DAS181 in Patients With Parainfluenza
- Parainfluenza is a virus that can cause infections in people. Most people infected with this virus have mild symptoms including fever, cough, red eyes, or runny nose (a common cold). Some people, especially those with a weakened immune system, get very sick from this virus. They may have difficulty breathing or develop lung infections. Currently, there are no specific treatments for parainfluenza. However, a drug called DAS181 may make the virus go away faster. Researchers are interested in testing DAS181 to see if it is safe and effective against parainfluenza.
- To test the safety and effectiveness of DAS181 as a treatment for parainfluenza.
- Individuals at least 18 years of age who have the parainfluenza virus and have developed symptoms within the past 10 days.
- Participants will be screened with a physical exam, medical history, and questions about symptoms and activity levels. Participants will also have a lung function test and provide blood and nasal fluid samples.
- DAS181 is an inhaled medication, and everyone will receive a study medication inhaler. Participants will receive either DAS181 or a placebo through the inhaler. They will take it once every day for 5 days.
- Participants will have monitoring visits on days 2, 4, 7, 10, 14, and 28 to provide blood and nasal fluid samples and have a lung function test.
- Participants who still have the virus in their system on Day 28 will return to the clinic on Day 42 for more tests. Participants who still have the virus in their system on Day 42 will return to the clinic on Day 56 for more tests.
- Participants will have followup visits 6 months and 1 year after the start of the study....
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Phase II Study of DAS181 in Patients With Parainfluenza Infection|
- Number patients with at least 1 grade 3/4/SAE that are possibly, probably, or definitely related to the study product by Study Day 28. [ Time Frame: study day 28 ] [ Designated as safety issue: Yes ]
- Virologic Endpoints: Viral shedding by qualitative PCR or culture. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Clinical Endpoints: Clinical symptoms, Fever, Radiographic evidence of lower tract disease by CT (if obtained clinically), Death, Hospitalization, Use of supplemental oxygen. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
20 mg per day of DAS181-FO3 for 5 days
Placebo Comparator: 2
20 mg per day of Lactose for 5 days
Parainfluenza virus (PIV) infections cause considerable morbidity in the immunocompromised population. In the immunocompetent population, PIV is usually self-limited, but can cause more severe disease including pneumonia and tracheobronchitis in adults, and croup and bronchiolitis in young children. DAS181, an inhaled sialidase, cleaves the binding site of PIV from respiratory mucosal cells limiting the ability of PIV to infect new cells. This may improve outcomes in patients with PIV infections.
This exploratory randomized double-blind Phase 2 study will assess the safety and tolerability, and explore the efficacy of DAS181 versus placebo for the treatment of parainfluenza. Thirty eligible patients diagnosed with parainfluenza will be randomized in a 2:1 allocation to receive either DAS181-F02 formulation (10 mg times 5 days) or placebo. Subjects will be followed on Study Days 0, 2, 4, 7, 10, 14, 28, 180, and 365 with a series of clinical, pulmonary function, functional status, virologic, and safety assessments.
|Principal Investigator:||Richard T Davey, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|