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To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-RSV01 | Active Comparator |
| |
| Normal saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-RSV01 | Drug | Administered by nebulization once daily for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients | 180 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with FEV1 >80% of pre-infection baseline value | 90 and 180 days after randomization | |
| RSV symptoms as measured by mean cumulative daily total symptom score | 14 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Zamora, MD | University of Colorado, Denver | Principal Investigator |
| Alan Glanville, MB BS MD Syd, FRACP | St. Vincents Hospital NSW W Australia | Principal Investigator |
| Jens T Gottlieb, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Phoenix | Arizona | 85013 | United States | ||
| Clinical Site |
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| Normal Saline |
| Drug |
Administered by nebulization once daily for 5 days |
|
| Viral load as measured by viral area under the curve (AUC) | 6 days after randomization |
| All cause mortality | Throughout the study |
| Los Angeles |
| California |
| 90033 |
| United States |
| Clinical Site | Denver | Colorado | 80202 | United States |
| Clinical Site | Tampa | Florida | 33606 | United States |
| Clinical Site | Atlanta | Georgia | 30322 | United States |
| Clinical Site | Chicago | Illinois | 60153 | United States |
| Clinical Site | Chicago | Illinois | 60637 | United States |
| Clinical Site | Boston | Massachusetts | 02114 | United States |
| Clinical Site | Boston | Massachusetts | 02115 | United States |
| Clinical Site | Ann Arbor | Michigan | 48109 | United States |
| Clinical Site | St Louis | Missouri | 63110 | United States |
| Clinical Site | New York | New York | 10032 | United States |
| Clinical Site | Cleveland | Ohio | 44195 | United States |
| Clinical Site | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Site | Nashville | Tennessee | 37232 | United States |
| Clinical Site | Dallas | Texas | 75390 | United States |
| Clinical Site | Houston | Texas | 77030 | United States |
| Clinical Site | Darlinghurst | New South Wales | 2010 | Australia |
| Clinical Site | Adelaide | South Australia | 5000 | Australia |
| Clinical Site | Melbourne | Victoria | 3004 | Australia |
| Clinical Site | Perth | Western Australia | 6001 | Australia |
| Clinical Site | Vienna | 1090 | Austria |
| Clinical Site | Edmonton | Alberta | T6G 2E1 | Canada |
| Clinical Site | Toronto | Ontario | M5G 2N2 | Canada |
| Clinical Site | Paris | 75908 | France |
| Clinical Site | Strasbourg | 67091 | France |
| Clinical Site | Berlin | 10117 | Germany |
| Clinical Site | Essen | 45239 | Germany |
| Clinical Site | Hamburg | 20246 | Germany |
| Clinical Site | Hanover | 30625 | Germany |
| Clinical Site | Homburg/Saar | 66421 | Germany |
| Clinical Site | Leipzig | 04103 | Germany |
| 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 |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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