Nitazoxanide Versus Placebo for the Treatment of Hospital... | NCT02057757

NCT02057757

Status Module

Sponsor/Collaborators Module

Name	Class
Mexican Emerging Infectious Diseases Clinical Research Network	NETWORK

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nitazoxanide (NTZ)	Experimental	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.	Drug: Nitazoxanide
Placebo	Placebo Comparator	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.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitazoxanide	Drug	Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.

Outcomes Module

Measure	Description	Time Frame
Time to Hospital Discharge	The time to hospital discharge measured through Day 28.	Measured through Day 28

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Hospitalized on Days 3, 7, 14, and 28	The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.	Measured at Day 3, Day 7, Day 14, and Day 28
Number of Participants Who Died Within the First 5 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent prior to performance or initiation of any study procedures
Age greater than or equal to 12 months of age (no upper age limit)
Influenza-like illness (ILI), defined as (all of the following):
- Onset of fever greater than or equal to 38°C (or hypothermia less than 36°C)
- New or worse cough or sore throat
- New or worse shortness of breath or difficulty breathing
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
Hospitalization for ILI (decision for hospitalization will be up to the individual treating clinician), with anticipated hospitalization for more than 24 hours
One of the following to avoid pregnancy:
- 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
- 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

Exclusion Criteria:

Women who are pregnant or breastfeeding
Clinical suspicion that etiology of illness is primarily bacterial in origin
Prior treatment with antivirals (e.g., oseltamivir) for the current illness for more than 24 hours
Unable to take oral medications (adults must tolerate tablets, children must tolerate suspension)
Unable to tolerate oral food/fluids (absorption is significantly better with food)
Prior treatment with any investigational drug therapy within 30 days prior to screening
Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets
Prior NTZ use within 1 week
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)
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])
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
Participants who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
The onset of SARI occurs after hospitalization
Hospitalized for any reason for greater than 48 hours prior to enrollment
Participants previously enrolled in this study
Prior hospital discharge within 30 days
Known chronic respiratory infection (e.g., tuberculosis, atypical mycobacterial infections)

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Lourdes Guerrero Almeida, M.D.	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Study Chair
Ana Gamiño, M.D.	Hospital Infantil de Mexico Federico Gomez	Study Chair
Arturo Galindo Fraga, M.D.	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Principal Investigator
Sarbelio Moreno, M.D.	Hospital Infantil de Mexico Federico Gomez	Principal Investigator
Javier Araujo Melendez, M.D.	Hospital Central "Dr. Ignacio Morones Prieto"	Principal Investigator
Alejandra Ramirez Venegas, M.D.	Instituto Nacional de Enfermedades Respiratorias	Principal Investigator
Beatriz Llamosas Gallardo, M.D.	Instituto Nacional de Pediatria	Principal Investigator
Yuri Roldan Aragon, M.D.	Hospital General Dr. Aurelio Valdivies	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Pediatria		Coyoacán		04530	Mexico
Hospital General Dr. Aurelio Valdivieso

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30753384	Derived	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Oct 17, 2017	May 24, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

The analysis was based on the ITT population of 257 participants.

Arm/Group Information

ID	Title	Description
BG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
BG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG0007.1± 0.37 OG0017.5± 0.41

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fay - Shaw		0.5634														Equivalence	The equivalence margin is 1.25 Days.

Secondary

Number of Participants Hospitalized on Days 3, 7, 14, and 28

The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.

Number of study participants - adults (>= 18 years) and children (< 18 years) in the Intent-to-Treat population (ITT) hospitalized by time point

Posted

Number

participants

Measured at Day 3, Day 7, Day 14, and Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Participants Who Died Within the First 5 Days

Total Deaths of Participants, including Deaths within First 5 Days

The Adult (>=18 Years) population includes 126 participants (63 in NTZ arm; 63 in Placebo arm). The Children (<18 Years) population includes 131 participants (67 in NTZ arm; 64 in Placebo arm)

Posted

Number

participants

Measured within First 5 Days

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Participants Who Experienced Clinical Symptoms

Measured daily through Study Day 14 and then again on Study Day 28

Posted

Count of Participants

Participants

Measured through Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Units	Counts

Secondary

Duration of Fever in Study Participants

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.

Posted

Mean

Standard Error

hours

Measured each day through Day 14 and on Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Participants Who Require Oxygen Use

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)

Posted

Count of Participants

Participants

Measured through Day 28 or participants' last day of hospitalization

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28)

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.

Posted

Count of Participants

Participants

Measured through Day 28 or participants' last day in the ICU

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28)

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.

Posted

Count of Participants

Participants

Measured through Day 28 or participants' last day of hospitalization

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study

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 .

Posted

Count of Participants

Participants

Measured through Day 28 or participants' last day of hospitalization

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)

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.

Posted

Mean

Standard Error

days

Measured daily through Day 14 and on Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ) - Adults >=18 Years	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo - Adults >=18 Years	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.
OG002

Secondary

Number of Participants Using Antibiotics/Antivirals During Hospitalization

Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.

Posted

Count of Participants

Participants

Measured through participants' first 5 days of hospitalization

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Participants Who Are Re-hospitalized Within 28 Days

Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).

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)

Posted

Number

participants

Measured through Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Use of Systemic Corticosteroids

Number of study participants taking Systemic Steroids during first 5 days.

The analysis was based on the Intent to Treat (ITT) population.

Posted

Count of Participants

Participants

Measured within First 5 Days

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)

Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.

Efficacy analysis of Intent to Treat population

Posted

Count of Participants

Participants

Measured through Day 3

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Participants Reporting Adverse Events (AEs)

Number of study participants with at least one Adverse Event During Study Duration

Analysis was based on the safety population.

Posted

Count of Participants

Participants

Measured through Day 28 or participants' last day of hospitalization

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Number of Participants Reporting Serious Adverse Events (SAEs)

Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).

The analysis is based on the safety population.

Posted

Count of Participants

Participants

Measured through Day 28 or participants' last day of hospitalization

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28

Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.

This analysis was based on the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

mg/dL

Measured on Day 3, Day, 7 and Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28

Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.

This analysis was based on the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

U/L

Measured on Day 3, Day 7, and Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28

Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.

This analysis was based on the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

mg/L

Measured on Day 3, Day, 7 and Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28

Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.

This analysis was based on the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

percentage of blood

Measured on Day 3, Day, 7 and Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28

Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.

This analysis was based on the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

g/dL

Measured on Day 3, Day, 7 and Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Secondary

Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28

Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.

This analysis was based on the Intent to Treat (ITT) population.

Posted

Mean

Standard Deviation

10^3 cells/mcL

Measured on Day 3, Day, 7 and Day 28

ID	Title	Description
OG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
OG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nitazoxanide (NTZ)	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. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.	2	130	6	130	26	130
EG001	Placebo	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. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.	1	127	3	127	26	127

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected127 at risk
Aspergillosis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected130 at risk EG0010 events0 affected127 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected130 at risk EG0012 events2 affected127 at risk
Pneumonia Viral	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected130 at risk EG0010 events0 affected127 at risk
Septic Shock	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected130 at risk EG0011 events1 affected127 at risk
Immune Reconstitution Inflammatory Syndrome Associated Kaposi's Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected130 at risk EG0011 events1 affected127 at risk
Delirium	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected130 at risk EG0010 events0 affected127 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected130 at risk EG0011 events1 affected127 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vomitting	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	MedDRA System Organ Class and Preferred term.	EG0009 events8 affected130 at risk EG00114 events14 affected127 at risk
Pyrexia	General disorders	MedDRA (16.1)	Systematic Assessment	MedDRA System Organ Class and Preferred Term.	EG0008 events8 affected130 at risk EG0015 events5 affected127 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	MedDRA System Organ Class and Preferred Term.	EG00010 events10 affected130 at risk EG0017 events7 affected127 at risk

There were no significant limitations of the study.

Certain Agreements

ID	Term
C041747	nitazoxanide

ParticipantsBG002130

Units	Counts
Participants	OG000130 OG001127

Units	Counts
Participants	OG00079 OG00189

Units	Counts
Participants	OG000130 OG001127

Units	Counts
Participants	OG000130 OG001127

Units	Counts
Participants	OG000130 OG001127

Units	Counts
Participants	OG000130 OG001127

Units	Counts
Participants	OG000130 OG001127

Units	Counts
Participants	OG000130 OG001127

Units	Counts
Participants	OG000130 OG001127