RecruitingPhase 3NCT03808922

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

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

Sponsor

Ansun Biopharma, Inc.

Enrollment

274 participants

Start Date

May 23, 2019

Study Type

INTERVENTIONAL

Conditions

COVID-19 Lower Respiratory Tract Infection Immunocompromised Parainfluenza

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This Phase III trial is testing an inhaled antiviral drug called DAS181 for immunocompromised patients who develop lower respiratory tract infections (LRTIs) from certain viruses, including parainfluenza. The study also includes a sub-study specifically for COVID-19 patients. Immunocompromised patients — such as those who have had transplants or chemotherapy — are especially vulnerable to these infections. You may be eligible if: - You are immunocompromised (transplant recipient, chemotherapy patient, or have congenital immune deficiency) - You need supplemental oxygen (at least 2 liters per minute) due to low oxygen levels - You have a confirmed lower respiratory tract infection with a sialic acid-dependent respiratory virus within the past 3 days - For the COVID-19 sub-study: you are 18 or older, have CT-confirmed lung involvement in at least 2 lobes, and have lab-confirmed SARS-CoV-2 You may NOT be eligible if: - You are on hospice care or have very low survival probability in the first 10 days - Your liver tests (ALT, AST, or ALP) are significantly elevated alongside high bilirubin - You are breastfeeding or pregnant - You are taking another investigational drug for a pulmonary infection - You have severe sepsis with organ failure outside the lungs or need vasopressors - For COVID-19: you require mechanical ventilation, BiPAP, or CPAP at enrollment Talk to your doctor about your immune status, current medications, and oxygen requirements before applying.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDAS181

DAS181 4.5mg nebulized qd x 7 OR 10 days

DRUGPlacebo

Placebo nebulized qd x 7 OR 10 days

DRUGDAS181 COVID-19

DAS181 4.5mg nebulized q12h/day x 7 OR 10 days

DRUGDAS181 OL

DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg

Locations(67)

City of Hope cancer Center

Duarte, California, United States

UCLA

Los Angeles, California, United States

University of California Davis Health System

Sacramento, California, United States

University of California San Diego Medical Center

San Diego, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Sylvester Comprehensive Cancer Center, University of Miami Health System

Miami, Florida, United States

Houston Methodist Hospital

Tampa, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Iowa Health Care

Iowa City, Iowa, United States

University of Kansas Medical Center

Fairway, Kansas, United States

Louisiana State University

Shreveport, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Universtiy of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Duke University

Durham, North Carolina, United States

Novant Health

Winston-Salem, North Carolina, United States

The Lindner Center- The Christ Hospital

Cincinnati, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

Kent Hospital

Warwick, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Cook Children's

Forth Worth, Texas, United States

Texas Health

Forth Worth, Texas, United States

Therapeutic Concepts

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

MD Anderson

Houston, Texas, United States

VCU Health System

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Froedtert Medical College Pulmonary Clinic

Milwaukee, Wisconsin, United States

Westmead Hospital

Sydney, New South Wales, Australia

The Wesley Hospital

Auchenflower, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, 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

Rigshospitalet

Copenhagen, Denmark

Hôpital Henri Mondor

Créteil, Île-de-France Region, France

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Gyeonggi-do, South Korea

Asan Medical Center

Seoul, Gyeonggi-do, South Korea

Samsung Medical Center

Seoul, Gyeonggi-do, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Gyeonggi-do, South Korea

National Cheng Kung University Hospital

Tainan, Tainan, Taiwan

National Taiwan University Hospital

Zhongzheng, Taipei City, Taiwan

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