This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
238
Oral capsule
Oral capsule
Cahaba Research
Birmingham, Alabama, United States
Precision Trials AZ
Phoenix, Arizona, United States
Time to alleviation of symptoms
Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Time frame: 14 days
Proportion of subjects whose symptoms have been alleviated at each time point through Day 5
Time frame: 5 days
Change from baseline in composite symptom score at each time point through Day 5
Time frame: 5 days
Time to resolution of fever (body temperature equal to or less than 37ºC)
Time frame: 14 days
Body temperature at each time point through Day 5
Time frame: 5 days
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Time frame: 14 days
Time to resumption of normal activity
Time frame: 14 days
Use of rescue medication (acetaminophen)
Time frame: 14 days
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