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
Ansun Biopharma, Inc.
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.
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 mechan…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia. 2. Immunocompromised, as defined by one or more of the following: * Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past * Received a solid organ transplant at any time in the past * Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past * Has an immunodeficiency du…
Interventions
- DrugDAS181
DAS181 4.5mg nebulized qd x 7 OR 10 days
- DrugPlacebo
Placebo nebulized qd x 7 OR 10 days
- DrugDAS181 COVID-19
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
- DrugDAS181 OL
DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg
Locations (67)
- City of Hope cancer CenterDuarte, California
- UCLALos Angeles, California
- University of California Davis Health SystemSacramento, California
- University of California San Diego Medical CenterSan Diego, California
- Children's Hospital ColoradoAurora, Colorado
- Sylvester Comprehensive Cancer Center, University of Miami Health SystemMiami, Florida