Randomized, Double-blind, Placebo-controlled Phase II Study to Examine the Effects of DAS181 in Immunocompromised Patients With Parainfluenza Infection (DAS181-2-05)

This protocol will seek to enroll immunocompromised patients diagnosed with parainfluenza infection.

• Drug: DAS181 dry powder, formulation F02
• Drug: Lactose Placebo

• Experimental: DAS181
  DAS181-F02, 10mg qd x 5 days
  Intervention: Drug: DAS181 dry powder, formulation F02
• Placebo Comparator: Lactose Placebo
  Intervention: Drug: Lactose Placebo

Inclusion Criteria:

• Age > than or equal to 12 years, male or female;
• Specific for LRI subjects, evidence of new parenchymal abnormalities by chest imaging
• Able to provide informed consent or ascent

• Immunocompromised, as defined by one of the following:

  • Allogeneic hematopoietic cell transplantation (HCT)
  • Lung or lung-heart transplantation
  • Patients treated with chemotherapy for hematologic malignancies or autologous HCt within the past 6 months prior to screening

• Specific for Upper Respiratory Infection subjects, a total symptom severity score of 3 or greater from one or more respiratory or non-respiratory symptoms:

  • Respiratory symptoms include rhinorrhea, hoarseness, sneezing, wheezing, sore throat, cough, earache, shortness of breath, pleuritic chest pain, hemoptysis
  • Non-respiratory symptoms include fever, chills, myalgia, malaise, arthralgia
• Rapid culture, DFA or qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study)

• Female patients of child-bearing age who are capable of conception must meet the following criteria:

  • Have been sexually abstinent or have used contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device [IUD], or barrier methods including condoms) during the 4 weeks prior to date of screening (3 months prior to enrollment for oral/hormonal contraceptives)
  • Agree to be sexually abstinent or use contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device [IUD], or barrier methods including condoms) from the date of screening through 4 weeks after the last dose of study drug

Exclusion Criteria:

• Mechanical ventilation that would preclude drug inhalation.
• Current clinical evidence of a recognized or suspected uncontrolled non-PIV infectious illness with onset prior to screening.
• Alanine aminotransferase or alkaline phosphatase greater than 5 times normal, within 30 days of screening.
• Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding.
• Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
• Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule.
• Known concurrent respiratory co-infection at screening.
• Subjects treated with oral, aerosolized or IV ribavirin.
• Investigational drug used to research or treat PIV
• Subjects with QTc interval > than or equal to 500msec