Clinical Trial: 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
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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 Oxyge
Brief Summary: This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection.
Detailed Summary:
Sponsor: Ansun Biopharma, Inc.
Current Primary Outcome: Clinical Stability [ Time Frame: 45 days ]
Original Primary Outcome: Confirm the safety of DAS181 in the immunocompromised PIV patient population [ Time Frame: 90 days ]
Current Secondary Outcome:
- Clinical Stability [ Time Frame: 45 days ]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).
- Mortality [ Time Frame: 45 days ]Mortality rate at Day 45
- Clinical Stability [ Time Frame: 45 days ]Time (in days) to reach clinical stability (including survival status or excluding survival status)
- Clinical Stability [ Time Frame: 45 days ]Time (in days) to death
- Clinical Stability [ Time Frame: 45 days ]Time (in days) to hospital discharge of CS non-responders and death
Original Secondary Outcome:
Information By: Ansun Biopharma, Inc.
Dates:
Date Received: July 17, 2012
Date Started: March 2014
Date Completion: December 2016
Last Updated: August 2, 2016
Last Verified: August 2016
