STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects

Phase 1

Conditions: Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
MedDRA version: 20.0Level: HLTClassification code 10033796Term: Parainfluenzae viral infectionsSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2018-004318-16-BE

Lead Sponsor: Ansun Biopharma, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 132

Inclusion Criteria

Subjects must meet the following inclusion criteria at the time of randomization to be eligible for participation in this study:
1. Males and females =12 years of age
2. SpO2 < 92% on room air while at rest and requires supplemental oxygen =2 LPM at the time of randomization. Subjects who also require invasive mechanical ventilation (MV) or non-invasive positive pressure ventilation (CPAP or bi-PAP) are eligible, although ventilator support is not mandatory
3. 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
?- Treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) at any time in the past?
- Treated with chemotherapy for solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past
4. Confirmed PIV lower tract disease for subjects within the screening period (3 days prior to randomization) will be defined as PIV detection in one of the following:
?- bronchoalveolar lavage (BAL)
?- lung biopsy
?- upper respiratory viral sample:
o Tracheal aspirate OR sputum OR nasopharyngeal swab (NPS) OR nasopharyngeal wash
AND
o Radiographic finding of a new or worsening pulmonary infiltrate, bronchiolitis, OR pneumonitis that temporally is associated with diagnosis of PIV
infection on chest x-ray or CT scan.
PIV diagnosis test will use any of the sample types listed above and will be analyzed at local laboratory using one of the following methods:
?- Respiratory virus panel (RVP),
?- Qualitative/quantitative polymerase chain reaction (PCR) or
?- Direct Fluorescent Antibody (DFA)
Note: If PIV infection is highly suspected but negative result with DFA, it is recommended to retest for PIV using RVP or PCR.
5. If female, patient must not be pregnant or nursing, and is either:
?- Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy; or
?- Of childbearing potential and:
o Is practicing an effective method of contraception (e.g., oral/parenteral contraceptives or a barrier
method), or
o Has a vasectomized partner (at least 6 months postvasectomy
procedure), or
o Is currently abstinent from sexual intercourse, AND must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening
Women of childbearing potential must be willing to practice the chosen contraceptive method or remain abstinent during the conduct of the study and for at least 30 days after last dose of study medication.
Acceptable methods of contraception include:
o Male or female condom with or without spermicides (a female condom should not be used at the same time as a male condom due to risk of tearing)
o Female barrier contraception (such as diaphragm, cervical cap, or sponge) with spermicide
o Continuous use of an intrauterine device for at least 90 days before the first dose of study drug
o Oral, implanted, injected, or vaginal hormonal contraceptives, if successfully used for at least 60 days before the first dose of study drug.
Additional contraception requirements may need to be followed according to local regulations and/or requirements.
6. Non-vasectomized males are required to practice effective birth control methods (e.g., abstinence, use of a condom or u

Exclusion Criteria

Subjects who meet any of the following exclusion criteria will not be enrolled in this study:
1. 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
2. Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV within 48 hours prior to the first dose of study drug. Ribavirin treatment for current Respiratory Syncytial Virus (RSV) and/or Metapneumovirus (MPV) is allowed and will not require washout
3. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) =3x ULN AND Total Bilirubin (TB) =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 assessment) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded
4. Female subjects with positive serum pregnancy test, planning become pregnant, breastfeeding, or planning to breastfeed throughout the study period
5. Subjects taking any other investigational drugs used to research or treat PIV
6. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
7. Subjects with known hypersensitivity to DAS181 and/or any of its components
8. Subjects with ongoing sepsis/septic shock

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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