Status:
RECRUITING
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
Lead Sponsor:
Ansun Biopharma, Inc.
Conditions:
Lower Respiratory Tract Infection
Parainfluenza
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria: Cohort 1: All eligible subjects in the PoI who are...
Eligibility Criteria
Inclusion
- At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
- Immunocompromised, as defined by one or more of the following:
- 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
- Has an immunodeficiency due to congenital abnormality (only applicable to subjects age \< 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)
- Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
- If female, subject must meet one of the following conditions:
- Not be of childbearing potential or
- Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
- Non-vasectomized males are required to practice effective birth control methods
- Capable of understanding and complying with procedures as outlined in the protocol
- Provides signed informed consent prior to the initiation of any screening or study-specific procedures
- For COVID-19 sub study:
- Be ≥18 years of age
- Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
- Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
- Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
- Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
- Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
Exclusion
- 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.
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
- Subjects with known hypersensitivity to DAS181 and/or any of its components
- Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria:
- Has evidence of vital organ failure outside of the lung (e.g., liver, kidney)
- Requires vasopressors to maintain blood pressure
- For COVID-19 sub study:
- Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
- Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted).
- Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
- Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
- Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria:
- Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)
- Require vasopressors to maintain blood pressure
- Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
Key Trial Info
Start Date :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT03808922
Start Date
May 23 2019
End Date
August 31 2025
Last Update
November 20 2024
Active Locations (67)
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1
City of Hope cancer Center
Duarte, California, United States, 91010
2
UCLA
Los Angeles, California, United States, 90024
3
University of California Davis Health System
Sacramento, California, United States, 95817
4
University of California San Diego Medical Center
San Diego, California, United States, 92093