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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03605862
Recruitment Status : Completed
First Posted : July 30, 2018
Results First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Brief Summary:
Trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection

Condition or disease Intervention/treatment Phase
Enterovirus Rhinovirus Drug: Nitazoxanide Drug: Placebo Phase 3

Detailed Description:
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Actual Study Start Date : September 11, 2018
Actual Primary Completion Date : February 4, 2019
Actual Study Completion Date : February 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 5 days
Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for five days
Other Names:
  • NTZ (nitazoxanide)
  • NT-300

Placebo Comparator: Placebo
Two placebo tablets orally twice daily for 5 days
Drug: Placebo
Placebo administered orally twice daily for five days




Primary Outcome Measures :
  1. Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint) [ Time Frame: Up to 21 days ]
    Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 32 FLU-PRO symptoms was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 32 symptom thresholds most closely associated with patient-reported usual health.


Secondary Outcome Measures :
  1. Time From First Dose to Ability to Perform All Normal Activities [ Time Frame: Up to 21 days ]
    Subjects completed a diary including rating ability to perform normal activities on a scale from 0 (able to perform no normal activities) to 10 (able to perform all normal activities) daily in the evening. The time from first dose to ability to perform all normal activities is the time in hours between the first dose of study medication and that time when the subject first reported a score of "10" (able to perform all normal activities) for two consecutive daily diary periods without use of symptom relief medication.

  2. Proportions Experiencing Complications of EV/RV Infection [ Time Frame: 28 days ]
    Complications of colds due to EV/RV infection include pneumonia, otitis media, bronchitis, sinusitis, exacerbations of asthma or COPD, worsening of pre-existing health conditions, secondary infections requiring systemic antibiotic use, hospitalization due to cold or complications of the cold, and death due to cold or complications of the cold. Proportions experiencing complications of EV/RV infection were compared across treatment groups.


Other Outcome Measures:
  1. Time to Return to Usual Health [ Time Frame: 21 days ]
    Subjects completed the FLU-PRO questionnaire including global assessment questions daily in the evening. The time from first dose to ability to return to usual health is the time in hours from the first dose of study medication to the first time when the subject answered "Have you returned to your usual health?" with "yes" for two consecutive daily diary periods without the use of symptom relief medication.

  2. Proportion Positive for EV/RV by RT-PCR at Days 2, 3 and 7 [ Time Frame: Days 2, 3, and 7 ]
    Proportion of subjects with nasopharyngeal swab collected testing positive for Enterovirus/Rhinovirus (EV/RV) infection by RT-PCR at each time point.

  3. Analysis of Change From Baseline to Days 2, 3 and 7 in EV/RV Virus Titer [ Time Frame: Days 2, 3, and 7 ]
    Changes from baseline to day 2, baseline to day 3, and baseline to day 7 in EV/RV virus titer measured by quantitative RT-PCR. Samples negative for EV/RV were assigned the value of the limit of detection for the RT-PCR assay.

  4. Response Misclassification Rate Compared to Usual Health [ Time Frame: 21 days ]
    The proportion of patient diaries misclassified by the response definition used for the primary efficacy analysis compared to patient reported usual health. A diary was considered "misclassified" if the response definition predicted "responded" and the patient reported not being at usual health or if the response definition predicted "not responded" and the patient reported being at usual health.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects at least 12 years of age
  2. Presence of clinical signs and/or symptoms consistent with an acute illness compatible with EV/RV infection (each of the following is required):

    1. Presence of moderate or severe rhinorrhea defined as "attempting to relieve nasal symptoms by blowing, wiping, or sniffling at least twice per hour for any one hour within 12 hours preceding study entry," AND
    2. Presence of cough, sore throat or nasal obstruction.
  3. Negative rapid influenza diagnostic test (required only if the subject has an oral temperature >100°F in the clinic or if the latest CDC weekly influenza report shows influenza prevalence "Regional" or higher for the institution's state). A result from a rapid influenza diagnostic test performed on the same day that informed consent is obtained will be sufficient to meet this criterion if documentation of test results is available as part of medical history.
  4. Onset of illness no more than 40 hours before enrollment in the trial. Onset of illness is defined as the first time at which the subject experienced rhinorrhea, cough, sore throat or nasal obstruction.
  5. 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

Exclusion Criteria:

  1. Persons requiring or anticipated to require in-hospital care
  2. Cystic fibrosis
  3. Cardiac arrhythmia
  4. Immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
  5. Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months
  6. Persons with sickle cell anemia or other hemoglobinopathies
  7. Poorly controlled insulin-dependent diabetes mellitus (HbA1C >8.0%)
  8. Concurrent infection at the screening examination that requires systemic antimicrobial therapy
  9. 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 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.
  10. Females who are breastfeeding
  11. Receipt of any dose of NTZ within 30 days prior to screening
  12. Prior treatment with any investigational drug therapy within 30 days prior to screening
  13. Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies
  14. Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets
  15. Subjects unable to take oral medications
  16. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605862


Locations
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United States, Alabama
Vanguard Study Site
Birmingham, Alabama, United States, 35235
Vanguard Study Site
Birmingham, Alabama, United States, 35242
Vanguard Study Site
Pelham, Alabama, United States, 35124
United States, Arkansas
Vanguard Study Site
Hot Springs, Arkansas, United States, 71913
United States, California
Vanguard Study Site
Anaheim, California, United States, 92805
Vanguard Study Site
Westminster, California, United States, 92683
Vanguard Study Site
Wilmington, California, United States, 90744
United States, Florida
Vanguard Study Site
Miami, Florida, United States, 33145
Vanguard Study Site
Miami, Florida, United States, 33155
Vanguard Study Site
Miami, Florida, United States, 33174
Vanguard Study Site
Orlando, Florida, United States, 32819
Vanguard Study Site
Tampa, Florida, United States, 33609
United States, Georgia
Vanguard Study Site
Stockbridge, Georgia, United States, 30281
United States, Idaho
Vanguard Study Site
Blackfoot, Idaho, United States, 83221
Vanguard Study Site
Meridian, Idaho, United States, 83642
Vanguard Study Site
Nampa, Idaho, United States, 83686
United States, Illinois
Vanguard Study Site
Evanston, Illinois, United States, 60201
United States, Indiana
Vanguard Study Site
Valparaiso, Indiana, United States, 46383
United States, Kentucky
Vanguard Study Site
Louisville, Kentucky, United States, 40207
United States, Louisiana
Vanguard Study Site
New Orleans, Louisiana, United States, 70115
Vanguard Study Site
New Orleans, Louisiana, United States, 70124
United States, Maryland
Vanguard Study Site
Baltimore, Maryland, United States, 21236
United States, Missouri
Vanguard Study Site
Saint Louis, Missouri, United States, 63141
United States, Montana
Vanguard Study Site
Missoula, Montana, United States, 59808
United States, Nebraska
Vanguard Study Site
Bellevue, Nebraska, United States, 68005
United States, Nevada
Vanguard Study Site
Las Vegas, Nevada, United States, 89104
United States, New York
Vanguard Study Site
Brooklyn, New York, United States, 11229
United States, North Carolina
Vanguard Study Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Vanguard Study Site
Cincinnati, Ohio, United States, 45215
Vanguard Study Site
Cleveland, Ohio, United States, 44122
Vanguard Study Site
Columbus, Ohio, United States, 43214
Vanguard Study Site
Dayton, Ohio, United States, 45424
United States, Oregon
Vanguard Study Site
Medford, Oregon, United States, 97504
United States, Rhode Island
Vanguard Study Site
East Providence, Rhode Island, United States, 02914
United States, Tennessee
Vanguard Study Site
Jackson, Tennessee, United States, 38305
Vanguard Study Site
Milan, Tennessee, United States, 38328
United States, Texas
Vanguard Study Site
Austin, Texas, United States, 78735
Vanguard Study Site
Carrollton, Texas, United States, 75010
Vanguard Study Site
Houston, Texas, United States, 77058
Vanguard Study Site
McAllen, Texas, United States, 78504
Vanguard Study Site
Plano, Texas, United States, 75024
United States, Utah
Vanguard Study Site
Bountiful, Utah, United States, 84010
Vanguard Study Site
Saint George, Utah, United States, 84790
Puerto Rico
Vanguard Study Site
Ponce, Puerto Rico, 00780
Vanguard Study Site
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
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Study Director: Jean-Francois Rossignol, M.D., Ph.D Romark Laboratories L.C.
  Study Documents (Full-Text)

Documents provided by Romark Laboratories L.C.:
Study Protocol  [PDF] November 29, 2018
Statistical Analysis Plan  [PDF] July 1, 2019

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Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT03605862    
Other Study ID Numbers: RM08-3005
First Posted: July 30, 2018    Key Record Dates
Results First Posted: April 14, 2022
Last Update Posted: April 14, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romark Laboratories L.C.:
Enterovirus
Rhinovirus
Additional relevant MeSH terms:
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Enterovirus Infections
Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents