The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube
Placebo to match presatovir administered orally or via nasogastric tube
City of Hope
Duarte, California, United States
University of Chicago
Chicago, Illinois, United States
John Hopkins
Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.
Time frame: Baseline to Day 9
Number of Supplemental O2-Free Days Through Day 28
Time frame: Up to Day 28
Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28
Time frame: Up to Day 28
Percentage of All-Cause Mortality Among Participants Through Day 28
Time frame: Up to Day 28
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Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
New York Weill Cornell Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchison Cancer Research Center
Seattle, Washington, United States
...and 7 more locations