Clinical Trials List
Protocol NumberDAS181-3-01
NCT Number(ClinicalTrials.gov Identfier)NCT03808922
2019-11-17 - 2021-12-31
Phase III
Recruiting2
ICD-10B33.8
Other specified viral diseases
ICD-10B34.1
Enterovirus infection, unspecified
ICD-10B34.2
Coronavirus infection, unspecified
ICD-10B34.3
Parvovirus infection, unspecified
ICD-10B34.4
Papovavirus infection, unspecified
ICD-10B34.8
Other viral infections of unspecified site
ICD-10B97.19
Other enterovirus as the cause of diseases classified elsewhere
ICD-10B97.21
SARS-associated coronavirus as the cause of diseases classified elsewhere
ICD-10B97.29
Other coronavirus as the cause of diseases classified elsewhere
ICD-10B97.5
Reovirus as the cause of diseases classified elsewhere
ICD-10B97.6
Parvovirus as the cause of diseases classified elsewhere
ICD-10B97.81
Human metapneumovirus as the cause of diseases classified elsewhere
ICD-10B97.89
Other viral agents as the cause of diseases classified elsewhere
ICD-9079.89
Other specified viral infection in conditions classified elsewhere and of unspecified site
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
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Ansun Biopharma, Inc.
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Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ya-Ting Hsu Division of General Internal Medicine
- Ya-Ping Chen Division of General Internal Medicine
- Tsai-Yun Chen Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭律成 Division of Thoracic Medicine
- Chun-yi Lu Division of Pediatrics
- SUNG-CHING PAN Division of Infectious Disease
- MING YAO Division of Hematology & Oncology
- 莊祐中 Division of Infectious Disease
- 阮聖元 Division of Thoracic Medicine
- Jung-Yien Chien Division of Thoracic Medicine
- 曾文斌 Division of Emergency Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Lower Respiratory Tract Parainfluenza Infection
Objectives
Primary Efficacy Objective
To demonstrate the efficacy of DAS181 on clinical outcome compared to placebo as
measured by percentage of RTRA Responders by Day 28.
Secondary Efficacy Objectives
To evaluate all-cause mortality rate in DAS181 compared to placebo
To evaluate percent of patients who RTRA by Day 21 in DAS181 compared to placebo
To evaluate time (in days) to cessation of oxygen support in DAS181 compared to
placebo
To evaluate rate of CS by Day 28 in DAS181 compared to placebo
To determine the percent of subjects discharged each week (without mortality and
hospice) up to Day 35 in DAS181 compared to placebo
To determine the initial length of hospital stay (without mortality and hospice) in
DAS181 compared to placebo
To evaluate total length of hospital stay up to Day 35 in DAS181 compared to placebo
To evaluate PIV-related mortality rate in DAS181 compared to placebo
Safety Objectives
To assess the safety and tolerability of DAS181 treatment in the PoI in DAS181 compared to
placebo
Exploratory Objectives
To evaluate pulmonary function
To characterize pharmacokinetics (PK) of DAS181
To evaluate duration of Intensive Care Unit (ICU) stay during initial admission
To evaluate viral load
To evaluate viral shedding
To evaluate immunogenicity
To evaluate drug resistance in subjects treated with DAS181
To characterize change in bacterial flora over time
To determine the number of subjects who require supplemental oxygen use after being
assessed as RTRA
Test Drug
DAS181
Active Ingredient
DAS181
Dosage Form
Atomizer
Dosage
10 mL
Endpoints
Primary Efficacy Endpoint (Cohort 1)
Percent of subjects who ‘Return to Room Air’ by Day 28 (RTRA28).
Secondary Efficacy Endpoints(Cohort 1)
a. All-cause mortality rate at Day 28
b. Percent of subjects who RTRA by Day 21
c. Time (in days) to cessation of oxygen support
d. Percent of subjects who achieve CS by Day 28
e. Percent of subjects discharged (without mortality and hospice) by Day 14, 21, 28 and 35
f. Time (in days) to first hospital discharge (without hospice)
g. Total number of inpatients days (up to Day 35)
h. PIV-related mortality rate at Day 28
i. PIV-related mortality rate at Day 35
j. All-cause mortality rate at Day 35
Safety Endpoints(For All Subjects):
a. Adverse Events (AEs)
b. Serious Adverse Events (SAEs)
c. Treatment Emergent Adverse Events (TEAEs)
d. Treatment Emergent Serious Adverse Events (TESAEs)
e. Adverse Events of Special Interest (AEOSI) – Cohort 1 only
f. Changes in the following assessments:
i Physical examination
ii Vital signs
iii Laboratory parameters (hematology and blood chemistry)
Exploratory Endpoints
The exploratory endpoints include, but not limited to, the assessment of:
Will include, but are not limited to:
a. Pulmonary function tests
b. Pharmacokinetic analysis in DAS181 compared to placebo
c. To evaluate duration of ICU stay during initial admission
d. Viral load over time as measured by NPS collected on Study Days 1, 2, 4, 7, 10, 14, 21, 28,
and 35
e. Viral shedding
f. Anti-drug antibodies identified via ELISA on samples taken at baseline, Day 7, Day 14, and
Day 28 in DAS181
g. Drug resistance, as assessed by genotypic and/or phenotypic changes in the virus between
baseline and Day 28
h. Change in bacterial flora, as identified from bacterial throat swabs, over time from baseline
through Day 28
i. Number and frequency of subjects who require supplemental oxygen use after being assessed
as RTRA
j. All Cohort 1 efficacy endpoints assessed for Cohort 2
Note: For subjects with a pre-PIV need for oxygen, the RTRA analyses will instead be
performed to assess their return to baseline respiratory status (prior to infection)
Percent of subjects who ‘Return to Room Air’ by Day 28 (RTRA28).
Secondary Efficacy Endpoints(Cohort 1)
a. All-cause mortality rate at Day 28
b. Percent of subjects who RTRA by Day 21
c. Time (in days) to cessation of oxygen support
d. Percent of subjects who achieve CS by Day 28
e. Percent of subjects discharged (without mortality and hospice) by Day 14, 21, 28 and 35
f. Time (in days) to first hospital discharge (without hospice)
g. Total number of inpatients days (up to Day 35)
h. PIV-related mortality rate at Day 28
i. PIV-related mortality rate at Day 35
j. All-cause mortality rate at Day 35
Safety Endpoints(For All Subjects):
a. Adverse Events (AEs)
b. Serious Adverse Events (SAEs)
c. Treatment Emergent Adverse Events (TEAEs)
d. Treatment Emergent Serious Adverse Events (TESAEs)
e. Adverse Events of Special Interest (AEOSI) – Cohort 1 only
f. Changes in the following assessments:
i Physical examination
ii Vital signs
iii Laboratory parameters (hematology and blood chemistry)
Exploratory Endpoints
The exploratory endpoints include, but not limited to, the assessment of:
Will include, but are not limited to:
a. Pulmonary function tests
b. Pharmacokinetic analysis in DAS181 compared to placebo
c. To evaluate duration of ICU stay during initial admission
d. Viral load over time as measured by NPS collected on Study Days 1, 2, 4, 7, 10, 14, 21, 28,
and 35
e. Viral shedding
f. Anti-drug antibodies identified via ELISA on samples taken at baseline, Day 7, Day 14, and
Day 28 in DAS181
g. Drug resistance, as assessed by genotypic and/or phenotypic changes in the virus between
baseline and Day 28
h. Change in bacterial flora, as identified from bacterial throat swabs, over time from baseline
through Day 28
i. Number and frequency of subjects who require supplemental oxygen use after being assessed
as RTRA
j. All Cohort 1 efficacy endpoints assessed for Cohort 2
Note: For subjects with a pre-PIV need for oxygen, the RTRA analyses will instead be
performed to assess their return to baseline respiratory status (prior to infection)
Inclution Criteria
Inclusion Criteria:
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
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
Exclusion Criteria
Exclusion Criteria:
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
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
The Estimated Number of Participants
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Taiwan
8 participants
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Global
150 participants
