Clinical trial NCT03605862: Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Enterovirus
Rhinovirus
Keywords: Enterovirus
Rhinovirus
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 1756
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)
timeFrame: Up to 21 days
Secondary outcomes:
measure: Time From First Dose to Ability to Perform All Normal Activities
timeFrame: Up to 21 days
measure: Proportions Experiencing Complications of EV/RV Infection
timeFrame: 28 days
Other outcomes:
measure: Time to Return to Usual Health
timeFrame: 21 days
measure: Proportion Positive for EV/RV by RT-PCR at Days 2, 3 and 7
timeFrame: Days 2, 3, and 7
measure: Analysis of Change From Baseline to Days 2, 3 and 7 in EV/RV Virus Titer
timeFrame: Days 2, 3, and 7
measure: Response Misclassification Rate Compared to Usual Health
timeFrame: 21 days
Locations:
city: Birmingham
country: United States
facility: Vanguard Study Site
state: Alabama
city: Birmingham
country: United States
facility: Vanguard Study Site
state: Alabama
city: Pelham
country: United States
facility: Vanguard Study Site
state: Alabama
city: Hot Springs
country: United States
facility: Vanguard Study Site
state: Arkansas
city: Anaheim
country: United States
facility: Vanguard Study Site
state: California
city: Westminster
country: United States
facility: Vanguard Study Site
state: California
city: Wilmington
country: United States
facility: Vanguard Study Site
state: California
city: Miami
country: United States
facility: Vanguard Study Site
state: Florida
city: Miami
country: United States
facility: Vanguard Study Site
state: Florida
city: Miami
country: United States
facility: Vanguard Study Site
state: Florida
city: Orlando
country: United States
facility: Vanguard Study Site
state: Florida
city: Tampa
country: United States
facility: Vanguard Study Site
state: Florida
city: Stockbridge
country: United States
facility: Vanguard Study Site
state: Georgia
city: Blackfoot
country: United States
facility: Vanguard Study Site
state: Idaho
city: Meridian
country: United States
facility: Vanguard Study Site
state: Idaho
city: Nampa
country: United States
facility: Vanguard Study Site
state: Idaho
city: Evanston
country: United States
facility: Vanguard Study Site
state: Illinois
city: Valparaiso
country: United States
facility: Vanguard Study Site
state: Indiana
city: Louisville
country: United States
facility: Vanguard Study Site
state: Kentucky
city: New Orleans
country: United States
facility: Vanguard Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Vanguard Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Vanguard Study Site
state: Maryland
city: Saint Louis
country: United States
facility: Vanguard Study Site
state: Missouri
city: Missoula
country: United States
facility: Vanguard Study Site
state: Montana
city: Bellevue
country: United States
facility: Vanguard Study Site
state: Nebraska
city: Las Vegas
country: United States
facility: Vanguard Study Site
state: Nevada
city: Brooklyn
country: United States
facility: Vanguard Study Site
state: New York
city: Raleigh
country: United States
facility: Vanguard Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Vanguard Study Site
state: Ohio
city: Cleveland
country: United States
facility: Vanguard Study Site
state: Ohio
city: Columbus
country: United States
facility: Vanguard Study Site
state: Ohio
city: Dayton
country: United States
facility: Vanguard Study Site
state: Ohio
city: Medford
country: United States
facility: Vanguard Study Site
state: Oregon
city: East Providence
country: United States
facility: Vanguard Study Site
state: Rhode Island
city: Jackson
country: United States
facility: Vanguard Study Site
state: Tennessee
city: Milan
country: United States
facility: Vanguard Study Site
state: Tennessee
city: Austin
country: United States
facility: Vanguard Study Site
state: Texas
city: Carrollton
country: United States
facility: Vanguard Study Site
state: Texas
city: Houston
country: United States
facility: Vanguard Study Site
state: Texas
city: McAllen
country: United States
facility: Vanguard Study Site
state: Texas
city: Plano
country: United States
facility: Vanguard Study Site
state: Texas
city: Bountiful
country: United States
facility: Vanguard Study Site
state: Utah
city: Saint George
country: United States
facility: Vanguard Study Site
state: Utah
city: Ponce
country: Puerto Rico
facility: Vanguard Study Site
city: San Juan
country: Puerto Rico
facility: Vanguard Study Site
Study officials:
affiliation: Romark Laboratories L.C.
name: Jean-Francois Rossignol, M.D., Ph.D
role: STUDY_DIRECTOR
References: