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New treatment option for Lower Respiratory Tract Infection
Official title Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
ClinicalTrials.gov ID: NCT03808922
What this study is testing
What is DAS181?
DAS181 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for lower respiratory tract infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
You likely can't join if
- people 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
- people with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x...
- Female people breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
- people 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...
- people with known hypersensitivity to DAS181 and/or any of its components
See the full eligibility 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 people age \< 18 years old) or pre-term birth (only applicable to people 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 For COVID-19 sub study:
- Be ≥18 years of age
- Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
- Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
- Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
- Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
- Satisfy #1, 4, 5, 6, 7 of the main study
- people 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
- people with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: people with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have...
- Female people breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
- people 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
- people with known hypersensitivity to DAS181 and/or any of its components
- people 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:
- people requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
- people 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).
- people who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
- people who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
- people 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
- people meeting exclusion criteria #2, 3, 5 and 6 of the main study
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Sacramento, California, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Fairway, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Sacramento, California, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States; Fairway, Kansas, United States; Baltimore, Maryland, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.