Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
- at Los Angeles, California and other locations
- study startestimated completion
It also contains a sub-study to enroll patients with severe COVID-19.
A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria:
All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet all of the following criteria:
1.1 Meet criteria for being severely immunocompromised 1.2 Prior to the onset of PIV infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition (e.g., COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection 1.3 At the time of randomization are not on mechanical, bi-level or continuous positive airway pressure (Bi-PAP or CPAP) ventilation 1.4 Have no known concurrent respiratory viral coinfection(s)
All eligible subjects in the PoI who are ≥18 year old with a PIV infection (including those with PIV and another SAD-RV) who do not meet one or more of the listed criteria for Cohort 1.
All eligible subjects in the PoI who are <18 year old subjects with a PIV infection (including those with PIV and another concurrent SAD-RV). There is no lower age limit for this cohort.
All eligible subjects in the PoI with a respiratory infection due to any SAD-RV infection except PIV. Eligible subjects with both PIV and an additional concurrent SAD-RV, will be enrolled for either Cohorts 2 or 3 depending on their age. There is no lower age limit for this cohort.
Patients with Severe COVID-19
Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19, PIV, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun, Infections, Communicable Diseases, Respiratory Tract Infections, Paramyxoviridae Infections, DAS181, DAS181 COVID-19, DAS181 OL
You can join if…
- 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:
- 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
You CAN'T join if...
- 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
accepting new patients
Los Angeles California 90024 United States
- City of Hope cancer Center
accepting new patients
Duarte California 91010 United States
- accepting new patients
- Start Date
- Completion Date
- Ansun Biopharma, Inc.
- Phase 3 research study
- Study Type
- Expecting 274 study participants
- Last Updated