Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.

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

Disqualifiers

Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment

Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for >1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded

Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug

Subjects taking any other investigational drug used to treat pulmonary infection.

Trial design

Treatments tested in this trial

  • DAS181
  • Placebo
  • DAS181 COVID-19
  • DAS181 OL

Treatment groups

274 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

28
Australia
Westmead Hospital2145, SydneyNew South Wales, Australia
China
Shanghai Pulmonary Hospital200433, YangpuShanghai Municipality, China
South Korea
Samsung Medical Center06351, SeoulGyeonggi-do, South Korea
Seoul National University Hospital03080, SeoulGyeonggi-do, South Korea

Sponsors and collaborators

Ansun Biopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov