12 and older, any sex, with Enterovirus or Rhinovirus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)Primary· 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.
Group
Value
95% CI
Nitazoxanide
122.5
58 – 244
Placebo
137.1
75 – 243
Time From First Dose to Ability to Perform All Normal ActivitiesSecondary· 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.
Group
Value
95% CI
Nitazoxanide
174.3
80 – 340
Placebo
175.4
105 – 318
Proportions Experiencing Complications of EV/RV InfectionSecondary· 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.
Group
Value
95% CI
Nitazoxanide
12
Placebo
20
Time to Return to Usual HealthSecondary· 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.
Group
Value
95% CI
Nitazoxanide
154.1
80 – 320
Placebo
174.9
104 – 345
Proportion Positive for EV/RV by RT-PCR at Days 2, 3 and 7Secondary· 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.
Day 2
Group
Value
95% CI
Nitazoxanide
0.81
Placebo
0.81
Day 3
Group
Value
95% CI
Nitazoxanide
0.79
Placebo
0.79
Day 7
Group
Value
95% CI
Nitazoxanide
0.66
Placebo
0.76
Analysis of Change From Baseline to Days 2, 3 and 7 in EV/RV Virus TiterSecondary· 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.
Day 2
Group
Value
95% CI
Nitazoxanide
-0.2203
± 0.0934
Placebo
-0.4186
± 0.0884
Day 3
Group
Value
95% CI
Nitazoxanide
-0.5577
± 0.1272
Placebo
-0.8282
± 0.1053
Day 7
Group
Value
95% CI
Nitazoxanide
-1.5113
± 0.1373
Placebo
-1.6470
± 0.1231
Response Misclassification Rate Compared to Usual HealthSecondary· 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.
Group
Value
95% CI
ITTI Population
0.21915
Correlation Coefficient for Sustained Response and Return to Usual HealthSecondary· 21 days
The correlation coefficient between sustained response and return to usual health was calculated for the pooled ITTI population (i.e., not by treatment group) as a measure of association between the primary endpoint response definition and its intended anchor, patient-reported return to usual health.
Group
Value
95% CI
ITTI Population
0.43
Time to Return to Usual Health, Modified ITTI PopulationSecondary· 21 days
Examination of Baseline disease characteristics revealed many subjects reporting via the Baseline FLU-PRO questionnaire that they are at their usual state of health, that symptoms do not interfere with any usual activities, and/or that symptoms are already improving. The pre-specified analysis of Time to Return for Usual Health was repeated for the population with Baseline subject-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 relati
Group
Value
95% CI
Nitazoxanide
153.7
96 – 317
Placebo
195.0
123 – 365
Time to Sustained Clinical RecoverySecondary· 21 days
Alternative means of endpoint construction were pursued to strengthen the relationship between symptoms-based endpoint measures and subject global assessments of health. Time to Sustained Clinical Recovery is an endpoint based on evidence of meaningful within-subject change sustained for the duration of the study. Time to Sustained Clinical Recovery is the time in hours from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no or
Group
Value
95% CI
Nitazoxanide
171.4
81 – 411
Placebo
221.5
103 – 504
Time to Sustained Clinical Recovery, Modified ITTI PopulationSecondary· 21 days
Analysis of Time to Sustained Clinical Recovery was repeated for the population with Baseline subject-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. Time to Sustained Clinical Recovery is the time in hours from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat bet
Group
Value
95% CI
Nitazoxanide
150.3
81 – 322
Placebo
244.1
119 – 504
Adverse events — posted to ClinicalTrials.gov
Time frame: 28 days or until resolution of all adverse events, whichever occurred later..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Other Romark Laboratories L.C. trials
Trials by the same sponsor.
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NCT03905655 — Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Romark Laboratories L.C.
Last refreshed: 14 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03605862.