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Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

Purpose

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.

Conditions

Lower Respiratory Tract Infection
Parainfluenza
Immunocompromised
COVID-19

Eligibility

Eligible Ages: All ages
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1 and Cohort 2 Treatment	DAS181 4.5mg qd x 7 OR 10 days	Drug: DAS181 DAS181 4.5mg nebulized qd x 7 OR 10 days
Placebo Comparator Cohort 1 and Cohort 2 Placebo	Placebo qd x 7 OR 10 days	Drug: Placebo Placebo nebulized qd x 7 OR 10 days
Experimental Cohort 3	DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)	Drug: DAS181 OL DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg
Experimental Cohort 4	DAS181 4.5mg qd x 7 OR 10 days	Drug: DAS181 OL DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg
Experimental DAS181 COVID-19 Treatment	DAS181 4.5mg q12h x 7 OR 10 days	Drug: DAS181 COVID-19 DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
Placebo Comparator DAS181 COVID-19 Placebo	Placebo q12h x 7 OR 10 days	Drug: Placebo Placebo nebulized qd x 7 OR 10 days

Recruiting Locations

City of Hope cancer Center
Duarte 5344147, California 5332921 91010

University of California Davis Health System
Sacramento 5389489, California 5332921 95817

Contact:
Stuart Cohen, MD

Sylvester Comprehensive Cancer Center, University of Miami Health System
Miami 4164138, Florida 4155751 33136

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611

University of Iowa Health Care
Iowa City 4862034, Iowa 4862182 52242

University of Kansas Medical Center
Fairway 4271358, Kansas 4273857 66205

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905

Weill Cornell Medical College
New York 5128581, New York 5128638 10065

Contact:
Rosypriya Kodiyanplakkal, MD

Duke University
Durham 4464368, North Carolina 4482348 27710

Contact:
Cameron Wolfe, MD

Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45267

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104

University of Pittsburgh Medical Center Health System
Pittsburgh 5206379, Pennsylvania 6254927 15213

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

Baylor College of Medicine
Houston 4699066, Texas 4736286 77030

MD Anderson
Houston 4699066, Texas 4736286 77030

VCU Health System
Richmond 4781708, Virginia 6254928 23298

Contact:
Kristin Miller, MD

Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

Froedtert Medical College Pulmonary Clinic
Milwaukee 5263045, Wisconsin 5279468 53266

Contact:
Jonathon Truwit, MD

More Details

NCT ID: NCT03808922
Status: Recruiting
Sponsor: Ansun Biopharma, Inc.

Study Contact

Lisa Li
858-353-4948
lli@ansunbiopharma.com

Detailed 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.