Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness

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)