Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
NCT ID: NCT03605862
Last Updated: 2022-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1756 participants
INTERVENTIONAL
2018-09-11
2019-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 5 days
Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for five days
Placebo
Two placebo tablets orally twice daily for 5 days
Placebo
Placebo administered orally twice daily for five days
Interventions
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Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for five days
Placebo
Placebo administered orally twice daily for five days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Romark Laboratories L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Francois Rossignol, M.D., Ph.D
Role: STUDY_DIRECTOR
Romark Laboratories L.C.
Locations
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Vanguard Study Site
Birmingham, Alabama, United States
Vanguard Study Site
Birmingham, Alabama, United States
Vanguard Study Site
Pelham, Alabama, United States
Vanguard Study Site
Hot Springs, Arkansas, United States
Vanguard Study Site
Anaheim, California, United States
Vanguard Study Site
Westminster, California, United States
Vanguard Study Site
Wilmington, California, United States
Vanguard Study Site
Miami, Florida, United States
Vanguard Study Site
Miami, Florida, United States
Vanguard Study Site
Miami, Florida, United States
Vanguard Study Site
Orlando, Florida, United States
Vanguard Study Site
Tampa, Florida, United States
Vanguard Study Site
Stockbridge, Georgia, United States
Vanguard Study Site
Blackfoot, Idaho, United States
Vanguard Study Site
Meridian, Idaho, United States
Vanguard Study Site
Nampa, Idaho, United States
Vanguard Study Site
Evanston, Illinois, United States
Vanguard Study Site
Valparaiso, Indiana, United States
Vanguard Study Site
Louisville, Kentucky, United States
Vanguard Study Site
New Orleans, Louisiana, United States
Vanguard Study Site
New Orleans, Louisiana, United States
Vanguard Study Site
Baltimore, Maryland, United States
Vanguard Study Site
St Louis, Missouri, United States
Vanguard Study Site
Missoula, Montana, United States
Vanguard Study Site
Bellevue, Nebraska, United States
Vanguard Study Site
Las Vegas, Nevada, United States
Vanguard Study Site
Brooklyn, New York, United States
Vanguard Study Site
Raleigh, North Carolina, United States
Vanguard Study Site
Cincinnati, Ohio, United States
Vanguard Study Site
Cleveland, Ohio, United States
Vanguard Study Site
Columbus, Ohio, United States
Vanguard Study Site
Dayton, Ohio, United States
Vanguard Study Site
Medford, Oregon, United States
Vanguard Study Site
East Providence, Rhode Island, United States
Vanguard Study Site
Jackson, Tennessee, United States
Vanguard Study Site
Milan, Tennessee, United States
Vanguard Study Site
Austin, Texas, United States
Vanguard Study Site
Carrollton, Texas, United States
Vanguard Study Site
Houston, Texas, United States
Vanguard Study Site
McAllen, Texas, United States
Vanguard Study Site
Plano, Texas, United States
Vanguard Study Site
Bountiful, Utah, United States
Vanguard Study Site
St. George, Utah, United States
Vanguard Study Site
Ponce, , Puerto Rico
Vanguard Study Site
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RM08-3005
Identifier Type: -
Identifier Source: org_study_id
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