Actively Recruiting
An Open-Label Study to Assess Safety and Efficacy of Remdesivir for Upper Respiratory Tract RSV Infection in Patients Receiving Cellular or Bispecific Antibody Therapies
Led by Fred Hutchinson Cancer Center · Updated on 2026-06-03
60
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating how well remdesivir works to treat upper respiratory tract infection caused by respiratory syncytial virus (RSV) in patients with weakened immune systems due to cellular or bispecific antibody therapies. These therapies suppress the immune system, increasing the risk of infections like RSV, which can lead to serious pneumonia or death. This is a phase II open-label trial focused on understanding the safety and efficacy of remdesivir in this vulnerable group. Participants receive remdesivir through an intravenous (IV) infusion lasting 30 to 120 minutes daily for 5 days. Treatment may be extended up to 10 days if the doctor feels it is necessary and the disease is not worsening or causing unacceptable side effects. Throughout the study, patients undergo nasal swabs and blood sample collections to monitor the infection and treatment effects. After the treatment period, participants are followed up on days 14 and 29 to assess outcomes. Researchers measure the proportion of participants needing increased oxygen support and monitor side effects, hospitalizations, lung changes, and viral load changes from nasal swabs. Patient symptoms and respiratory impact are tracked using questionnaires. Safety is closely observed up to day 29 to evaluate the overall response to remdesivir.
CONDITIONS
Brief 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...
- Age 18 years or older
- Willing and able to provide written informed consent or have a legal representative do so
- RSV confirmed by local lab testing within 5 days before first remdesivir dose
- Symptomatic upper respiratory RSV infection with symptom onset and positive test within 5 days before treatment
- Receiving treatment for relapsed or refractory hematologic malignancy or received hematopoietic cell transplant, CAR T-cell therapy, or bispecific antibody therapy within past 365 days
- Classified as moderate or high risk per Immunodeficiency Scoring Index for RSV
- Oxygen saturation of 93% or higher on room air at rest after resting for at least 2 minutes
- Willing to take study drug and complete study procedures
- Participants of childbearing potential agree to use protocol-specified contraception methods
You will not qualify if you...
- Received or receiving approved or investigational antiviral therapies against RSV within 7 days or expected to during study
- Received investigational or off-label anti-RSV monoclonal antibodies within 4 months or expected to during study
- Received RSV vaccine after cellular therapy or current antitumor treatment start
- Participating in other experimental RSV treatment trials
- Alanine aminotransferase (ALT) levels 5 times above normal within 7 days before screening
- Unable to tolerate nasal sampling needed for study
- Life expectancy of 3 months or less
- Pregnant within 7 days before screening
- Requiring supplemental oxygen or oxygen saturation below 93% at rest within 24 hours before treatment
- Recent RSV or other respiratory viral infection or hospitalization within 28 days before screening
- Positive test for other respiratory viruses within 7 days before screening
- Untreated or uncontrolled bacteremia, fungemia, or pneumonia within recent weeks
- Uncontrolled symptoms of cytokine release syndrome or neurotoxicity within 72 hours before screening
- Any condition preventing study drug intake or procedure compliance
- Known allergy to remdesivir or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days
Participants receive remdesivir intravenously over 30-120 minutes on days 1-5, with the option to extend to day 10 at the investigator's discretion if there is no disease progression or unacceptable toxicity. Participants also undergo nasal swabs and blood sample collection throughout this period.
Daily visits for up to 10 days
Duration - Up to 24 days after treatment ends
After completing treatment, participants are followed up to monitor safety and efficacy outcomes.
2 visits (in-person) on day 14 and day 29
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
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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