To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
Administered by nebulization once daily for 5 days
Administered by nebulization once daily for 5 days
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Time frame: 180 days after randomization
Proportion of patients with FEV1 >80% of pre-infection baseline value
Time frame: 90 and 180 days after randomization
RSV symptoms as measured by mean cumulative daily total symptom score
Time frame: 14 days after randomization
Viral load as measured by viral area under the curve (AUC)
Time frame: 6 days after randomization
All cause mortality
Time frame: Throughout the study
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Clinical Site
Phoenix, Arizona, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
Denver, Colorado, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Ann Arbor, Michigan, United States
...and 23 more locations