Trial · NCT02057757
Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness
NCT02057757, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2018-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness. Trials, record NCT02057757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02057757
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness
- NCT number
- NCT02057757
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 260 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Severe Acute Respiratory Illness
- Interventions
- Nitazoxanide, Placebo
- First posted
- 2014-02-07
- Last updated
- 2018-08-01
- Results first posted
- 2018-07-31
- Limitations and caveats
- There were no significant limitations of the study.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Hospital Discharge | Measured through Day 28 | The time to hospital discharge measured through Day 28. |
| Secondary | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Measured at Day 3, Day 7, Day 14, and Day 28 | The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28. |
| Secondary | Number of Participants Who Died Within the First 5 Days | Measured within First 5 Days | Total Deaths of Participants, including Deaths within First 5 Days |
| Secondary | Number of Participants Who Experienced Clinical Symptoms | Measured through Day 28 | Measured daily through Study Day 14 and then again on Study Day 28 |
| Secondary | Duration of Fever in Study Participants | Measured each day through Day 14 and on Day 28 | Study participants' duration (hours) of fever measured daily through Day 14 and then again on Day 28. The total duration in hours from the visit when fever was registered for the study participant until the next visit when no fever was registered for the study participant. |
| Secondary | Number of Participants Who Require Oxygen Use | Measured through Day 28 or participants' last day of hospitalization | Number of study participants who require use of supplemental oxygen at time points (e.g., Any time, Day 0, Day 3, Day 7, Day 14, and Day 28) |
| Secondary | Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28) | Measured through Day 28 or participants' last day in the ICU | Number of study participants (e.g., adult and children) admitted to the intensive care unit (ICU) by time point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed. |
| Secondary | Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28) | Measured through Day 28 or participants' last day of hospitalization | Study participants (e.g., adults, children) requiring mechanical ventilation (e.g., intubation/extubation) at study time points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed. |
| Secondary | Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study | Measured through Day 28 or participants' last day of hospitalization | Number of study participants (e.g., adults and children) with the presence of a complication (pneumonia, respiratory failure requiring mechanical ventilation, acute respiratory distress syndrome \[ARDS\], sepsis, or bronchiolitis) during the study . |
| Secondary | Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children) | Measured daily through Day 14 and on Day 28 | Study participant (e.g., adults and children) answers (e.g., yes) to global assessment questions measured daily through Day 14 and then again on Day 28. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Hospital Discharge | Measured through Day 28 | Days | MEAN | |
| SECONDARY | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Measured at Day 3, Day 7, Day 14, and Day 28 | Number of study participants - adults (\>= 18 years) and children (\< 18 years) in the Intent-to-Treat population (ITT) hospitalized by time point | participants | NUMBER |
| SECONDARY | Number of Participants Who Died Within the First 5 Days | Measured within First 5 Days | The Adult (\>=18 Years) population includes 126 participants (63 in NTZ arm; 63 in Placebo arm). The Children (\<18 Years) population includes 131 participants (67 in NTZ arm; 64 in Placebo arm) | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced Clinical Symptoms | Measured through Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Fever in Study Participants | Measured each day through Day 14 and on Day 28 | hours | MEAN | |
| SECONDARY | Number of Participants Who Require Oxygen Use | Measured through Day 28 or participants' last day of hospitalization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28) | Measured through Day 28 or participants' last day in the ICU | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28) | Measured through Day 28 or participants' last day of hospitalization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study | Measured through Day 28 or participants' last day of hospitalization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children) | Measured daily through Day 14 and on Day 28 | days | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Hospital Discharge | Nitazoxanide (NTZ) | 7.1 | Standard Error 0.37 | Days | |
| Time to Hospital Discharge | Placebo | 7.5 | Standard Error 0.41 | Days | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Nitazoxanide (NTZ) | Day 3 | 95 | participants | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Placebo | Day 3 | 96 | participants | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Nitazoxanide (NTZ) | Day 7 | 39 | participants | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Placebo | Day 7 | 38 | participants | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Nitazoxanide (NTZ) | Day 14 | 7 | participants | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Placebo | Day 14 | 6 | participants | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Nitazoxanide (NTZ) | Day 28 | 3 | participants | |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Placebo | Day 28 | 2 | participants |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nitazoxanide (NTZ) | 131 | |
| Overall Study | STARTED | Placebo | 129 | |
| Overall Study | Intent to Treat | Nitazoxanide (NTZ) | 130 | |
| Overall Study | Intent to Treat | Placebo | 127 | |
| Overall Study | COMPLETED | Nitazoxanide (NTZ) | 117 | |
| Overall Study | COMPLETED | Placebo | 121 | |
| Overall Study | NOT COMPLETED | Nitazoxanide (NTZ) | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomitting | Gastrointestinal disorders | Nitazoxanide (NTZ) | 8 | 130 | 9 |
| other | Vomitting | Gastrointestinal disorders | Placebo | 14 | 127 | 14 |
| other | Pyrexia | General disorders | Nitazoxanide (NTZ) | 8 | 130 | 8 |
| other | Pyrexia | General disorders | Placebo | 5 | 127 | 5 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Nitazoxanide (NTZ) | 10 | 130 | 10 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Placebo | 7 | 127 | 7 |
| serious | Neutropenia | Blood and lymphatic system disorders | Nitazoxanide (NTZ) | 0 | 130 | 0 |
| serious | Neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 127 | 1 |
| serious | Aspergillosis | Infections and infestations | Nitazoxanide (NTZ) | 1 | 130 | 1 |
| serious | Aspergillosis | Infections and infestations | Placebo | 0 | 127 | 0 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nitazoxanide (NTZ) | 2 | 130 |
| Total, all-cause mortality | Placebo | 1 | 127 |
| Total, other adverse events | Nitazoxanide (NTZ) | 26 | 130 |
| Total, other adverse events | Placebo | 26 | 127 |
| Total, serious adverse events | Nitazoxanide (NTZ) | 6 | 130 |
| Total, serious adverse events | Placebo | 3 | 127 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30753384 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nitazoxanide (NTZ) vs Placebo: Number of Participants Reporting Serious Adverse Events (SAEs) | Trial comparisons |
| Nitazoxanide (NTZ) vs Placebo: Number of Participants Reporting Adverse Events (AEs) | Trial comparisons |
| Nitazoxanide (NTZ) vs Placebo: deaths from any cause | Trial comparisons |
| Nitazoxanide (NTZ) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02057757
GET https://conductscience.org/api/trials/v1/NCT02057757/registered?page=2