Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT02057757
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbeigel@niaid.nih.gov', 'phone': '301-451-9881', 'title': 'Dr. John Beigel', 'organization': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were no significant limitations of the study.'}}, 'adverseEventsModule': {'timeFrame': 'AEs were recorded for each subject starting at completing the Informed Consent process and continuing until the subject completed study, or until resolution of the adverse event as recorded by the clinical site (up to Day 28).', 'description': 'The definition of AEs and SAEs used to collect AE event information for this study does not differ from the clinicaltrials.gov definitions. The study Investigators evaluated AEs with respect to Seriousness (as per the protocol), Severity (grading), and Causality according to the "DAIDS (Division of AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events" Version 1.0, December 2004: (Clarification August 2009)', 'eventGroups': [{'id': 'EG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 26, 'seriousNumAtRisk': 130, 'deathsNumAffected': 2, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 26, 'seriousNumAtRisk': 127, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Vomitting', 'notes': 'MedDRA System Organ Class and Preferred term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pyrexia', 'notes': 'MedDRA System Organ Class and Preferred Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rhinorrhoea', 'notes': 'MedDRA System Organ Class and Preferred Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': "Immune Reconstitution Inflammatory Syndrome Associated Kaposi's Sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5634', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The equivalence margin is 1.25 Days.'}], 'paramType': 'MEAN', 'timeFrame': 'Measured through Day 28', 'description': 'The time to hospital discharge measured through Day 28.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Hospitalized on Days 3, 7, 14, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.645', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value for each time point was calculated; Day 3', 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.989', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value for each value was calculated (Day 7).', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.809', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 14', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.671', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 28', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Day 3, Day 7, Day 14, and Day 28', 'description': 'The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of study participants - adults (\\>= 18 years) and children (\\< 18 years) in the Intent-to-Treat population (ITT) hospitalized by time point'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Within the First 5 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Total Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deaths within the First 5 Days (Adults >=18) Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Deaths within the First 5 Days (Children<18) Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured within First 5 Days', 'description': 'Total Deaths of Participants, including Deaths within First 5 Days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Clinical Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Cough', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Sore Throat', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Discharge', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty Breathing', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Pain', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4277', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Cough', 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4022', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Sore Throat', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5957', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Fatigue', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0446', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Nasal Discharge', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8628', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difficulty Breathing', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Headache', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1234', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Muscle Pain', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2155', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Nausea', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5176', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Vomiting', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6986', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Diarrhea', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Day 28', 'description': 'Measured daily through Study Day 14 and then again on Study Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Fever in Study Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '5.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9850', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured each day through Day 14 and on Day 28', 'description': "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.", 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Require Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Any Time', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Day 0', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.681', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Any Time', 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.341', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 0', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.321', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 3', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.957', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 7', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.788', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 14', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.544', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 28', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': '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)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Any Time', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.671', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Any Time', 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 0', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 3', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 7', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.311', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 14', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Measured through Day 28 or participants' last day in the ICU", 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Any Time', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.973', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Any Time', 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 0', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.548', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 3', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 7', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 14', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 28', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Failure Requiring Mechanical Vent.', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute Respiratory Distress Syndrome (ARDS)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Sepsis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.928', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Pneumonia', 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9669', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'ARDS', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0832', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Bronchitis', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': '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 .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ) - Adults >=18 Years', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo - Adults >=18 Years', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}, {'id': 'OG002', 'title': 'Nitazoxanide (NTZ) - Children <18 Years', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG003', 'title': 'Placebo - Children <18 Years', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Have you felt as good as you did before?', 'categories': [{'measurements': [{'value': '10.2', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.63', 'groupId': 'OG003'}]}]}, {'title': 'Are you functioning as well as you were before?', 'categories': [{'measurements': [{'value': '12.6', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '0.36', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0360', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adults (\\>= 18 Years ) - Global Assessment: Have you felt as good as you did before you had the respiratory illness?', 'statisticalMethod': 'Fay - Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0380', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adults (\\>= 18 Years) - Global Assessment: Are you functioning as well as you were before you had the respiratory illness?', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5035', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'Children (\\< 18 Years) - Global Assessment: Have you/your child felt as good as you did before you had the respiratory illness?', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9231', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'Children (\\<18 Years) - Global Assessment: Are you/your child functioning as well as you/your child were before you/your child had the respiratory illness?', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured daily through Day 14 and on Day 28', 'description': '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.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antibiotics/Antivirals During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Antibiotic Use During First 5 Days of Hosp', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Antiviral Use During First 5 Days of Hosp', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Measured through participants' first 5 days of hospitalization", 'description': 'Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Are Re-hospitalized Within 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Adults >=18 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Children >18 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured through Day 28', 'description': 'Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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)'}, {'type': 'SECONDARY', 'title': 'Use of Systemic Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Subjects Taking Systemic Steroids - First 5 Days', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'DESMOPRESSIN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'DEXAMETHASONE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'GLUCOCORTICOIDS (Fluticasone/Vilanterol)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HYDROCORTISONE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'LEVOTHYROXINE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'LEVOTHYROXINE SODIUM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'METHYLPREDNISOLONE', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'NOVOTHYRAL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PREDNISONE', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured within First 5 Days', 'description': 'Number of study participants taking Systemic Steroids during first 5 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Intent to Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'No Detectable Virus on Day 3', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Same Detectable Virus on Day 3', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Different Detectable Virus on Day 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9785', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No Detectable Virus on Day 3', 'statisticalMethod': 'Fay-Shaw', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Day 3', 'description': 'Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis of Intent to Treat population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': 'Number of study participants with at least one Adverse Event During Study Duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': 'Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is based on the safety population.'}, {'type': 'SECONDARY', 'title': 'Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Creatinine (mg/dL): Day 3', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine (mg/dL): Day 7', 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine (mg/dL): Day 28', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin (mg/dL): Day 3', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin (mg/dL): Day 7', 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin (mg/dL): Day 28', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the Intent to Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'ALT (SGPT) (U/L): Day 3', 'categories': [{'measurements': [{'value': '32.7', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '27.2', 'groupId': 'OG001'}]}]}, {'title': 'ALT (SGPT) (U/L): Day 7', 'categories': [{'measurements': [{'value': '33.1', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '35.1', 'spread': '28.7', 'groupId': 'OG001'}]}]}, {'title': 'ALT (SGPT) (U/L): Day 28', 'categories': [{'measurements': [{'value': '26.7', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '16.8', 'groupId': 'OG001'}]}]}, {'title': 'AST (SGOT) (U/L): Day 3', 'categories': [{'measurements': [{'value': '32.7', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '30.4', 'groupId': 'OG001'}]}]}, {'title': 'AST (SGOT) (U/L): Day 7', 'categories': [{'measurements': [{'value': '33.2', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'AST (SGOT) (U/L): Day 28', 'categories': [{'measurements': [{'value': '33.0', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'LDH (U/L): Day 3', 'categories': [{'measurements': [{'value': '248.1', 'spread': '164.8', 'groupId': 'OG000'}, {'value': '266.8', 'spread': '180.0', 'groupId': 'OG001'}]}]}, {'title': 'LDH (U/L): Day 7', 'categories': [{'measurements': [{'value': '250.3', 'spread': '151.4', 'groupId': 'OG000'}, {'value': '255.2', 'spread': '150.8', 'groupId': 'OG001'}]}]}, {'title': 'LDH (U/L): Day 28', 'categories': [{'measurements': [{'value': '241.8', 'spread': '141.6', 'groupId': 'OG000'}, {'value': '249.7', 'spread': '151.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on Day 3, Day 7, and Day 28', 'description': 'Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the Intent to Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'CRP (mg/L): Day 3', 'categories': [{'measurements': [{'value': '2.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'CRP (mg/L): Day 7', 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'CRP (mg/L): Day 28', 'categories': [{'measurements': [{'value': '1.1', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the Intent to Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Neutrophils (%): Day 3', 'categories': [{'measurements': [{'value': '59.1', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '55.9', 'spread': '19.3', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (%): Day 7', 'categories': [{'measurements': [{'value': '52.4', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (%): Day 28', 'categories': [{'measurements': [{'value': '51.4', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '17.2', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (%): Day 3', 'categories': [{'measurements': [{'value': '31.6', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (%): Day 7', 'categories': [{'measurements': [{'value': '36.5', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (%): Day 28', 'categories': [{'measurements': [{'value': '36.1', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils (%): Day 3', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils (%): Day 7', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils (%): Day 28', 'categories': [{'measurements': [{'value': '3.8', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (%): Day 3', 'categories': [{'measurements': [{'value': '41.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (%): Day 7', 'categories': [{'measurements': [{'value': '40.7', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '40.9', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (%): Day 28', 'categories': [{'measurements': [{'value': '41.2', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.', 'unitOfMeasure': 'percentage of blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the Intent to Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'Hemoglobin (g/dL): Day 3', 'categories': [{'measurements': [{'value': '13.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (g/dL): Day 7', 'categories': [{'measurements': [{'value': '13.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (g/dL): Day 28', 'categories': [{'measurements': [{'value': '13.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the Intent to Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'classes': [{'title': 'WBC (10^3 cells/mcL): Day 3', 'categories': [{'measurements': [{'value': '9.0', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'WBC (10^3 cells/mcL): Day 7', 'categories': [{'measurements': [{'value': '9.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'WBC (10^3 cells/mcL): Day 28', 'categories': [{'measurements': [{'value': '8.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Platelets (10^3 cells/mcL): Day 3', 'categories': [{'measurements': [{'value': '301.3', 'spread': '123.5', 'groupId': 'OG000'}, {'value': '295.8', 'spread': '113.7', 'groupId': 'OG001'}]}]}, {'title': 'Platelets (10^3 cells/mcL): Day 7', 'categories': [{'measurements': [{'value': '364.7', 'spread': '155.9', 'groupId': 'OG000'}, {'value': '393.3', 'spread': '191.2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets (10^3 cells/mcL): Day 28', 'categories': [{'measurements': [{'value': '269.0', 'spread': '85.5', 'groupId': 'OG000'}, {'value': '267.5', 'spread': '110.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.', 'unitOfMeasure': '10^3 cells/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the Intent to Treat (ITT) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'Intent to Treat', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.\n\nNitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.\n\nPlacebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22.6', 'spread': '24.0', 'groupId': 'BG000'}, {'value': '23.6', 'spread': '24.4', 'groupId': 'BG001'}, {'value': '23.1', 'spread': '24.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.2', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '27.0', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The analysis only includes the adult (\\>= 18 years) population with evaluable data.'}, {'title': 'BMI Z Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '-0.6', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '-0.2', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Z-score indicates the number of standard deviations away from a reference population matched for age and gender. A Z-score of 0 is equal to the reference population. Negative numbers indicate BMI values lower than the reference population and positive numbers indicate values higher than the reference population.', 'unitOfMeasure': 'Z Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The analysis only included the child (\\< 18 years) population with evaluable data.'}], 'populationDescription': 'The analysis was based on the ITT population of 257 participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-17', 'size': 177720, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-24T14:05', 'hasProtocol': False}, {'date': '2016-09-12', 'size': 2128834, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-06T11:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2014-02-05', 'resultsFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2014-02-05', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-30', 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Hospital Discharge', 'timeFrame': 'Measured through Day 28', 'description': 'The time to hospital discharge measured through Day 28.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Hospitalized on Days 3, 7, 14, and 28', 'timeFrame': 'Measured at Day 3, Day 7, Day 14, and Day 28', 'description': 'The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.'}, {'measure': 'Number of Participants Who Died Within the First 5 Days', 'timeFrame': 'Measured within First 5 Days', 'description': 'Total Deaths of Participants, including Deaths within First 5 Days'}, {'measure': 'Number of Participants Who Experienced Clinical Symptoms', 'timeFrame': 'Measured through Day 28', 'description': 'Measured daily through Study Day 14 and then again on Study Day 28'}, {'measure': 'Duration of Fever in Study Participants', 'timeFrame': 'Measured each day through Day 14 and on Day 28', 'description': "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."}, {'measure': 'Number of Participants Who Require Oxygen Use', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': '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)'}, {'measure': '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)', 'timeFrame': "Measured through Day 28 or participants' last day in the ICU", 'description': '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.'}, {'measure': '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)', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': '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.'}, {'measure': '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', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': '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 .'}, {'measure': 'Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)', 'timeFrame': 'Measured daily through Day 14 and on Day 28', 'description': '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.'}, {'measure': 'Number of Participants Using Antibiotics/Antivirals During Hospitalization', 'timeFrame': "Measured through participants' first 5 days of hospitalization", 'description': 'Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.'}, {'measure': 'Number of Participants Who Are Re-hospitalized Within 28 Days', 'timeFrame': 'Measured through Day 28', 'description': 'Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).'}, {'measure': 'Use of Systemic Corticosteroids', 'timeFrame': 'Measured within First 5 Days', 'description': 'Number of study participants taking Systemic Steroids during first 5 days.'}, {'measure': 'Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)', 'timeFrame': 'Measured through Day 3', 'description': 'Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.'}, {'measure': 'Number of Participants Reporting Adverse Events (AEs)', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': 'Number of study participants with at least one Adverse Event During Study Duration'}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'timeFrame': "Measured through Day 28 or participants' last day of hospitalization", 'description': 'Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).'}, {'measure': 'Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.'}, {'measure': 'Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28', 'timeFrame': 'Measured on Day 3, Day 7, and Day 28', 'description': 'Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.'}, {'measure': 'Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.'}, {'measure': 'Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.'}, {'measure': 'Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.'}, {'measure': 'Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28', 'timeFrame': 'Measured on Day 3, Day, 7 and Day 28', 'description': 'Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Severe Acute Respiratory Illness']}, 'referencesModule': {'references': [{'pmid': '30753384', 'type': 'DERIVED', 'citation': 'Gamino-Arroyo AE, Guerrero ML, McCarthy S, Ramirez-Venegas A, Llamosas-Gallardo B, Galindo-Fraga A, Moreno-Espinosa S, Roldan-Aragon Y, Araujo-Melendez J, Hunsberger S, Ibarra-Gonzalez V, Martinez-Lopez J, Garcia-Andrade LA, Kapushoc H, Holley HP, Smolskis MC, Ruiz-Palacios GM, Beigel JH; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed). Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness. Clin Infect Dis. 2019 Nov 13;69(11):1903-1911. doi: 10.1093/cid/ciz100.'}]}, 'descriptionModule': {'briefSummary': 'Respiratory viruses are a significant cause of hospitalization for respiratory tract infections. This study will evaluate the safety, effectiveness, and tolerability of nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are hospitalized.', 'detailedDescription': "Respiratory viral infections are one of the most common causes of illness in the world. These infections are major causes of SARI and can lead to severe outcomes, including hospitalization and death. NTZ is a medication that is approved in the United States and Mexico to treat gastrointestinal parasitic diseases. This study will evaluate the use of NTZ to treat SARI. The purpose of this study is to evaluate the safety, effectiveness, and tolerability of NTZ, in combination with standard care, in treating SARI in people who are hospitalized.\n\nParticipants will be hospitalized and study entry assessments will include medical assessments, blood collection, and a nasopharyngeal swab or wash. Participants will then be randomly assigned to receive NTZ or placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ or placebo; participants 12 years and older will receive NTZ or placebo tablets. All participants will also receive standard of care treatment for acute severe viral respiratory infections, which may include antibiotics and/or treatment for influenza. They will be discharged from the hospital based on their doctors' recommendations. Participants will record their temperature and symptoms in a daily diary, which will be reviewed by study staff during study visits. Follow-up visits will occur on Days 3, 7, 14, and 28, and may occur as inpatient or outpatient visits. These visits may include the same assessments that occurred at baseline, as well as physical examinations, depending on the visit. Participants who are still hospitalized at Day 28 will be followed by study staff until they are discharged from the hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent prior to performance or initiation of any study procedures\n* Age greater than or equal to 12 months of age (no upper age limit)\n* Influenza-like illness (ILI), defined as (all of the following):\n\n * Onset of fever greater than or equal to 38°C (or hypothermia less than 36°C)\n * New or worse cough or sore throat\n * New or worse shortness of breath or difficulty breathing\n* Onset of illness no more than 5 days before screening defined as when the participant experienced at least 1 respiratory symptom, constitutional symptom, or fever\n* Hospitalization for ILI (decision for hospitalization will be up to the individual treating clinician), with anticipated hospitalization for more than 24 hours\n* One of the following to avoid pregnancy:\n\n * Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 1 effective form of contraception from the date of informed consent through Day 28 of study\n * Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms or have a partner use at least 1 effective form of contraception through Day 28 of study\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Clinical suspicion that etiology of illness is primarily bacterial in origin\n* Prior treatment with antivirals (e.g., oseltamivir) for the current illness for more than 24 hours\n* Unable to take oral medications (adults must tolerate tablets, children must tolerate suspension)\n* Unable to tolerate oral food/fluids (absorption is significantly better with food)\n* Prior treatment with any investigational drug therapy within 30 days prior to screening\n* Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets\n* Prior NTZ use within 1 week\n* Self-reported history of chronic kidney disease or impaired renal function (no blood or urine kidney function laboratory testing will be done prior to enrollment, but intent is to exclude disease severe enough to cause estimated creatinine clearance \\[CrCl\\] less than 30)\n* Self-reported history of liver disease (no blood laboratory testing will be done prior to enrollment, but intent is to exclude disease severe enough to cause cirrhosis or total bilirubin greater than 2, aspartate aminotransferase \\[AST\\]/alanine aminotransferase \\[ALT\\] greater than 3 times the upper limit of normal \\[ULN\\])\n* Presence of any pre-existing illness that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study\n* Participants who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol\n* The onset of SARI occurs after hospitalization\n* Hospitalized for any reason for greater than 48 hours prior to enrollment\n* Participants previously enrolled in this study\n* Prior hospital discharge within 30 days\n* Known chronic respiratory infection (e.g., tuberculosis, atypical mycobacterial infections)'}, 'identificationModule': {'nctId': 'NCT02057757', 'acronym': 'NTZ-SARI', 'briefTitle': 'Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Nitazoxanide Versus Placebo in Addition to Standard Care for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness', 'orgStudyIdInfo': {'id': 'NTZ-SARI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitazoxanide (NTZ)', 'description': 'Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.', 'interventionNames': ['Drug: Nitazoxanide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'otherNames': ['NTZ'], 'description': 'Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.\n\nParticipants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.', 'armGroupLabels': ['Nitazoxanide (NTZ)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PCB'], 'description': 'Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.\n\nParticipants 12 years and older: two placebo tablets orally twice daily for 5 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04530', 'city': 'Coyoacán', 'country': 'Mexico', 'facility': 'Instituto Nacional de Pediatria', 'geoPoint': {'lat': 19.3467, 'lon': -99.16174}}, {'zip': '68050', 'city': 'Oaxaca City', 'country': 'Mexico', 'facility': 'Hospital General Dr. Aurelio Valdivieso', 'geoPoint': {'lat': 17.06025, 'lon': -96.72544}}, {'zip': '78240', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Hospital Central Dr. Ignacio Morones Prieto', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '06720', 'city': 'Tamaulipas', 'country': 'Mexico', 'facility': 'Hospital Infantil de Mexico Federico Gomez', 'geoPoint': {'lat': 15.77189, 'lon': -93.40718}}, {'zip': '14000', 'city': 'Tlalpan', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias medicas y Nutricion Salvador Zubiran', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}, {'zip': '14000', 'city': 'Tlalpan', 'country': 'Mexico', 'facility': 'Instituto Nacional de Enfermedades Respiratorias', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}], 'overallOfficials': [{'name': 'Lourdes Guerrero Almeida, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, {'name': 'Ana Gamiño, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Infantil de Mexico Federico Gomez'}, {'name': 'Arturo Galindo Fraga, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, {'name': 'Sarbelio Moreno, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Infantil de Mexico Federico Gomez'}, {'name': 'Javier Araujo Melendez, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Central "Dr. Ignacio Morones Prieto"'}, {'name': 'Alejandra Ramirez Venegas, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Enfermedades Respiratorias'}, {'name': 'Beatriz Llamosas Gallardo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Pediatria'}, {'name': 'Yuri Roldan Aragon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Dr. Aurelio Valdivies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Mexican Emerging Infectious Diseases Clinical Research Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}