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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Identical Placebo Comparator |
|
| ALS-008176 | Experimental | ALS-008176 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALS-008176 | Drug | ALS-008176 tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From prior to first dose to study day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from baseline to non-detectability of RSV from nasal swab | Time from baseline to non-detectability of RSV from nasal swab | From prior first dose to study day 28 |
| Percent of subjects with undetectable RSV by qPCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbie Oey | Alios Biopharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake Internal Med. Assoc. | Eustis | Florida | 32726 | United States | ||
| The Research Center, Inc. |
No data will be shared
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| Drug |
Identical placebo tablets |
|
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
| 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 | 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 | From before first dose to study day 2 |
| Duration of hospital stay | Duration of hospital stay | 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). | From screening to study day 28 |
| PK parameters: Cmax | PK parameters in plasma following repeat dose administration: Cmax | From first dose to study day 28 |
| PK parameters: tmax | PK parameters in plasma following repeat dose administration: tmax | From first dose to study day 28 |
| PK parameters: AUClast | PK parameters in plasma following repeat dose administration: AUClast | From first dose to study day 28 |
| PK parameters: t1/2 | PK parameters in plasma following repeat dose administration: t1/2 | From first dose to study day 28 |
| PK parameters: AUC0 tau | PK parameters in plasma following repeat dose administration: AUC0 tau | From first dose to study day 28 |
| Hialeah |
| Florida |
| 33013 |
| United States |
| JDH Medical Group LLC | Miami | Florida | 33186 | United States |
| St Lucie Medical Center | Port Saint Lucie | Florida | 34952 | United States |
| Tampa Genereal Hospital | Tampa | Florida | 33606 | United States |
| Infectious Disease Specialists of Atlanta | Atlanta | Georgia | 30033 | United States |
| Kentucky Lung Clinic, PSC | Hazard | Kentucky | 41701 | United States |
| Bronson Methodist Hosp. Ped | Kalamazoo | Michigan | 49007 | United States |
| William Beaumont Hospital | Troy | Michigan | 48085 | United States |
| University of Missouri- Clinical Research Center | Columbia | Missouri | 65212 | United States |
| Washington Univ School of Med | St Louis | Missouri | 63110 | United States |
| Westmead Hospital | Northmead | New South Wales | 2145 | Australia |
| Cairns Hospital | Cairns | Queensland | 4870 | Australia |
| Mater Adult Hospital | South Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Monash Heal.-Monash Lung&Sleep | Clayton | Victoria | 3168 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Wellington Regional Hospital | Newtown | Wellington Region | 6021 | New Zealand |
| Raffles Hospital | Singapore | 188770 | Singapore |
| Taipei Med. Uni-Shuang Ho Hosp | New Taipei City | 235 | Taiwan |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000597470 | 4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine |
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