Severe Acute Respiratory Illness
Conditions
Brief summary
Respiratory viruses are a significant cause of hospitalization for respiratory tract infections. This study will evaluate the safety, effectiveness, and tolerability of nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are hospitalized.
Detailed description
Respiratory viral infections are one of the most common causes of illness in the world. These infections are major causes of SARI and can lead to severe outcomes, including hospitalization and death. NTZ is a medication that is approved in the United States and Mexico to treat gastrointestinal parasitic diseases. This study will evaluate the use of NTZ to treat SARI. The purpose of this study is to evaluate the safety, effectiveness, and tolerability of NTZ, in combination with standard care, in treating SARI in people who are hospitalized. Participants will be hospitalized and study entry assessments will include medical assessments, blood collection, and a nasopharyngeal swab or wash. Participants will then be randomly assigned to receive NTZ or placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ or placebo; participants 12 years and older will receive NTZ or placebo tablets. All participants will also receive standard of care treatment for acute severe viral respiratory infections, which may include antibiotics and/or treatment for influenza. They will be discharged from the hospital based on their doctors' recommendations. Participants will record their temperature and symptoms in a daily diary, which will be reviewed by study staff during study visits. Follow-up visits will occur on Days 3, 7, 14, and 28, and may occur as inpatient or outpatient visits. These visits may include the same assessments that occurred at baseline, as well as physical examinations, depending on the visit. Participants who are still hospitalized at Day 28 will be followed by study staff until they are discharged from the hospital.
Interventions
DRUGNitazoxanide
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.
DRUGPlacebo
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.
Sponsors
Mexican Emerging Infectious Diseases Clinical Research Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent prior to performance or initiation of any study procedures * Age greater than or equal to 12 months of age (no upper age limit) * Influenza-like illness (ILI), defined as (all of the following): * Onset of fever greater than or equal to 38°C (or hypothermia less than 36°C) * New or worse cough or sore throat * New or worse shortness of breath or difficulty breathing * Onset of illness no more than 5 days before screening defined as when the participant experienced at least 1 respiratory symptom, constitutional symptom, or fever * Hospitalization for ILI (decision for hospitalization will be up to the individual treating clinician), with anticipated hospitalization for more than 24 hours * One of the following to avoid pregnancy: * Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 1 effective form of contraception from the date of informed consent through Day 28 of study * Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms or have a partner use at least 1 effective form of contraception through Day 28 of study
Exclusion criteria
* Women who are pregnant or breastfeeding * Clinical suspicion that etiology of illness is primarily bacterial in origin * Prior treatment with antivirals (e.g., oseltamivir) for the current illness for more than 24 hours * Unable to take oral medications (adults must tolerate tablets, children must tolerate suspension) * Unable to tolerate oral food/fluids (absorption is significantly better with food) * Prior treatment with any investigational drug therapy within 30 days prior to screening * Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets * Prior NTZ use within 1 week * Self-reported history of chronic kidney disease or impaired renal function (no blood or urine kidney function laboratory testing will be done prior to enrollment, but intent is to exclude disease severe enough to cause estimated creatinine clearance \[CrCl\] less than 30) * Self-reported history of liver disease (no blood laboratory testing will be done prior to enrollment, but intent is to exclude disease severe enough to cause cirrhosis or total bilirubin greater than 2, aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\] greater than 3 times the upper limit of normal \[ULN\]) * Presence of any pre-existing illness that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study * Participants who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol * The onset of SARI occurs after hospitalization * Hospitalized for any reason for greater than 48 hours prior to enrollment * Participants previously enrolled in this study * Prior hospital discharge within 30 days * Known chronic respiratory infection (e.g., tuberculosis, atypical mycobacterial infections)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hospital Discharge | Measured through Day 28 | The time to hospital discharge measured through Day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died Within the First 5 Days | Measured within First 5 Days | Total Deaths of Participants, including Deaths within First 5 Days |
| Number of Participants Who Experienced Clinical Symptoms | Measured through Day 28 | Measured daily through Study Day 14 and then again on Study Day 28 |
| Duration of Fever in Study Participants | Measured each day through Day 14 and on Day 28 | Study participants' duration (hours) of fever measured daily through Day 14 and then again on Day 28. The total duration in hours from the visit when fever was registered for the study participant until the next visit when no fever was registered for the study participant. |
| Number of Participants Who Require Oxygen Use | Measured through Day 28 or participants' last day of hospitalization | Number of study participants who require use of supplemental oxygen at time points (e.g., Any time, Day 0, Day 3, Day 7, Day 14, and Day 28) |
| Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28) | Measured through Day 28 or participants' last day in the ICU | Number of study participants (e.g., adult and children) admitted to the intensive care unit (ICU) by time point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed. |
| Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28) | Measured through Day 28 or participants' last day of hospitalization | Study participants (e.g., adults, children) requiring mechanical ventilation (e.g., intubation/extubation) at study time points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed. |
| Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study | Measured through Day 28 or participants' last day of hospitalization | Number of study participants (e.g., adults and children) with the presence of a complication (pneumonia, respiratory failure requiring mechanical ventilation, acute respiratory distress syndrome \[ARDS\], sepsis, or bronchiolitis) during the study . |
| Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children) | Measured daily through Day 14 and on Day 28 | Study participant (e.g., adults and children) answers (e.g., yes) to global assessment questions measured daily through Day 14 and then again on Day 28. |
| Number of Participants Using Antibiotics/Antivirals During Hospitalization | Measured through participants' first 5 days of hospitalization | Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization. |
| Number of Participants Who Are Re-hospitalized Within 28 Days | Measured through Day 28 | Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization). |
| Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Measured at Day 3, Day 7, Day 14, and Day 28 | The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28. |
| Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0) | Measured through Day 3 | Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3. |
| Number of Participants Reporting Adverse Events (AEs) | Measured through Day 28 or participants' last day of hospitalization | Number of study participants with at least one Adverse Event During Study Duration |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through Day 28 or participants' last day of hospitalization | Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs). |
| Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28 | Measured on Day 3, Day, 7 and Day 28 | Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28. |
| Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | Measured on Day 3, Day 7, and Day 28 | Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28. |
| Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28 | Measured on Day 3, Day, 7 and Day 28 | Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28. |
| Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Measured on Day 3, Day, 7 and Day 28 | Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28. |
| Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28 | Measured on Day 3, Day, 7 and Day 28 | Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28. |
| Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28 | Measured on Day 3, Day, 7 and Day 28 | Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28. |
| Use of Systemic Corticosteroids | Measured within First 5 Days | Number of study participants taking Systemic Steroids during first 5 days. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 130 |
| 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. | 127 |
| Total | 257 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 8 | 3 |
| Overall Study | Non-compliance | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Nitazoxanide (NTZ) | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 67 Participants | 64 Participants | 131 Participants |
| Age, Categorical >=65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 56 Participants | 110 Participants |
| Age, Continuous | 22.6 years STANDARD_DEVIATION 24 | 23.6 years STANDARD_DEVIATION 24.4 | 23.1 years STANDARD_DEVIATION 24.2 |
| BMI Z Score | 0.2 Z Score STANDARD_DEVIATION 2 | -0.6 Z Score STANDARD_DEVIATION 2.5 | -0.2 Z Score STANDARD_DEVIATION 2.3 |
| Body Mass Index (BMI) | 27.2 kg/m^2 STANDARD_DEVIATION 6.2 | 27.0 kg/m^2 STANDARD_DEVIATION 5.6 | 27.1 kg/m^2 STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 130 Participants | 127 Participants | 257 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 129 Participants | 127 Participants | 256 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Mexico | 130 participants | 127 participants | 257 participants |
| Sex: Female, Male Female | 68 Participants | 50 Participants | 118 Participants |
| Sex: Female, Male Male | 62 Participants | 77 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 130 | 1 / 127 |
| other Total, other adverse events | 26 / 130 | 26 / 127 |
| serious Total, serious adverse events | 6 / 130 | 3 / 127 |
Outcome results
Primary
Time to Hospital Discharge
The time to hospital discharge measured through Day 28.
Time frame: Measured through Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitazoxanide (NTZ) | Time to Hospital Discharge | 7.1 Days | Standard Error 0.37 |
| Placebo | Time to Hospital Discharge | 7.5 Days | Standard Error 0.41 |
p-value: 0.5634Fay - Shaw
Secondary
Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28
Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.
Time frame: Measured on Day 3, Day, 7 and Day 28
Population: This analysis was based on the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nitazoxanide (NTZ) | Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28 | CRP (mg/L): Day 3 | 2.3 mg/L | Standard Deviation 4.1 |
| Nitazoxanide (NTZ) | Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28 | CRP (mg/L): Day 7 | 1.2 mg/L | Standard Deviation 3.3 |
| Nitazoxanide (NTZ) | Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28 | CRP (mg/L): Day 28 | 1.1 mg/L | Standard Deviation 3.7 |
| Placebo | Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28 | CRP (mg/L): Day 3 | 2.2 mg/L | Standard Deviation 3.4 |
| Placebo | Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28 | CRP (mg/L): Day 7 | 1.1 mg/L | Standard Deviation 2.4 |
| Placebo | Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28 | CRP (mg/L): Day 28 | 0.5 mg/L | Standard Deviation 0.7 |
Secondary
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.
Time frame: Measured on Day 3, Day 7, and Day 28
Population: This analysis was based on the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | LDH (U/L): Day 28 | 249.7 U/L | Standard Deviation 151.3 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | ALT (SGPT) (U/L): Day 3 | 30.9 U/L | Standard Deviation 27.2 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | ALT (SGPT) (U/L): Day 7 | 35.1 U/L | Standard Deviation 28.7 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | ALT (SGPT) (U/L): Day 28 | 27.4 U/L | Standard Deviation 16.8 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | AST (SGOT) (U/L): Day 3 | 36.1 U/L | Standard Deviation 30.4 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | AST (SGOT) (U/L): Day 7 | 33.2 U/L | Standard Deviation 19 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | AST (SGOT) (U/L): Day 28 | 31.8 U/L | Standard Deviation 18.5 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | LDH (U/L): Day 3 | 266.8 U/L | Standard Deviation 180 |
| Placebo | Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28 | LDH (U/L): Day 7 | 255.2 U/L | Standard Deviation 150.8 |
Secondary
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.
Time frame: Measured on Day 3, Day, 7 and Day 28
Population: This analysis was based on the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28 | Total Bilirubin (mg/dL): Day 7 | 0.5 mg/dL | Standard Deviation 0.3 |
| Placebo | Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28 | Creatinine (mg/dL): Day 3 | 0.6 mg/dL | Standard Deviation 0.4 |
| Placebo | Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28 | Total Bilirubin (mg/dL): Day 3 | 0.5 mg/dL | Standard Deviation 0.3 |
| Placebo | Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28 | Creatinine (mg/dL): Day 7 | 0.6 mg/dL | Standard Deviation 0.3 |
| Placebo | 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 |
| Placebo | Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28 | Creatinine (mg/dL): Day 28 | 0.6 mg/dL | Standard Deviation 0.4 |
Secondary
Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)
Study participant (e.g., adults and children) answers (e.g., yes) to global assessment questions measured daily through Day 14 and then again on Day 28.
Time frame: Measured daily through Day 14 and on Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | 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? | 9.4 days | Standard Error 1.38 |
| Placebo | 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? | 7.0 days | Standard Error 1.27 |
| Nitazoxanide (NTZ) - Children <18 Years | 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? | 3.3 days | Standard Error 0.4 |
| Nitazoxanide (NTZ) - Children <18 Years | 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? | 3.6 days | Standard Error 0.43 |
| Placebo - Children <18 Years | 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? | 3.5 days | Standard Error 0.63 |
| Placebo - Children <18 Years | 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? | 3.1 days | Standard Error 0.36 |
p-value: 0.036Fay - Shaw
p-value: 0.038Fay-Shaw
p-value: 0.5035Fay-Shaw
p-value: 0.9231Fay-Shaw
Secondary
Duration of Fever in Study Participants
Study participants' duration (hours) of fever measured daily through Day 14 and then again on Day 28. The total duration in hours from the visit when fever was registered for the study participant until the next visit when no fever was registered for the study participant.
Time frame: Measured each day through Day 14 and on Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitazoxanide (NTZ) | Duration of Fever in Study Participants | 11.3 hours | Standard Error 3.55 |
| Placebo | Duration of Fever in Study Participants | 20.6 hours | Standard Error 5.44 |
p-value: 0.985Fay - Shaw
Secondary
Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28
Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.
Time frame: Measured on Day 3, Day, 7 and Day 28
Population: This analysis was based on the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nitazoxanide (NTZ) | Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28 | Hemoglobin (g/dL): Day 3 | 13.5 g/dL | Standard Deviation 1.8 |
| Nitazoxanide (NTZ) | Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28 | Hemoglobin (g/dL): Day 7 | 13.5 g/dL | Standard Deviation 1.7 |
| Nitazoxanide (NTZ) | Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28 | Hemoglobin (g/dL): Day 28 | 13.6 g/dL | Standard Deviation 1.5 |
| Placebo | Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28 | Hemoglobin (g/dL): Day 28 | 13.6 g/dL | Standard Deviation 2 |
| Placebo | Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28 | Hemoglobin (g/dL): Day 3 | 13.2 g/dL | Standard Deviation 2 |
| Placebo | Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28 | Hemoglobin (g/dL): Day 7 | 13.4 g/dL | Standard Deviation 2.1 |
Secondary
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.
Time frame: Measured on Day 3, Day, 7 and Day 28
Population: This analysis was based on the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Hematocrit (%): Day 7 | 40.9 percentage of blood | Standard Deviation 6.1 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Neutrophils (%): Day 3 | 55.9 percentage of blood | Standard Deviation 19.3 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Eosinophils (%): Day 3 | 2.3 percentage of blood | Standard Deviation 5.2 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Neutrophils (%): Day 7 | 52.3 percentage of blood | Standard Deviation 17 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Hematocrit (%): Day 3 | 40.6 percentage of blood | Standard Deviation 6.1 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Neutrophils (%): Day 28 | 49.8 percentage of blood | Standard Deviation 17.2 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Eosinophils (%): Day 7 | 2.6 percentage of blood | Standard Deviation 2.7 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Lymphocytes (%): Day 3 | 33.4 percentage of blood | Standard Deviation 17 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Hematocrit (%): Day 28 | 41.7 percentage of blood | Standard Deviation 6.1 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Lymphocytes (%): Day 7 | 36.7 percentage of blood | Standard Deviation 16 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Eosinophils (%): Day 28 | 3.6 percentage of blood | Standard Deviation 4.1 |
| Placebo | Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28 | Lymphocytes (%): Day 28 | 37.5 percentage of blood | Standard Deviation 16.9 |
Secondary
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.
Time frame: Measured on Day 3, Day, 7 and Day 28
Population: This analysis was based on the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28 | Platelets (10^3 cells/mcL): Day 28 | 267.5 10^3 cells/mcL | Standard Deviation 110.9 |
| Placebo | Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28 | WBC (10^3 cells/mcL): Day 3 | 8.2 10^3 cells/mcL | Standard Deviation 3.4 |
| Placebo | Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28 | WBC (10^3 cells/mcL): Day 7 | 9.1 10^3 cells/mcL | Standard Deviation 3.8 |
| Placebo | Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28 | WBC (10^3 cells/mcL): Day 28 | 8.2 10^3 cells/mcL | Standard Deviation 3.3 |
| Placebo | Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28 | Platelets (10^3 cells/mcL): Day 7 | 393.3 10^3 cells/mcL | Standard Deviation 191.2 |
| Placebo | Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28 | Platelets (10^3 cells/mcL): Day 3 | 295.8 10^3 cells/mcL | Standard Deviation 113.7 |
Secondary
Number of Participants Hospitalized on Days 3, 7, 14, and 28
The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.
Time frame: Measured at Day 3, Day 7, Day 14, and Day 28
Population: Number of study participants - adults (\>= 18 years) and children (\< 18 years) in the Intent-to-Treat population (ITT) hospitalized by time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 3 | 95 participants |
| Nitazoxanide (NTZ) | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 7 | 39 participants |
| Nitazoxanide (NTZ) | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 14 | 7 participants |
| Nitazoxanide (NTZ) | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 28 | 3 participants |
| Placebo | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 28 | 2 participants |
| Placebo | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 3 | 96 participants |
| Placebo | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 14 | 6 participants |
| Placebo | Number of Participants Hospitalized on Days 3, 7, 14, and 28 | Day 7 | 38 participants |
p-value: 0.645Fay - Shaw
p-value: 0.989Fay-Shaw
p-value: 0.809Fay-Shaw
p-value: 0.671Fay-Shaw
Secondary
Number of Participants Reporting Adverse Events (AEs)
Number of study participants with at least one Adverse Event During Study Duration
Time frame: Measured through Day 28 or participants' last day of hospitalization
Population: Analysis was based on the safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Reporting Adverse Events (AEs) | 83 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs) | 80 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAEs)
Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).
Time frame: Measured through Day 28 or participants' last day of hospitalization
Population: The analysis is based on the safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Reporting Serious Adverse Events (SAEs) | 6 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Number of Participants Using Antibiotics/Antivirals During Hospitalization
Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.
Time frame: Measured through participants' first 5 days of hospitalization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Using Antibiotics/Antivirals During Hospitalization | Antibiotic Use During First 5 Days of Hosp | 100 Participants |
| Nitazoxanide (NTZ) | Number of Participants Using Antibiotics/Antivirals During Hospitalization | Antiviral Use During First 5 Days of Hosp | 46 Participants |
| Placebo | Number of Participants Using Antibiotics/Antivirals During Hospitalization | Antibiotic Use During First 5 Days of Hosp | 88 Participants |
| Placebo | Number of Participants Using Antibiotics/Antivirals During Hospitalization | Antiviral Use During First 5 Days of Hosp | 45 Participants |
Secondary
Number of Participants Who Are Re-hospitalized Within 28 Days
Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).
Time frame: Measured through Day 28
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Who Are Re-hospitalized Within 28 Days | Adults >=18 Years | 1 participants |
| Nitazoxanide (NTZ) | Number of Participants Who Are Re-hospitalized Within 28 Days | Children >18 Years | 1 participants |
| Placebo | Number of Participants Who Are Re-hospitalized Within 28 Days | Adults >=18 Years | 2 participants |
| Placebo | Number of Participants Who Are Re-hospitalized Within 28 Days | Children >18 Years | 2 participants |
Secondary
Number of Participants Who Died Within the First 5 Days
Total Deaths of Participants, including Deaths within First 5 Days
Time frame: Measured within First 5 Days
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Who Died Within the First 5 Days | Total Deaths | 2 participants |
| Nitazoxanide (NTZ) | Number of Participants Who Died Within the First 5 Days | Deaths within the First 5 Days (Adults >=18) Years | 0 participants |
| Nitazoxanide (NTZ) | Number of Participants Who Died Within the First 5 Days | Deaths within the First 5 Days (Children<18) Years | 0 participants |
| Placebo | Number of Participants Who Died Within the First 5 Days | Total Deaths | 1 participants |
| Placebo | Number of Participants Who Died Within the First 5 Days | Deaths within the First 5 Days (Adults >=18) Years | 0 participants |
| Placebo | Number of Participants Who Died Within the First 5 Days | Deaths within the First 5 Days (Children<18) Years | 0 participants |
Secondary
Number of Participants Who Experienced Clinical Symptoms
Measured daily through Study Day 14 and then again on Study Day 28
Time frame: Measured through Day 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Cough | 71 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Sore Throat | 29 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Fatigue | 60 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Nasal Discharge | 40 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Difficulty Breathing | 54 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Headache | 21 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Muscle Pain | 28 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Nausea | 4 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Vomiting | 5 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Experienced Clinical Symptoms | Diarrhea | 4 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Nausea | 8 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Cough | 75 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Headache | 13 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Sore Throat | 23 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Diarrhea | 5 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Fatigue | 54 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Muscle Pain | 18 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Nasal Discharge | 25 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Vomiting | 7 Participants |
| Placebo | Number of Participants Who Experienced Clinical Symptoms | Difficulty Breathing | 51 Participants |
p-value: 0.4277Fay - Shaw
p-value: 0.4022Fay-Shaw
p-value: 0.5957Fay-Shaw
p-value: 0.0446Fay-Shaw
p-value: 0.8628Fay-Shaw
p-value: 0.16Fay-Shaw
p-value: 0.1234Fay-Shaw
p-value: 0.2155Fay-Shaw
p-value: 0.5176Fay-Shaw
p-value: 0.6986Fay-Shaw
Secondary
Number of Participants Who Require Oxygen Use
Number of study participants who require use of supplemental oxygen at time points (e.g., Any time, Day 0, Day 3, Day 7, Day 14, and Day 28)
Time frame: Measured through Day 28 or participants' last day of hospitalization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Number of Participants Who Require Oxygen Use | Day 7 | 28 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Require Oxygen Use | Day 0 | 114 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Require Oxygen Use | Day 14 | 6 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Require Oxygen Use | Day 3 | 74 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Require Oxygen Use | Day 28 | 6 Participants |
| Nitazoxanide (NTZ) | Number of Participants Who Require Oxygen Use | Any Time | 119 Participants |
| Placebo | Number of Participants Who Require Oxygen Use | Day 28 | 4 Participants |
| Placebo | Number of Participants Who Require Oxygen Use | Any Time | 118 Participants |
| Placebo | Number of Participants Who Require Oxygen Use | Day 3 | 80 Participants |
| Placebo | Number of Participants Who Require Oxygen Use | Day 7 | 27 Participants |
| Placebo | Number of Participants Who Require Oxygen Use | Day 14 | 5 Participants |
| Placebo | Number of Participants Who Require Oxygen Use | Day 0 | 116 Participants |
p-value: 0.681Fay - Shaw
p-value: 0.341Fay-Shaw
p-value: 0.321Fay-Shaw
p-value: 0.957Fay-Shaw
p-value: 0.788Fay-Shaw
p-value: 0.544Fay-Shaw
Secondary
Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28)
Number of study participants (e.g., adult and children) admitted to the intensive care unit (ICU) by time point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.
Time frame: Measured through Day 28 or participants' last day in the ICU
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | 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 | 1 Participants |
| Placebo | 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 | 2 Participants |
| Placebo | 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 |
| Placebo | 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 | 1 Participants |
| Placebo | 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 |
| Placebo | 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 |
p-value: 0.671Fay - Shaw
p-value: 0.325Fay-Shaw
p-value: 0.987Fay-Shaw
p-value: 0.987Fay-Shaw
p-value: 0.311Fay-Shaw
Secondary
Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study
Number of study participants (e.g., adults and children) with the presence of a complication (pneumonia, respiratory failure requiring mechanical ventilation, acute respiratory distress syndrome \[ARDS\], sepsis, or bronchiolitis) during the study .
Time frame: Measured through Day 28 or participants' last day of hospitalization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | 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 | 7 Participants |
| Placebo | 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 | 73 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
p-value: 0.928Fay - Shaw
p-value: 0.9669Fay-Shaw
p-value: 0.0832Fay-Shaw
Secondary
Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)
Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.
Time frame: Measured through Day 3
Population: Efficacy analysis of Intent to Treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0) | No Detectable Virus on Day 3 | 17 Participants |
| Nitazoxanide (NTZ) | Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0) | Same Detectable Virus on Day 3 | 56 Participants |
| Nitazoxanide (NTZ) | Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0) | Different Detectable Virus on Day 3 | 6 Participants |
| Placebo | Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0) | No Detectable Virus on Day 3 | 19 Participants |
| Placebo | Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0) | Same Detectable Virus on Day 3 | 61 Participants |
| Placebo | Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0) | Different Detectable Virus on Day 3 | 9 Participants |
p-value: 0.9785Fay-Shaw
Secondary
Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28)
Study participants (e.g., adults, children) requiring mechanical ventilation (e.g., intubation/extubation) at study time points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.
Time frame: Measured through Day 28 or participants' last day of hospitalization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Nitazoxanide (NTZ) | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 | 1 Participants |
| Placebo | 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 |
| Placebo | 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 | 2 Participants |
p-value: 0.973Fay - Shaw
p-value: 0.575Fay-Shaw
p-value: 0.548Fay-Shaw
p-value: 0.987Fay-Shaw
p-value: 0.987Fay-Shaw
p-value: 0.987Fay-Shaw
Secondary
Use of Systemic Corticosteroids
Number of study participants taking Systemic Steroids during first 5 days.
Time frame: Measured within First 5 Days
Population: The analysis was based on the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | DESMOPRESSIN | 0 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | Subjects Taking Systemic Steroids - First 5 Days | 78 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | DEXAMETHASONE | 4 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | GLUCOCORTICOIDS (Fluticasone/Vilanterol) | 0 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | HYDROCORTISONE | 5 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | LEVOTHYROXINE | 6 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | LEVOTHYROXINE SODIUM | 1 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | METHYLPREDNISOLONE | 35 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | NOVOTHYRAL | 0 Participants |
| Nitazoxanide (NTZ) | Use of Systemic Corticosteroids | PREDNISONE | 43 Participants |
| Placebo | Use of Systemic Corticosteroids | METHYLPREDNISOLONE | 26 Participants |
| Placebo | Use of Systemic Corticosteroids | DESMOPRESSIN | 1 Participants |
| Placebo | Use of Systemic Corticosteroids | LEVOTHYROXINE | 8 Participants |
| Placebo | Use of Systemic Corticosteroids | Subjects Taking Systemic Steroids - First 5 Days | 70 Participants |
| Placebo | Use of Systemic Corticosteroids | PREDNISONE | 35 Participants |
| Placebo | Use of Systemic Corticosteroids | DEXAMETHASONE | 5 Participants |
| Placebo | Use of Systemic Corticosteroids | LEVOTHYROXINE SODIUM | 1 Participants |
| Placebo | Use of Systemic Corticosteroids | GLUCOCORTICOIDS (Fluticasone/Vilanterol) | 1 Participants |
| Placebo | Use of Systemic Corticosteroids | NOVOTHYRAL | 1 Participants |
| Placebo | Use of Systemic Corticosteroids | HYDROCORTISONE | 3 Participants |