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 3-agent immunosuppression regimen that includes a steroid, a calcineurininhibitor (CNI), and cell cycle inhibitor (e.g., mycophenolate, azathioprine) >4weeks 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) <14 days prior to the baselinevisit.
Currently using an mTOR inhibitor or azathioprine
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 bronchial stents or cryotherapy within 12 months of the Screening Visit
Study Design
Connect with a study center
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United StatesActive - Recruiting
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 StatesActive - Recruiting
University of California San Diego Health
San Diego, California 92103
United StatesActive - Recruiting
University of California at San Diego
San Diego, California 92103
United StatesSite Not Available
Advent Health
Orlando, Florida 32803
United StatesActive - Recruiting
Adventist Health
Orlando, Florida 32803
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
University of South Florida - Tampa General Hospital
Tampa, Florida 33606
United StatesActive - Recruiting
University of Iowa Hospital
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
University of Minnesota Medical School
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 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 StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio 43221
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio 43221
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29452
United StatesActive - Recruiting
Baylor Scott and White Research Institute
Dallas, Texas 75246
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 45390
United StatesActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
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