Trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,756
Nitazoxanide 600 mg administered orally twice daily for five days
Placebo administered orally twice daily for five days
Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)
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.
Time frame: Up to 21 days
Time From First Dose to Ability to Perform All Normal Activities
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.
Time frame: Up to 21 days
Proportions Experiencing Complications of EV/RV Infection
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.
Time frame: 28 days
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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
...and 35 more locations