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This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAS181 | Experimental | DAS181-F02, 4.5 mg qd x 10 days |
|
| Lactose Placebo | Placebo Comparator | placebo, 4.5 mg qd x 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAS181 dry powder, formulation F02 | Drug |
| ||
| Lactose Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Stability | Clinical stability survival (CSS) rate is defined as subjects who meet the clinical stability criteria and are alive at Study Day 45 (Responders) compared to those who have not met clinical stability criteria or have expired regardless of stability status (Non-responders) | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Stability | Clinical stability (CS) rate excluding survival status: Clinical stability (CS) rate is defined as subjects who reached clinical stability criteria (Responders) compared to those subjects who did not meet the clinical stability criteria (Non-responders). | 45 days |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic-Arizona | Phoenix | Arizona | 85054 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33569576 | Derived | Chemaly RF, Marty FM, Wolfe CR, Lawrence SJ, Dadwal S, Soave R, Farthing J, Hawley S, Montanez P, Hwang J, Ho JH, Lewis S, Wang G, Boeckh M. DAS181 Treatment of Severe Lower Respiratory Tract Parainfluenza Virus Infection in Immunocompromised Patients: A Phase 2 Randomized, Placebo-Controlled Study. Clin Infect Dis. 2021 Aug 2;73(3):e773-e781. doi: 10.1093/cid/ciab113. |
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|
Mortality rate at Day 45 |
| 45 days |
| Clinical Stability | Time (in days) to reach clinical stability (including survival status or excluding survival status) | 45 days |
| Clinical Stability | Time (in days) to death | 45 days |
| Clinical Stability | Time (in days) to hospital discharge of CS non-responders and death | 45 days |
| Duarte |
| California |
| 91010 |
| United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| UC Davis | Sacramento | California | 95817 | United States |
| Ansun Biopharma, Inc | San Diego | California | 92121 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 42367 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Children's Mercy Hospital | Kansas City | Kansas | 64108 | United States |
| University of Kansas | Kansas City | Kansas | 66160 | United States |
| John Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota, School of Medicine | Minnesota City | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College/New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Weill Cornell Medical College-Peds | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Stonybrook | Stony Brook | New York | 11794-88183 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's | Columbus | Ohio | 43205 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt- Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Virginia Commonwealth | Richmond | Virginia | 23298 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Fred Hutchinson Cencer Research Center | Seattle | Washington | 98109-1024 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D018184 | Paramyxoviridae Infections |
| ID | Term |
|---|---|
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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