<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/NCT04489381</url>
  </required_header>
  <id_info>
    <org_study_id>RM08-3009</org_study_id>
    <nct_id>NCT04489381</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection</brief_title>
  <official_title>Phase 3, A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Romark Laboratories L.C.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Romark Laboratories L.C.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to&#xD;
      enterovirus/rhinovirus infection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicenter, randomized, double-blind trial to evaluate the efficacy and safety of&#xD;
      nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from First Dose to Sustained Response</measure>
    <time_frame>21 days</time_frame>
    <description>Time from First Dose to Sustained Response in Subjects with Laboratory-Confirmed Enterovirus/Rhinovirus Infection based upon the FLU-PRO Instrument</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Requiring Systemic Antibiotics</measure>
    <time_frame>21 days</time_frame>
    <description>Proportion of Subjects Requiring Systemic Antibiotics for an Infection Secondary to Enterovirus/Rhinovirus, including pneumonia, otitis media, bronchitis, sinusitis or pharyngitis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Enterovirus</condition>
  <condition>Rhinovirus</condition>
  <arm_group>
    <arm_group_label>Nitazoxanide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two nitazoxanide 300 mg tablets orally twice daily for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two placebo tablets orally twice daily for 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitazoxanide</intervention_name>
    <description>Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days</description>
    <arm_group_label>Nitazoxanide</arm_group_label>
    <other_name>NTZ (nitazoxanide)</other_name>
    <other_name>NT-300</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Two placebo tablets administered orally twice daily with food for 5 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin Super B-Complex</intervention_name>
    <description>Vitamin Super B-Complex administered orally twice daily to maintain the blind</description>
    <arm_group_label>Nitazoxanide</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female outpatients at least 12 years of age&#xD;
&#xD;
          -  Presence of clinical signs and/or symptoms consistent with worsening or stable cold&#xD;
             due to Enterovirus/Rhinovirus infection (one of the following is required):&#xD;
&#xD;
               1. Presence of at least two respiratory symptom domains (head, throat, nose, chest,&#xD;
                  cough) with a score of ≥2 as determined by Screening FLU-PRO OR&#xD;
&#xD;
               2. Presence of at least one respiratory symptom domain (head, throat, nose, chest,&#xD;
                  cough) with a score of ≥2 as determined by Screening FLU-PRO with pulse rate ≥90&#xD;
                  OR&#xD;
&#xD;
               3. Presence of at least one respiratory symptom domain (head, throat, nose, chest,&#xD;
                  cough) with a score of ≥2 as determined by Screening FLU-PRO with respiratory&#xD;
                  rate ≥16&#xD;
&#xD;
        AND patient reported assessment that symptoms are present, the symptoms are not consistent&#xD;
        with the subject's usual health, the symptoms interfere with daily activities, and the&#xD;
        symptoms have worsened or remained the same relative to the previous day, as confirmed by&#xD;
        responses to questions in the Screening FLU-PRO.&#xD;
&#xD;
          -  Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of&#xD;
             symptoms is defined as the earlier of the first time at which the subject experienced&#xD;
             subjective fever or any respiratory symptom (head, throat, nose, chest, or cough&#xD;
             symptoms).&#xD;
&#xD;
          -  Willing and able to provide written informed consent (including assent by legal&#xD;
             guardian if under 18 years of age) and comply with the requirements of the protocol,&#xD;
             including completion of the subject diary and all protocol procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who experienced a previous episode of acute upper respiratory tract&#xD;
             infection, otitis, bronchitis or sinusitis or received antibiotics for these&#xD;
             conditions within two weeks prior to and including study day 1.&#xD;
&#xD;
          -  Severely immunodeficient persons including:&#xD;
&#xD;
               1. Subjects with immunologic disorders or receiving immunosuppressive therapy (e.g.,&#xD;
                  for organ or bone marrow transplants, immunomodulatory therapies for certain&#xD;
                  autoimmune diseases).&#xD;
&#xD;
               2. Subjects with untreated human immunodeficiency viruses (HIV) infection or treated&#xD;
                  human immunodeficiency viruses (HIV) infection with a CD4 count below 350&#xD;
                  cells/mm3 in the last six months.&#xD;
&#xD;
               3. Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for&#xD;
                  malignancy.&#xD;
&#xD;
               4. Subjects using steroids as maintenance therapy for a chronic condition.&#xD;
&#xD;
          -  Subjects with active respiratory allergies or subjects expected to require anti-&#xD;
             allergy medications during the study period for respiratory allergies.&#xD;
&#xD;
          -  Females of childbearing potential who are either pregnant or sexually active without&#xD;
             the use of birth control. Female subjects of child-bearing potential that are sexually&#xD;
             active must have a negative baseline pregnancy test and must agree to continue an&#xD;
             acceptable method of birth control for the duration of the study and for 1 month&#xD;
             post-treatment. A double barrier method, oral birth control pills administered for at&#xD;
             least 2 monthly cycles prior to study drug administration, an Intrauterine Device&#xD;
             (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of&#xD;
             one month prior to study drug administration are acceptable methods of birth control&#xD;
             for inclusion into the study. Female subjects are considered of childbearing potential&#xD;
             unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months&#xD;
             if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral&#xD;
             tubular ligation or bilateral oophorectomy.&#xD;
&#xD;
          -  Subjects residing in the same household with another subject participating in the&#xD;
             study.&#xD;
&#xD;
          -  Treatment with any investigational drug or vaccine therapy within 30 days prior to&#xD;
             screening and willing to avoid them during the course of the study.&#xD;
&#xD;
          -  Receipt of any dose of nitazoxanide (NTZ) within seven days prior to screening.&#xD;
&#xD;
          -  Known sensitivity to nitazoxanide (NTZ) or any of the excipients comprising the study&#xD;
             medication.&#xD;
&#xD;
          -  Subjects unable to swallow oral tablets or capsules.&#xD;
&#xD;
          -  Subjects with known severe heart, lung, neurological or other systemic disease that&#xD;
             the Investigator believes could preclude safe participation.&#xD;
&#xD;
          -  Subjects likely or expected to require hospitalization unrelated to cold during the&#xD;
             study period.&#xD;
&#xD;
          -  Subjects who, in the judgment of the Investigator, will be unlikely to comply with the&#xD;
             requirements of this protocol including completion of the subject diary.&#xD;
&#xD;
          -  Subjects taking medications considered to be major CYP2C8 substrates.&#xD;
&#xD;
          -  Persons with any clinical sign or symptoms suggestive of severe systemic illness with&#xD;
             COVID-19, including the following:&#xD;
&#xD;
               1. shortness of breath at rest,&#xD;
&#xD;
               2. resting pulse ≥125 beats per minute,&#xD;
&#xD;
               3. resting respiratory rate ≥ breaths per minute, or&#xD;
&#xD;
               4. SpO2 ≤ 93% on room air at sea level.&#xD;
&#xD;
          -  Subjects known to have a diagnostic test positive for SARS-CoV-2 or influenza&#xD;
             infection within the preceding three weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matthew Bardin</last_name>
    <phone>813-282-8544</phone>
    <email>matthew.bardin@romark.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>HealthStar Research LLC</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romark</last_name>
      <phone>877-925-4642</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Invesclinic US LLC</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romark</last_name>
      <phone>877-925-4642</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>RH Medical Urgent Care</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10456</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romark</last_name>
      <phone>877-925-4642</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>December 29, 2020</last_update_submitted>
  <last_update_submitted_qc>December 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Enterovirus</keyword>
  <keyword>Rhinovirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterovirus 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>
  <!-- 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/NCT04489381
org study id: RM08-3009
nct id: NCT04489381
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to
      enterovirus/rhinovirus infection
Multicenter, randomized, double-blind trial to evaluate the efficacy and safety of
      nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Time from First Dose to Sustained Response
time frame: 21 days
description: Time from First Dose to Sustained Response in Subjects with Laboratory-Confirmed Enterovirus/Rhinovirus Infection based upon the FLU-PRO Instrument
measure: Proportion of Subjects Requiring Systemic Antibiotics
time frame: 21 days
description: Proportion of Subjects Requiring Systemic Antibiotics for an Infection Secondary to Enterovirus/Rhinovirus, including pneumonia, otitis media, bronchitis, sinusitis or pharyngitis
arm group label: Nitazoxanide
arm group type: Active Comparator
description: Two nitazoxanide 300 mg tablets orally twice daily for 5 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Two placebo tablets orally twice daily for 5 days
intervention type: Drug
intervention name: Nitazoxanide
description: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
arm group label: Nitazoxanide
other name: NTZ (nitazoxanide)
other name: NT-300
intervention type: Drug
intervention name: Placebo
description: Two placebo tablets administered orally twice daily with food for 5 days
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Vitamin Super B-Complex
description: Vitamin Super B-Complex administered orally twice daily to maintain the blind
arm group label: Nitazoxanide
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 120 Years
healthy volunteers: No
last name: Matthew Bardin
phone: 813-282-8544
email: matthew.bardin@romark.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Enterovirus Infections
mesh term: Nitazoxanide