NCT03808922

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Ansun Biopharma, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

Detailed description

Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria: Cohort 1: All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet all of the following criteria: 1.1 Meet criteria for being severely immunocompromised 1.2 Prior to the onset of PIV infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition (e.g., COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection 1.3 At the time of randomization are not on mechanical, bi-level or continuous positive airway pressure (Bi-PAP or CPAP) ventilation 1.4 Have no known concurrent respiratory viral coinfection(s) Cohort 2: All eligible subjects in the PoI who are ≥18 year old with a PIV infection (including those with PIV and another SAD-RV) who do not meet one or more of the listed criteria for Cohort 1. Cohort 3: All eligible subjects in the PoI who are \<18 year old subjects with a PIV infection (including those with PIV and another concurrent SAD-RV). There is no lower age limit for this cohort. Cohort 4: All eligible subjects in the PoI with a respiratory infection due to any SAD-RV infection except PIV. Eligible subjects with both PIV and an additional concurrent SAD-RV, will be enrolled for either Cohorts 2 or 3 depending on their age. There is no lower age limit for this cohort. Sub-Study: Patients with Severe COVID-19

Conditions

• Lower Respiratory Tract Infection
• Parainfluenza
• Immunocompromised
• COVID-19

Interventions

Type	Name	Description
DRUG	DAS181	DAS181 4.5mg nebulized qd x 7 OR 10 days
DRUG	Placebo	Placebo nebulized qd x 7 OR 10 days
DRUG	DAS181 COVID-19	DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
DRUG	DAS181 OL	DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg

Timeline

• Start date: 2019-05-23
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2019-01-18
• Last updated: 2024-11-20

Locations

67 sites across 8 countries: United States, Australia, China, Denmark, France, Hong Kong, South Korea, Taiwan

Regulatory

• FDA-regulated drug study