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

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 clinical trial is studying a drug called DAS181, a drug called DAS181 COVID-19, and others for people with covid-19, immunocompromised, and other related conditions. The study is currently recruiting participants at 67 locations.

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(28)

City of Hope cancer Center

Duarte, California, United States

University of California Davis Health System

Sacramento, California, United States

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

Chicago, Illinois, United States

University of Iowa Health Care

Iowa City, Iowa, United States

University of Kansas Medical Center

Fairway, Kansas, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Weill Cornell Medical College

New York, New York, United States

Duke University

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

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

Froedtert Medical College Pulmonary Clinic

Milwaukee, Wisconsin, United States

Westmead Hospital

Sydney, New South Wales, Australia

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, China

Seoul National University Hospital

Seoul, Gyeonggi-do, South Korea

Samsung Medical Center

Seoul, Gyeonggi-do, South Korea

National Cheng Kung University Hospital

Tainan, Tainan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT03808922


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