Actively Recruiting
Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-27
60
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well remdesivir works for treatment of respiratory syncytial virus (RSV) infection of the upper respiratory tract in patients receiving cellular or bispecific antibody therapy. Cellular or bispecific antibody therapies cause suppression of the immune system, making infections more frequent and reducing the body's ability to fight the infections. RSV infections are one of the most common respiratory infections in immunocompromised individuals and can cause significant pneumonia and even death. Remdesivir is in a class of medications called antivirals. It works by stopping viruses from spreading in the body.
CONDITIONS
Official Title
Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years
- Willing and able to provide written informed consent, or have a legal representative who can provide consent
- RSV infection confirmed by local lab testing within 5 days before treatment
- Symptomatic RSV infection of the upper respiratory tract with symptom onset and positive test within 5 days before treatment
- Have hematologic malignancy and/or autoimmune disease and received cellular or bispecific antibody therapy within specified recent timeframes
- Categorized as moderate- or high-risk based on an adapted Immunodeficiency Scoring Index for RSV
- Oxygen saturation at rest of 93% or greater on room air measured after rest
- Willingness to take study drug and complete necessary study procedures
- Participants of childbearing potential must agree to use specified contraception methods if engaging in heterosexual intercourse
You will not qualify if you...
- Received or currently receiving approved or investigational antiviral therapies for RSV recently or expected during the study
- Received investigational or off-label anti-RSV monoclonal antibodies within 4 months or 5 half-lives before screening
- Received RSV vaccine after cellular therapy or starting current antitumor treatment
- Participation in other clinical trials for RSV treatments
- Alanine aminotransferase (ALT) 5 times or more above normal within 7 days before screening
- New lower respiratory tract abnormalities or symptoms suspected due to RSV
- Unable to tolerate nasal sampling required for the study
- Life expectancy 3 months or less
- Pregnant within 7 days before screening
- Receiving or expected to require supplemental oxygen or oxygen saturation below 93% at rest within 24 hours before study drug
- Recent infection or treatment for RSV or other respiratory viral infections within 28 days before screening
- Positive test for other respiratory viruses within 7 days before screening
- Clinically significant untreated bacteremia, fungemia, or pneumonia within specified recent timeframes
- Significant symptoms of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome within 72 hours before screening
- Any inability to take study drug or comply with study procedures
- Known allergy or hypersensitivity to the study drug or its components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Not Yet Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
J
Joshua Hill, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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