Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Bronchitis (Pediatric)
Treatment
ARINA-1
Standard of care only
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Bilateral lung transplant >12 months from the time of Visit 1 / Randomization
Age 18-75 years old at the time of consent
Routinely followed at enrolling site
Willing and able to comply with visit schedule and at-home requirements
10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months.
Capable of giving informed consent
On a stable maintenance regimen of azithromycin for >4 weeks prior to the ScreeningVisit
On a stable 2-agent or 3-agent immunosuppression regimen that includes a steroid, acalcineurin inhibitor (CNI), and, optionally, a cell cycle inhibitor (e.g.,mycophenolate, azathioprine) >4 weeks prior to Screening
If a woman of childbearing potential (WOCBP), must agree to use a reliable method ofbirth control for the entire duration of the study.
Exclusion
Exclusion Criteria:
Positive urine pregnancy test at screening and baseline visit
Diagnosis of active congestive heart failure or symptomatic coronary artery disease > grade 3 based on the New York Heart Association Functional Classification (NYHA)criteria
Restrictive allograft syndrome (RAS) defined by radiographic interstitial oralveolar opacities on chest X-ray or CT scan that are consistent with RAS
Have advanced BOS, defined by >24% decrease in FEV1 in post-transplant baseline
A diagnosis of probable antibody-mediated rejection (AMR) <12 months prior to thebaseline visit
Donor-specific antibodies (DSA) identified <6 months prior to the baseline visit. *The presence of DSA >6 months from the baseline visit is acceptable for enrollmentinto the study.
Unresolved diffuse alveolar damage
Receiving mechanical ventilation
Chronic kidney disease stage IV or higher, including on dialysis
Initiating a new maintenance therapy or changing immunosuppression maintenancetherapy (e.g., changing tacrolimus to cyclosporine) <30 days prior to the baselinevisit.
Have initiated or changed mTOR maintenance therapy <3 months prior to Clinic Visit 1 (mTOR use for >3 months is allowed)
Initiating or changing antibiotic (including azithromycin), antiviral, or antifungaltherapy <14 days prior to the baseline visit.
Use of alemtuzumab <6 months prior to the baseline visit
Use of anti-thymocyte therapies (e.g., anti-thymocyte globulin) or photopheresis <90days prior to the Screening Visit. Prior use of Trikafta (elexacaftor, ivacaftor,and tezacaftor is allowed as long as the participant has been on stable dose for >90days prior to the Screening Visit.
Initiating a multivitamin or other supplement (inhaled, oral, or IV) containingvitamin C, glutathione, or N-acetylcysteine <90 days prior to the baseline visit
Significant unstable comorbidities, in the opinion of the site investigator
Allery or previous adverse reaction to azithromycin
A diagnosis of dynamic collapse / tracheobrochomalacia <90 days of the baselinevisit.
Subjects currently participating in, or who have participated in an interventional (drug or device) clinical study <30 days of the baseline visit.
Have been diagnosed with ARAD within 6 weeks of the Screening Visit.
Have used belatacept <6 months prior to Clinic Visit 1
Have had an initial treatment of bronchial stents or cryotherapy within 12 months ofthe Screening Visit, or had bronchial stents removed within the last 3 months of theScreening Visit.
Study Design
Connect with a study center
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United StatesSite Not Available
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752 85013
United StatesSite Not Available
University of California Log Angeles School of Medicine
Los Angeles, California 90095
United StatesActive - Recruiting
University of California Los Angeles (UCLA)
Los Angeles, California 90095
United StatesActive - Recruiting
University of California Los Angeles School of Medicine
Los Angeles, California 90095
United StatesSite Not Available
University of California San Diego Health
San Diego, California 92103
United StatesSite Not Available
University of California at San Diego
San Diego, California 92103
United StatesSite Not Available
University of California Los Angeles School of Medicine
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting
University of California San Diego Health
San Diego 5391811, California 5332921 92103
United StatesActive - Recruiting
Advent Health
Orlando, Florida 32803
United StatesSite Not Available
Adventist Health
Orlando, Florida 32803
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
University of South Florida - Tampa General Hospital
Tampa, Florida 33606
United StatesActive - Recruiting
Advent Health
Orlando 4167147, Florida 4155751 32803
United StatesActive - Recruiting
University of South Florida
Tampa 4174757, Florida 4155751 33606
United StatesActive - Recruiting
Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153
United StatesActive - Recruiting
University of Iowa Hospital
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospital
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
University of Minnesota Medical School
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota Medical School
Minneapolis 5037649, Minnesota 5037779 55455
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Columbia University
New York, New York 10032
United StatesActive - Recruiting
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University Wexner Medical Center
Columbus, Ohio 43221
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio 43221
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43221
United StatesActive - Recruiting
Temple University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19122
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29452
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29452
United StatesActive - Recruiting
Baylor Scott and White Research Institute
Dallas, Texas 75246
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 45390
United StatesActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
Baylor Scott and White Research Institute
Dallas 4684888, Texas 4736286 75246
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 45390
United StatesActive - Recruiting
Baylor St. Luke's Medical Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Inova Fairfax Hospital
Falls Church 4758390, Virginia 6254928 22042
United StatesActive - Recruiting

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