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Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

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ClinicalTrials.gov Identifier: NCT04489381
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Tracking Information
First Submitted Date  ICMJE July 23, 2020
First Posted Date  ICMJE July 28, 2020
Last Update Posted Date December 31, 2020
Actual Study Start Date  ICMJE August 13, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
Time from First Dose to Sustained Response [ Time Frame: 21 days ]
Time from First Dose to Sustained Response in Subjects with Laboratory-Confirmed Enterovirus/Rhinovirus Infection based upon the FLU-PRO Instrument
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
Proportion of Subjects Requiring Systemic Antibiotics [ Time Frame: 21 days ]
Proportion of Subjects Requiring Systemic Antibiotics for an Infection Secondary to Enterovirus/Rhinovirus, including pneumonia, otitis media, bronchitis, sinusitis or pharyngitis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Official Title  ICMJE 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
Brief Summary Trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection
Detailed Description Multicenter, randomized, double-blind trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Enterovirus
  • Rhinovirus
Intervention  ICMJE
  • Drug: Nitazoxanide
    Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
    Other Names:
    • NTZ (nitazoxanide)
    • NT-300
  • Drug: Placebo
    Two placebo tablets administered orally twice daily with food for 5 days
  • Dietary Supplement: Vitamin Super B-Complex
    Vitamin Super B-Complex administered orally twice daily to maintain the blind
Study Arms  ICMJE
  • Active Comparator: Nitazoxanide
    Two nitazoxanide 300 mg tablets orally twice daily for 5 days
    Interventions:
    • Drug: Nitazoxanide
    • Dietary Supplement: Vitamin Super B-Complex
  • Placebo Comparator: Placebo
    Two placebo tablets orally twice daily for 5 days
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Vitamin Super B-Complex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2020)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female outpatients at least 12 years of age
  • Presence of clinical signs and/or symptoms consistent with worsening or stable cold due to Enterovirus/Rhinovirus infection (one of the following is required):

    1. Presence of at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO OR
    2. Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with pulse rate ≥90 OR
    3. Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with respiratory rate ≥16

AND patient reported assessment that symptoms are present, the symptoms are not consistent with the subject's usual health, the symptoms interfere with daily activities, and the symptoms have worsened or remained the same relative to the previous day, as confirmed by responses to questions in the Screening FLU-PRO.

  • Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of symptoms is defined as the earlier of the first time at which the subject experienced subjective fever or any respiratory symptom (head, throat, nose, chest, or cough symptoms).
  • Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the subject diary and all protocol procedures.

Exclusion Criteria:

  • Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions within two weeks prior to and including study day 1.
  • Severely immunodeficient persons including:

    1. Subjects with immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases).
    2. Subjects with untreated human immunodeficiency viruses (HIV) infection or treated human immunodeficiency viruses (HIV) infection with a CD4 count below 350 cells/mm3 in the last six months.
    3. Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for malignancy.
    4. Subjects using steroids as maintenance therapy for a chronic condition.
  • Subjects with active respiratory allergies or subjects expected to require anti- allergy medications during the study period for respiratory allergies.
  • Females of childbearing potential who are either pregnant or sexually active without the use of birth control. Female subjects of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an Intrauterine Device (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral oophorectomy.
  • Subjects residing in the same household with another subject participating in the study.
  • Treatment with any investigational drug or vaccine therapy within 30 days prior to screening and willing to avoid them during the course of the study.
  • Receipt of any dose of nitazoxanide (NTZ) within seven days prior to screening.
  • Known sensitivity to nitazoxanide (NTZ) or any of the excipients comprising the study medication.
  • Subjects unable to swallow oral tablets or capsules.
  • Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
  • Subjects likely or expected to require hospitalization unrelated to cold during the study period.
  • Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol including completion of the subject diary.
  • Subjects taking medications considered to be major CYP2C8 substrates.
  • Persons with any clinical sign or symptoms suggestive of severe systemic illness with COVID-19, including the following:

    1. shortness of breath at rest,
    2. resting pulse ≥125 beats per minute,
    3. resting respiratory rate ≥ breaths per minute, or
    4. SpO2 ≤ 93% on room air at sea level.
  • Subjects known to have a diagnostic test positive for SARS-CoV-2 or influenza infection within the preceding three weeks.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew Bardin 813-282-8544 matthew.bardin@romark.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04489381
Other Study ID Numbers  ICMJE RM08-3009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Romark Laboratories L.C.
Study Sponsor  ICMJE Romark Laboratories L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Romark Laboratories L.C.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP