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A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen (DAS181-2-05)
This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection.
Details
| Lead sponsor | Ansun Biopharma, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 111 |
| Start date | 2014-03 |
| Completion | 2016-12-15 |
Conditions
- Parainfluenza
Interventions
- DAS181 dry powder, formulation F02
- Lactose Placebo
Primary outcomes
- Clinical Stability — 45 days
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)
Countries
United States