Trial Outcomes & Findings for Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness (NCT NCT02057757)
NCT ID: NCT02057757
Last Updated: 2018-08-01
Results Overview
The time to hospital discharge measured through Day 28.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Measured through Day 28
Results posted on
2018-08-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
129
|
|
Overall Study
Intent to Treat
|
130
|
127
|
|
Overall Study
COMPLETED
|
117
|
121
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
3
|
|
Overall Study
Non-compliance
|
1
|
0
|
Baseline Characteristics
The analysis only includes the adult (\>= 18 years) population with evaluable data.
Baseline characteristics by cohort
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
67 Participants
n=130 Participants
|
64 Participants
n=127 Participants
|
131 Participants
n=257 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=130 Participants
|
56 Participants
n=127 Participants
|
110 Participants
n=257 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=130 Participants
|
7 Participants
n=127 Participants
|
16 Participants
n=257 Participants
|
|
Age, Continuous
|
22.6 years
STANDARD_DEVIATION 24.0 • n=130 Participants
|
23.6 years
STANDARD_DEVIATION 24.4 • n=127 Participants
|
23.1 years
STANDARD_DEVIATION 24.2 • n=257 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=130 Participants
|
50 Participants
n=127 Participants
|
118 Participants
n=257 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=130 Participants
|
77 Participants
n=127 Participants
|
139 Participants
n=257 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
130 Participants
n=130 Participants
|
127 Participants
n=127 Participants
|
257 Participants
n=257 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=257 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=257 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=257 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=257 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=257 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=257 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=257 Participants
|
|
Race (NIH/OMB)
More than one race
|
129 Participants
n=130 Participants
|
127 Participants
n=127 Participants
|
256 Participants
n=257 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=257 Participants
|
|
Region of Enrollment
Mexico
|
130 participants
n=130 Participants
|
127 participants
n=127 Participants
|
257 participants
n=257 Participants
|
|
Body Mass Index (BMI)
|
27.2 kg/m^2
STANDARD_DEVIATION 6.2 • n=63 Participants • The analysis only includes the adult (\>= 18 years) population with evaluable data.
|
27.0 kg/m^2
STANDARD_DEVIATION 5.6 • n=62 Participants • The analysis only includes the adult (\>= 18 years) population with evaluable data.
|
27.1 kg/m^2
STANDARD_DEVIATION 5.9 • n=125 Participants • The analysis only includes the adult (\>= 18 years) population with evaluable data.
|
|
BMI Z Score
|
0.2 Z Score
STANDARD_DEVIATION 2.0 • n=66 Participants • The analysis only included the child (\< 18 years) population with evaluable data.
|
-0.6 Z Score
STANDARD_DEVIATION 2.5 • n=64 Participants • The analysis only included the child (\< 18 years) population with evaluable data.
|
-0.2 Z Score
STANDARD_DEVIATION 2.3 • n=130 Participants • The analysis only included the child (\< 18 years) population with evaluable data.
|
PRIMARY outcome
Timeframe: Measured through Day 28The time to hospital discharge measured through Day 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Time to Hospital Discharge
|
7.1 Days
Standard Error 0.37
|
7.5 Days
Standard Error 0.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Day 3, Day 7, Day 14, and Day 28Population: Number of study participants - adults (\>= 18 years) and children (\< 18 years) in the Intent-to-Treat population (ITT) hospitalized by time point
The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Hospitalized on Days 3, 7, 14, and 28
Day 3
|
95 participants
|
96 participants
|
—
|
—
|
|
Number of Participants Hospitalized on Days 3, 7, 14, and 28
Day 7
|
39 participants
|
38 participants
|
—
|
—
|
|
Number of Participants Hospitalized on Days 3, 7, 14, and 28
Day 14
|
7 participants
|
6 participants
|
—
|
—
|
|
Number of Participants Hospitalized on Days 3, 7, 14, and 28
Day 28
|
3 participants
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured within First 5 DaysPopulation: 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)
Total Deaths of Participants, including Deaths within First 5 Days
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Who Died Within the First 5 Days
Total Deaths
|
2 participants
|
1 participants
|
—
|
—
|
|
Number of Participants Who Died Within the First 5 Days
Deaths within the First 5 Days (Adults >=18) Years
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Died Within the First 5 Days
Deaths within the First 5 Days (Children<18) Years
|
0 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28Measured daily through Study Day 14 and then again on Study Day 28
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Clinical Symptoms
Cough
|
71 Participants
|
75 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Sore Throat
|
29 Participants
|
23 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Fatigue
|
60 Participants
|
54 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Nasal Discharge
|
40 Participants
|
25 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Difficulty Breathing
|
54 Participants
|
51 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Headache
|
21 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Muscle Pain
|
28 Participants
|
18 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Nausea
|
4 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Vomiting
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants Who Experienced Clinical Symptoms
Diarrhea
|
4 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured each day through Day 14 and on Day 28Study 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.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Duration of Fever in Study Participants
|
11.3 hours
Standard Error 3.55
|
20.6 hours
Standard Error 5.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28 or participants' last day of hospitalizationNumber 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)
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Who Require Oxygen Use
Any Time
|
119 Participants
|
118 Participants
|
—
|
—
|
|
Number of Participants Who Require Oxygen Use
Day 0
|
114 Participants
|
116 Participants
|
—
|
—
|
|
Number of Participants Who Require Oxygen Use
Day 3
|
74 Participants
|
80 Participants
|
—
|
—
|
|
Number of Participants Who Require Oxygen Use
Day 7
|
28 Participants
|
27 Participants
|
—
|
—
|
|
Number of Participants Who Require Oxygen Use
Day 14
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants Who Require Oxygen Use
Day 28
|
6 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28 or participants' last day in the ICUNumber 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.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
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)
Any Time
|
3 Participants
|
2 Participants
|
—
|
—
|
|
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)
Day 0
|
3 Participants
|
1 Participants
|
—
|
—
|
|
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)
Day 3
|
1 Participants
|
1 Participants
|
—
|
—
|
|
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)
Day 7
|
1 Participants
|
1 Participants
|
—
|
—
|
|
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)
Day 14
|
0 Participants
|
1 Participants
|
—
|
—
|
|
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)
Day 28
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28 or participants' last day of hospitalizationStudy 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.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
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)
Day 0
|
2 Participants
|
1 Participants
|
—
|
—
|
|
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)
Any Time
|
4 Participants
|
4 Participants
|
—
|
—
|
|
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)
Day 3
|
1 Participants
|
2 Participants
|
—
|
—
|
|
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)
Day 7
|
1 Participants
|
1 Participants
|
—
|
—
|
|
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)
Day 14
|
1 Participants
|
1 Participants
|
—
|
—
|
|
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)
Day 28
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28 or participants' last day of hospitalizationNumber 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 .
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
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
Pneumonia
|
74 Participants
|
73 Participants
|
—
|
—
|
|
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
Respiratory Failure Requiring Mechanical Vent.
|
0 Participants
|
0 Participants
|
—
|
—
|
|
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
Acute Respiratory Distress Syndrome (ARDS)
|
6 Participants
|
6 Participants
|
—
|
—
|
|
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
Sepsis
|
0 Participants
|
0 Participants
|
—
|
—
|
|
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
Bronchitis
|
2 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured daily through Day 14 and on Day 28Study 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.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=63 Participants
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.
|
Placebo
n=63 Participants
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.
|
Nitazoxanide (NTZ) - Children <18 Years
n=67 Participants
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.
|
Placebo - Children <18 Years
n=64 Participants
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.
|
|---|---|---|---|---|
|
Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)
Have you felt as good as you did before?
|
10.2 days
Standard Error 1.47
|
7.0 days
Standard Error 1.27
|
3.3 days
Standard Error 0.40
|
3.5 days
Standard Error 0.63
|
|
Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)
Are you functioning as well as you were before?
|
12.6 days
Standard Error 1.52
|
9.4 days
Standard Error 1.38
|
3.6 days
Standard Error 0.43
|
3.1 days
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Measured through participants' first 5 days of hospitalizationNumber of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Using Antibiotics/Antivirals During Hospitalization
Antibiotic Use During First 5 Days of Hosp
|
100 Participants
|
88 Participants
|
—
|
—
|
|
Number of Participants Using Antibiotics/Antivirals During Hospitalization
Antiviral Use During First 5 Days of Hosp
|
46 Participants
|
45 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28Population: 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)
Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Who Are Re-hospitalized Within 28 Days
Adults >=18 Years
|
1 participants
|
2 participants
|
—
|
—
|
|
Number of Participants Who Are Re-hospitalized Within 28 Days
Children >18 Years
|
1 participants
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured within First 5 DaysPopulation: The analysis was based on the Intent to Treat (ITT) population.
Number of study participants taking Systemic Steroids during first 5 days.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Use of Systemic Corticosteroids
DESMOPRESSIN
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
Subjects Taking Systemic Steroids - First 5 Days
|
78 Participants
|
70 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
DEXAMETHASONE
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
GLUCOCORTICOIDS (Fluticasone/Vilanterol)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
HYDROCORTISONE
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
LEVOTHYROXINE
|
6 Participants
|
8 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
LEVOTHYROXINE SODIUM
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
METHYLPREDNISOLONE
|
35 Participants
|
26 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
NOVOTHYRAL
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Use of Systemic Corticosteroids
PREDNISONE
|
43 Participants
|
35 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 3Population: Efficacy analysis of Intent to Treat population
Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=79 Participants
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.
|
Placebo
n=89 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)
No Detectable Virus on Day 3
|
17 Participants
|
19 Participants
|
—
|
—
|
|
Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)
Same Detectable Virus on Day 3
|
56 Participants
|
61 Participants
|
—
|
—
|
|
Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)
Different Detectable Virus on Day 3
|
6 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28 or participants' last day of hospitalizationPopulation: Analysis was based on the safety population.
Number of study participants with at least one Adverse Event During Study Duration
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)
|
83 Participants
|
80 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Day 28 or participants' last day of hospitalizationPopulation: The analysis is based on the safety population.
Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
6 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured on Day 3, Day, 7 and Day 28Population: This analysis was based on the Intent to Treat (ITT) population.
Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Creatinine (mg/dL): Day 3
|
0.5 mg/dL
Standard Deviation 0.3
|
0.6 mg/dL
Standard Deviation 0.4
|
—
|
—
|
|
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Creatinine (mg/dL): Day 7
|
1.1 mg/dL
Standard Deviation 5.3
|
0.6 mg/dL
Standard Deviation 0.3
|
—
|
—
|
|
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Creatinine (mg/dL): Day 28
|
0.6 mg/dL
Standard Deviation 1.1
|
0.6 mg/dL
Standard Deviation 0.4
|
—
|
—
|
|
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Total Bilirubin (mg/dL): Day 3
|
0.6 mg/dL
Standard Deviation 0.4
|
0.5 mg/dL
Standard Deviation 0.3
|
—
|
—
|
|
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Total Bilirubin (mg/dL): Day 7
|
1.0 mg/dL
Standard Deviation 4.6
|
0.5 mg/dL
Standard Deviation 0.3
|
—
|
—
|
|
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Total Bilirubin (mg/dL): Day 28
|
0.6 mg/dL
Standard Deviation 0.3
|
0.6 mg/dL
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured on Day 3, Day 7, and Day 28Population: This analysis was based on the Intent to Treat (ITT) population.
Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
ALT (SGPT) (U/L): Day 3
|
32.7 U/L
Standard Deviation 24.6
|
30.9 U/L
Standard Deviation 27.2
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
ALT (SGPT) (U/L): Day 7
|
33.1 U/L
Standard Deviation 20.5
|
35.1 U/L
Standard Deviation 28.7
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
ALT (SGPT) (U/L): Day 28
|
26.7 U/L
Standard Deviation 15.4
|
27.4 U/L
Standard Deviation 16.8
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
AST (SGOT) (U/L): Day 3
|
32.7 U/L
Standard Deviation 19.4
|
36.1 U/L
Standard Deviation 30.4
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
AST (SGOT) (U/L): Day 7
|
33.2 U/L
Standard Deviation 20.2
|
33.2 U/L
Standard Deviation 19.0
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
AST (SGOT) (U/L): Day 28
|
33.0 U/L
Standard Deviation 20.0
|
31.8 U/L
Standard Deviation 18.5
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
LDH (U/L): Day 3
|
248.1 U/L
Standard Deviation 164.8
|
266.8 U/L
Standard Deviation 180.0
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
LDH (U/L): Day 7
|
250.3 U/L
Standard Deviation 151.4
|
255.2 U/L
Standard Deviation 150.8
|
—
|
—
|
|
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
LDH (U/L): Day 28
|
241.8 U/L
Standard Deviation 141.6
|
249.7 U/L
Standard Deviation 151.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured on Day 3, Day, 7 and Day 28Population: This analysis was based on the Intent to Treat (ITT) population.
Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28
CRP (mg/L): Day 3
|
2.3 mg/L
Standard Deviation 4.1
|
2.2 mg/L
Standard Deviation 3.4
|
—
|
—
|
|
Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28
CRP (mg/L): Day 7
|
1.2 mg/L
Standard Deviation 3.3
|
1.1 mg/L
Standard Deviation 2.4
|
—
|
—
|
|
Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28
CRP (mg/L): Day 28
|
1.1 mg/L
Standard Deviation 3.7
|
0.5 mg/L
Standard Deviation 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured on Day 3, Day, 7 and Day 28Population: This analysis was based on the Intent to Treat (ITT) population.
Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Neutrophils (%): Day 3
|
59.1 percentage of blood
Standard Deviation 19.8
|
55.9 percentage of blood
Standard Deviation 19.3
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Neutrophils (%): Day 7
|
52.4 percentage of blood
Standard Deviation 21.0
|
52.3 percentage of blood
Standard Deviation 17.0
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Neutrophils (%): Day 28
|
51.4 percentage of blood
Standard Deviation 16.6
|
49.8 percentage of blood
Standard Deviation 17.2
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Lymphocytes (%): Day 3
|
31.6 percentage of blood
Standard Deviation 17.5
|
33.4 percentage of blood
Standard Deviation 17.0
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Lymphocytes (%): Day 7
|
36.5 percentage of blood
Standard Deviation 19.3
|
36.7 percentage of blood
Standard Deviation 16.0
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Lymphocytes (%): Day 28
|
36.1 percentage of blood
Standard Deviation 15.2
|
37.5 percentage of blood
Standard Deviation 16.9
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Eosinophils (%): Day 3
|
1.5 percentage of blood
Standard Deviation 2.2
|
2.3 percentage of blood
Standard Deviation 5.2
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Eosinophils (%): Day 7
|
2.3 percentage of blood
Standard Deviation 1.9
|
2.6 percentage of blood
Standard Deviation 2.7
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Eosinophils (%): Day 28
|
3.8 percentage of blood
Standard Deviation 4.3
|
3.6 percentage of blood
Standard Deviation 4.1
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Hematocrit (%): Day 3
|
41.3 percentage of blood
Standard Deviation 5.6
|
40.6 percentage of blood
Standard Deviation 6.1
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Hematocrit (%): Day 7
|
40.7 percentage of blood
Standard Deviation 5.3
|
40.9 percentage of blood
Standard Deviation 6.1
|
—
|
—
|
|
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Hematocrit (%): Day 28
|
41.2 percentage of blood
Standard Deviation 4.6
|
41.7 percentage of blood
Standard Deviation 6.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured on Day 3, Day, 7 and Day 28Population: This analysis was based on the Intent to Treat (ITT) population.
Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28
Hemoglobin (g/dL): Day 3
|
13.5 g/dL
Standard Deviation 1.8
|
13.2 g/dL
Standard Deviation 2.0
|
—
|
—
|
|
Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28
Hemoglobin (g/dL): Day 7
|
13.5 g/dL
Standard Deviation 1.7
|
13.4 g/dL
Standard Deviation 2.1
|
—
|
—
|
|
Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28
Hemoglobin (g/dL): Day 28
|
13.6 g/dL
Standard Deviation 1.5
|
13.6 g/dL
Standard Deviation 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured on Day 3, Day, 7 and Day 28Population: This analysis was based on the Intent to Treat (ITT) population.
Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.
Outcome measures
| Measure |
Nitazoxanide (NTZ)
n=130 Participants
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.
|
Placebo
n=127 Participants
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.
|
Nitazoxanide (NTZ) - Children <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.
|
Placebo - Children <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.
|
|---|---|---|---|---|
|
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
WBC (10^3 cells/mcL): Day 3
|
9.0 10^3 cells/mcL
Standard Deviation 3.9
|
8.2 10^3 cells/mcL
Standard Deviation 3.4
|
—
|
—
|
|
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
WBC (10^3 cells/mcL): Day 7
|
9.8 10^3 cells/mcL
Standard Deviation 3.9
|
9.1 10^3 cells/mcL
Standard Deviation 3.8
|
—
|
—
|
|
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
WBC (10^3 cells/mcL): Day 28
|
8.1 10^3 cells/mcL
Standard Deviation 3.1
|
8.2 10^3 cells/mcL
Standard Deviation 3.3
|
—
|
—
|
|
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
Platelets (10^3 cells/mcL): Day 3
|
301.3 10^3 cells/mcL
Standard Deviation 123.5
|
295.8 10^3 cells/mcL
Standard Deviation 113.7
|
—
|
—
|
|
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
Platelets (10^3 cells/mcL): Day 7
|
364.7 10^3 cells/mcL
Standard Deviation 155.9
|
393.3 10^3 cells/mcL
Standard Deviation 191.2
|
—
|
—
|
|
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
Platelets (10^3 cells/mcL): Day 28
|
269.0 10^3 cells/mcL
Standard Deviation 85.5
|
267.5 10^3 cells/mcL
Standard Deviation 110.9
|
—
|
—
|
Adverse Events
Nitazoxanide (NTZ)
Serious events: 6 serious events
Other events: 26 other events
Deaths: 2 deaths
Placebo
Serious events: 3 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nitazoxanide (NTZ)
n=130 participants at risk
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.
|
Placebo
n=127 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/130 • 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).
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)
|
0.79%
1/127 • Number of events 1 • 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).
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)
|
|
Infections and infestations
Aspergillosis
|
0.77%
1/130 • Number of events 1 • 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).
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)
|
0.00%
0/127 • 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).
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)
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130 • Number of events 1 • 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).
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)
|
1.6%
2/127 • Number of events 2 • 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).
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)
|
|
Infections and infestations
Pneumonia Viral
|
0.77%
1/130 • Number of events 1 • 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).
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)
|
0.00%
0/127 • 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).
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)
|
|
Infections and infestations
Septic Shock
|
0.77%
1/130 • Number of events 1 • 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).
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)
|
0.79%
1/127 • Number of events 1 • 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).
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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Immune Reconstitution Inflammatory Syndrome Associated Kaposi's Sarcoma
|
0.00%
0/130 • 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).
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)
|
0.79%
1/127 • Number of events 1 • 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).
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)
|
|
Psychiatric disorders
Delirium
|
0.77%
1/130 • Number of events 1 • 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).
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)
|
0.00%
0/127 • 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).
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)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.5%
2/130 • Number of events 2 • 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).
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)
|
0.79%
1/127 • Number of events 1 • 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).
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)
|
Other adverse events
| Measure |
Nitazoxanide (NTZ)
n=130 participants at risk
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.
|
Placebo
n=127 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Vomitting
|
6.2%
8/130 • Number of events 9 • 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).
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)
|
11.0%
14/127 • Number of events 14 • 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).
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)
|
|
General disorders
Pyrexia
|
6.2%
8/130 • Number of events 8 • 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).
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)
|
3.9%
5/127 • Number of events 5 • 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).
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)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
10/130 • Number of events 10 • 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).
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)
|
5.5%
7/127 • Number of events 7 • 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).
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)
|
Additional Information
Dr. John Beigel
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-451-9881
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place