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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03808922
Other study ID # DAS181-3-01
Secondary ID 2018-004318-16
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 23, 2019
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source Ansun Biopharma, Inc.
Contact Lisa Li
Phone 858-353-4948
Email lli@ansunbiopharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 ≥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) Cohort 2: 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. Cohort 3: 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. Cohort 4: 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. Sub-Study: Patients with Severe COVID-19


Recruitment information / eligibility

Status Recruiting
Enrollment 274
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 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


Intervention

Drug:
DAS181
DAS181 4.5mg nebulized qd x 7 OR 10 days
Placebo
Placebo nebulized qd x 7 OR 10 days
DAS181 COVID-19
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
DAS181 OL
DAS181 4.5mg nebulized qd x 7 OR 10 days = 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg

Locations

Country Name City State
Australia The Wesley Hospital Auchenflower Queensland
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Royal Melbourne Hospital Melbourne Victoria
Australia Westmead Hospital Sydney New South Wales
China West China Hospital Chengdu Sichuan
China Shulan (Hangzhou) Hospital co., LTD Hangzhou Zhejiang
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
China Shanghai Pulmonary Hospital Yangpu Shanghai
Denmark Rigshospitalet Copenhagen
France Hôpital Henri Mondor Créteil Ile-de-France
Hong Kong Prince of Wales Hospital Sha Tin New Territories
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul Gyeonggi-do
Korea, Republic of Samsung Medical Center Seoul Gyeonggi-do
Korea, Republic of Seoul National University Hospital Seoul Gyeonggi-do
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Gyeonggi-do
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Zhongzheng Taipei City
United States Universtiy of Michigan Ann Arbor Michigan
United States Children's Hospital Colorado Aurora Colorado
United States The Johns Hopkins Hospital Baltimore Maryland
United States University of Maryland Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States University of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States The Lindner Center- The Christ Hospital Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio
United States The Cleveland Clinic Foundation Cleveland Ohio
United States City of Hope cancer Center Duarte California
United States Duke University Durham North Carolina
United States University of Kansas Medical Center Fairway Kansas
United States Cook Children's Fort Worth Texas
United States Texas Health Fort Worth Texas
United States Baylor College of Medicine Houston Texas
United States MD Anderson Houston Texas
United States Therapeutic Concepts Houston Texas
United States UCLA Los Angeles California
United States Loyola University Medical Center Maywood Illinois
United States Froedtert Medical College Pulmonary Clinic Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Vanderbilt University Medical Center Nashville Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States Weill Cornell Medical College New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Health System Pittsburgh Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States VCU Health System Richmond Virginia
United States Mayo Clinic Rochester Rochester Minnesota
United States University of California Davis Health System Sacramento California
United States Washington University Saint Louis Missouri
United States University of California San Diego Medical Center San Diego California
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Seattle Children's Hospital Seattle Washington
United States Louisiana State University Shreveport Louisiana
United States Kent Hospital Warwick Rhode Island
United States Novant Health Winston-Salem North Carolina
United States St. Elizabeth Youngstown Hospital Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ansun Biopharma, Inc.

Countries where clinical trial is conducted

United States,  Australia,  China,  Denmark,  France,  Hong Kong,  Korea, Republic of,  Taiwan, 

Outcome

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