This study is being to see how effective and safe ALS-008176 is in treating adults in the hospital with a Respiratory Syncytial Virus-Related Illness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
ALS-008176 tablets
Identical placebo tablets
Lake Internal Med. Assoc.
Eustis, Florida, United States
The Research Center, Inc.
AUC of RSV RNA
Area under the curve (AUC) of RSV ribonucleic acid (RNA) from nasal swabs immediately prior to 1st dose of study drug (baseline) until Day 7.
Time frame: From prior to first dose to study day 7
Time from baseline to non-detectability of RSV from nasal swab
Time from baseline to non-detectability of RSV from nasal swab
Time frame: From prior first dose to study day 28
Percent of subjects with undetectable RSV by qPCR
Percent of subjects with undetectable RSV by qPCR on Day 3, Day 5, and every other day until 2 days after last dose from nasal swab
Time frame: From study day 3, and every two days until study day 7
Peak post-baseline viral load
Peak post-baseline viral load from nasal swab
Time frame: From before first dose to study day 28
Rate of decline from baseline in viral load during treatment from nasal swab
Rate of decline from baseline in viral load during treatment from nasal swab
Time frame: From before first dose to study day 2
Duration of hospital stay
Duration of hospital stay
Time frame: From first dose to study day 28
Safety data: Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine).
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Hialeah, Florida, United States
JDH Medical Group LLC
Miami, Florida, United States
St Lucie Medical Center
Port Saint Lucie, Florida, United States
Tampa Genereal Hospital
Tampa, Florida, United States
Infectious Disease Specialists of Atlanta
Atlanta, Georgia, United States
Kentucky Lung Clinic, PSC
Hazard, Kentucky, United States
Bronson Methodist Hosp. Ped
Kalamazoo, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
University of Missouri- Clinical Research Center
Columbia, Missouri, United States
...and 11 more locations
Time frame: From screening to study day 28
PK parameters: Cmax
PK parameters in plasma following repeat dose administration: Cmax
Time frame: From first dose to study day 28
PK parameters: tmax
PK parameters in plasma following repeat dose administration: tmax
Time frame: From first dose to study day 28
PK parameters: AUClast
PK parameters in plasma following repeat dose administration: AUClast
Time frame: From first dose to study day 28
PK parameters: t1/2
PK parameters in plasma following repeat dose administration: t1/2
Time frame: From first dose to study day 28
PK parameters: AUC0 tau
PK parameters in plasma following repeat dose administration: AUC0 tau
Time frame: From first dose to study day 28