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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)