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History of Changes for Study: NCT04489381
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Latest version (submitted December 29, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 23, 2020 None (earliest Version on record)
2 July 28, 2020 Study Status and Study Identification
3 August 14, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 October 28, 2020 Contacts/Locations and Study Status
5 December 29, 2020 Study Status, Contacts/Locations and Eligibility
Comparison Format:

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Study NCT04489381
Submitted Date:  July 23, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: RM08-3009
Brief Title: 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: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2020
Overall Status: Not yet recruiting
Study Start: July 30, 2020
Primary Completion: November 30, 2020 [Anticipated]
Study Completion: November 30, 2020 [Anticipated]
First Submitted: July 23, 2020
First Submitted that
Met QC Criteria:
July 23, 2020
First Posted: July 28, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
July 23, 2020
Last Update Posted: July 28, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Romark Laboratories L.C.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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
Open or close this module Conditions
Conditions: Enterovirus
Rhinovirus
Keywords: Enterovirus
Rhinovirus
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 800 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Nitazoxanide
Two nitazoxanide 300 mg tablets orally twice daily for 5 days
Drug: Nitazoxanide
Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
Other Names:
  • NTZ (nitazoxanide)
  • NT-300
Dietary Supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Placebo Comparator: Placebo
Two placebo tablets orally twice daily for 5 days
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age: 120 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 48 hours before enrollment in the trial. Onset of symptoms is defined as the first time at which the subject experienced 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 with oral temperature ≥100.4°F.
  • 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.
  • 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 medications.
  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Stefan Comhaire
Telephone: 813-282-8544
Email: stefan.comhaire@celerion.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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