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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03808922




Registration number
NCT03808922
Ethics application status
Date submitted
16/01/2019
Date registered
18/01/2019
Date last updated
17/04/2020

Titles & IDs
Public title
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
Scientific title
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
Secondary ID [1] 0 0
2018-004318-16
Secondary ID [2] 0 0
DAS181-3-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Respiratory Tract Infection 0 0
Parainfluenza 0 0
Immunocompromised 0 0
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DAS181
Treatment: Drugs - Placebo
Treatment: Drugs - DAS181 COVID-19
Treatment: Drugs - DAS181 OL

Experimental: DAS181 - DAS181 4.5mg qd x 7 OR 10 days

Placebo Comparator: Placebo - Placebo qd x 7 OR 10 days

Experimental: DAS181 OL - DAS181 4.5mg qd x 7 OR 10 days (= 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)

Experimental: DAS181 COVID-19 - DAS181 4.5mg q12h x 7 OR 10 days


Treatment: Drugs: DAS181
DAS181 4.5mg nebulized qd x 7 OR 10 days

Treatment: Drugs: Placebo
Placebo nebulized qd x 7 OR 10 days

Treatment: Drugs: DAS181 COVID-19
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days

Treatment: Drugs: DAS181 OL
DAS181 4.5mg nebulized qd x 7 OR 10 days = 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of subjects who Return to Room Air (RTRA) (main study) - Removal of all oxygen support (with stable SpO2)
Timepoint [1] 0 0
by Day 28
Primary outcome [2] 0 0
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
Timepoint [2] 0 0
Day 14
Secondary outcome [1] 0 0
All-cause mortality rate (main study)
Timepoint [1] 0 0
at Day 28
Secondary outcome [2] 0 0
Percent of subjects who Return to Room Air (RTRA) (main study)
Timepoint [2] 0 0
by Day 21
Secondary outcome [3] 0 0
Time (in days) to RTRA (main study)
Timepoint [3] 0 0
Days 10, 14, 21, 28
Secondary outcome [4] 0 0
Percent of subjects who achieve clinical stability (main study)
Timepoint [4] 0 0
by Day 28
Secondary outcome [5] 0 0
Percent of subjects discharged (without mortality and hospice) (main study)
Timepoint [5] 0 0
by Days 14, 21, 28 and 35
Secondary outcome [6] 0 0
Time (in days) to first hospital discharge (without hospice) (main study)
Timepoint [6] 0 0
through Day 35
Secondary outcome [7] 0 0
Total number of inpatient days (main study)
Timepoint [7] 0 0
up to Day 35
Secondary outcome [8] 0 0
Baseline SAD-RV infection-related mortality rate (main study)
Timepoint [8] 0 0
at Day 28
Secondary outcome [9] 0 0
Baseline SAD-RV infection-related mortality rate (main study)
Timepoint [9] 0 0
at Day 35
Secondary outcome [10] 0 0
All-cause mortality rate (main study)
Timepoint [10] 0 0
at Day 35
Secondary outcome [11] 0 0
Change in pulmonary function (FEV1% predicted) (main study)
Timepoint [11] 0 0
Day 1, Day 7, Day 14, Day 28
Secondary outcome [12] 0 0
Time to improved COVID19 clinical status (Sub-study)
Timepoint [12] 0 0
Day 5, Day 10, Day 21, Day 28
Secondary outcome [13] 0 0
Time to RTRA
Timepoint [13] 0 0
Day 10, Day 14, Day 21, Day 28
Secondary outcome [14] 0 0
Time to Clinical stability
Timepoint [14] 0 0
Day 14, Day 21, Day 28
Secondary outcome [15] 0 0
Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Timepoint [15] 0 0
Day 5, Day 10, Day 14, Day 21, Day 28
Secondary outcome [16] 0 0
Time to Clinical deterioration
Timepoint [16] 0 0
Day 5, Day 10, Day 14, Day 21, Day 28
Secondary outcome [17] 0 0
Time to Discharge from hospital (without readmission before Day 28).
Timepoint [17] 0 0
Day 14, Day 21, Day 28
Secondary outcome [18] 0 0
Time to Death (all causes)
Timepoint [18] 0 0
Day 14, Day 21, Day 28

Eligibility
Key inclusion criteria
1. At the time of randomization, requires supplemental oxygen =2 LPM due to hypoxemia.

2. 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)

3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid
dependent respiratory virus

4. 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

5. Non-vasectomized males are required to practice effective birth control methods

6. Capable of understanding and complying with procedures as outlined in the protocol

7. Provides signed informed consent prior to the initiation of any screening or
study-specific procedures

For COVID-19 sub study:

1. Be =18 years of age

2. Provide adequate medical history to permit accurate stratification (but health status
may be healthy, high-risk conditions, or immunocompromised).

3. Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of
daily living (basic ADL)

4. Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without
contrast, to involve at least 2 lobes of the lung.

5. Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by
at least one of the following samples

6. Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 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

3. Female subjects breastfeeding or planning to breastfeed at any time through 30 days
after the last dose of study drug

4. Subjects taking any other investigational drug used to treat pulmonary infection.

5. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion
of the principal investigator, would affect subject safety and/or compliance

6. Subjects with known hypersensitivity to DAS181 and/or any of its components

7. 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:

1. Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.

2. 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).

3. Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA
assessment)

4. Subjects who are currently taking immunomodulating biologics (e.g, interferons,
interleukin)

5. 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

6. Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
The Wesley Hospital - Brisbane
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
4066 - Brisbane
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Guenoggi-do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ansun Biopharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03808922
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stanley Lewis, M.D
Address 0 0
Ansun Biopharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Ho, M.D
Address 0 0
Country 0 0
Phone 0 0
858-452-2631
Fax 0 0
Email 0 0
jho@ansunbiopharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03808922