Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAnsun Biopharma, Inc.
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 groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov