32088248</PMID>
  </reference>
  <reference>
    <citation>Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.</citation>
    <PMID>27095301</PMID>
  </reference>
  <reference>
    <citation>Rossignol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Epub 2014 Aug 7.</citation>
    <PMID>25108173</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Materno-Perinatal Hospital of the State of Mexico</investigator_affiliation>
    <investigator_full_name>Hugo Mendieta Zeron</investigator_full_name>
    <investigator_title>Chief of the Research Department</investigator_title>
  </responsible_party>
  <keyword>evolution</keyword>
  <keyword>nitazoxanide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</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>Undecided</sharing_ipd>
    <ipd_description>The Data will be available upon request after a publication is reached.</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/NCT04406246
org study id: 2020-04-682
nct id: NCT04406246
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The new coronavirus outbreak has led to a public health emergency of international concern,
      putting all health organizations on high alert. As part of the hygienic measures, isolation
      and reinforcement cleaning strategies have been followed. It is known that special attention
      and efforts should be applied to protect or reduce transmission in susceptible populations,
      including the elderly or those with comorbidities.It has also been proposed a semaforization
      to classify patients with respiratory symptoms based on: Fever (38ºC or more), dry cough,
      headache, dyspnea, joint pain, muscle pain, sore throat, nose discharge, conjunctivitis,
      chest pain, diarrhea, anosmia, ageusia.

      Nitazoxanide has shown to be effective against several viruses, of both types RNA and DNA,
      including other coronavirus that produced the Severe Acute Respiratory Syndrome (SARS) and
      the Middle East Respiratory Syndrome (MERS).

      Facing the lack of options against COVID-19 outbreaks for example in health workers,
      nitazoxanide could contribute to decrease the contagious dissemination of SARS-CoV-2, thus
      reducing at the same time the Hospital saturation of patients positive to this virus.
Coronaviruses (CoV) are positive-stranded single-stranded RNA viruses that infect a wide
      range of hosts. The new coronavirus outbreak has led to a public health emergency of
      international concern, putting all health organizations on high alert.

      The accelerated spread pushed physicians to try a variety of treatments without an
      established sequence due to ignorance of the disease. As part of the hygienic measures,
      isolation and reinforcement cleaning strategies have been followed. With current
      epidemiological data, it is known that special attention and efforts should be applied to
      reduce the transmission in susceptible populations, including the elderly or those with
      comorbidities. On the other hand it has also been proposed a semaforization to classify the
      severity of COVID-19 cases.

      Nitazoxanide, a drug with antibacterial and anti-protozoal effects, has also powerful
      antiviral effects through the phosphorylation of protein-kinase activated by double-stranded
      RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein
      with antiviral effects. This drug has been effective in vitro against Severe Acute
      Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome by Coronavirus (MERS), both
      produced by other coronavirus.

      Currently all the efforts in the world have been focused on the treatment of COVID-19 since
      there is pneumonia, the patient being in hospitalization and even in intensive care units.
      Probably, focusing on these late stages has distracted the attention of the initial stage,
      this means early treatment to prevent the evolution to critical clinical conditions.

      It is hypothesized that the use of nitazoxanide at an early stage of COVID-19 could decrease
      the contagious outbreaks of this virus in health workers, and at the same time will reduce
      the community dissemination and evolution of cases requiring intensive care units.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: In this cohort study, all health workers of the Maternal-Perinatal Hospital "Mónica Pretelini Sáenz", with symptoms of SARS-CoV-2 will be treated promptly with nitazoxanide.
primary purpose: Treatment
masking: None (Open Label)
measure: Health workers that require hospitalization
time frame: Two weeks since the begining of symptoms
description: The percentage of health workers that require hospitalization after beginning an early treatment with nitazoxanide in case of referring symptoms of COVID-19.
arm group label: Nitazoxanide early treatment
arm group type: Experimental
description: Health workers with symptoms of COVID-19 not requiring hospitalization will receive an early treatment with nitazoxanide.
intervention type: Drug
intervention name: Nitazoxanide 500Mg Oral Tablet
description: Health workers affected by SARS-CoV-2 will receive the next doses of nitazoxanide: 500 mg every 6 hour for two days and then every 12 hours for four days.
arm group label: Nitazoxanide early treatment
other name: Paramix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: José Meneses Calderón, MD.
role: Principal Investigator
affiliation: Research Unit
facility: 
country: Mexico
citation: Dhama K, Sharun K, Tiwari R, Dadar M, Malik YS, Singh KP, Chaicumpa W. COVID-19, an emerging coronavirus infection: advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. Hum Vaccin Immunother. 2020 Jun 2;16(6):1232-1238. doi: 10.1080/21645515.2020.1735227. Epub 2020 Mar 18.
PMID: 32186952
citation: Mifsud EJ, Tilmanis D, Oh DY, Ming-Kay Tai C, Rossignol JF, Hurt AC. Prophylaxis of ferrets with nitazoxanide and oseltamivir combinations is more effective at reducing the impact of influenza a virus infection compared to oseltamivir monotherapy. Antiviral Res. 2020 Apr;176:104751. doi: 10.1016/j.antiviral.2020.104751. Epub 2020 Feb 20.
PMID: 32088248
citation: Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.
PMID: 27095301
citation: Rossignol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Epub 2014 Aug 7.
PMID: 25108173
responsible party type: Principal Investigator
investigator affiliation: Materno-Perinatal Hospital of the State of Mexico
investigator full name: Hugo Mendieta Zeron
investigator title: Chief of the Research Department
mesh term: Coronavirus Infections
mesh term: Nitazoxanide
sharing ipd: Undecided
ipd description: The Data will be available upon request after a publication is reached.