COVID-19 Clinical Trial
Official 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
Verified date | July 2023 |
Source | Ansun Biopharma, Inc. |
Contact | Lisa Li |
Phone | 858-353-4948 |
lli[@]ansunbiopharma.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ansun Biopharma, Inc. |
United States, Australia, China, Denmark, France, Hong Kong, Korea, Republic of, Taiwan,
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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