Parainfluenza Infection Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of DAS181 in Patients With Parainfluenza Infection
Background:
- 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.
Objectives:
- To test the safety and effectiveness of DAS181 as a treatment for parainfluenza.
Eligibility:
- Individuals at least 18 years of age who have the parainfluenza virus and have developed
symptoms within the past 10 days.
Design:
- 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.
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.
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