Remdesivir for RSV in Immunocompromised Individuals
This study is testing remdesivir, an antiviral medication, for treating respiratory syncytial virus (RSV) infections in the upper airway. It's for adults (18 and older) who have weakened immune systems due to certain cancer treatments (cellular or bispecific antibody therapy) and have a confirmed RSV infection. The study aims to see if remdesivir can prevent participants from needing significant oxygen support (at least 2 liters per minute for 24 hours) up to 29 days after starting treatment. RSV can be serious for people with weakened immune systems, and remdesivir works by stopping the virus from spreading. The study plans to enroll 60 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive remdesivir intravenously for 5-10 days. You would also have nasal swabs and blood samples collected throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, participants are followed up on day 14 and day 29.
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NCT06817889
Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
Recruiting
PHASE2Ages 18+InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~60 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:RemdesivirSurvey AdministrationBiospecimen CollectionNasal Swab
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hours
Measured over Up to day 29
Conditions
Where it's being run
3 sites across 3 statesCalifornia1
Texas1
Washington1
Study leadership
- Joshua Hill, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Aged ≥ 18 years
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)
RSV confirmed by local lab testing via nucleic acid amplification test (e.g. polymerase chain reaction \[PCR\] or respiratory viral panel \[RVP\]) using an upper respiratory tract sample collected within the 5 days prior to day 1 (RDV dosing)
Symptomatic RSV infection of the upper respiratory tract, with symptom onset and positive microbiologic testing within the 5 days prior to day 1 (RDV dosing). Symptomatic RSV infection is defined as having new upper respiratory symptom(s) or worsening of a pre-existing upper respiratory symptom (if chronic and associated with a previously existing diagnosis, such as chronic lung disease, chronic rhinorrhea, or seasonal allergies)
Receiving treatment for a refractory or relapsed hematologic malignancy, or received a hematopoietic cell transplant (HCT), chimeric antigen receptor T cell therapy (CARTx), or bispecific antibody (bsAb) therapy within the past 365 days (relative to RSV diagnosis date)
Categorized as moderate-risk (overall score 3-6) or high-risk (overall score 7-10) per an adapted version of the Immunodeficiency Scoring Index (ISI) for RSV, as below, relative to the day of RSV diagnosis:
1 point:
Recent (within the prior 30 days) allogeneic HCT, autologous HCT, or CARTx
Corticosteroids within the prior 30 days for management of graft versus host disease (GVHD) or cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
2 points:
Age ≥ 40 years
3 points:
Absolute neutrophil count (ANC) \< 500 cells/μL within the prior 7 days
Absolute lymphocyte count (ALC) \< 200 cells/µL within the prior 7 days
Oxygen saturation (SpO2) 93% or greater on room air and at rest (to be measured after participant has rested in a quiet room for ≥ 2 minutes, with oxygen \[O2\] saturation probe on finger or earlobe for ≥ 1 minute, with saturation reading remaining ≥ 93%) at screening
Willingness to take study drug and complete necessary study procedures
Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described
Exclusion
Received or receiving an approved or authorized direct-acting antiviral therapy with potential efficacy against RSV (e.g. ribavirin) for ≥ 24 hours within the prior 7 days, and/or expected to receive anti-RSV direct-acting antiviral therapies for RSV during the course of the study at the time of screening
Received or receiving investigational direct-acting antiviral therapies against RSV for the current RSV episode
Received any investigational anti-RSV monoclonal antibodies or off-label use of approved anti-RSV monoclonal antibodies within \< 4 months or \< 5 half-lives, whichever is longer, before screening, or expected to receive anti-RSV monoclonal antibodies during the course of the study at the time of screening
Received an RSV vaccine after cellular therapy or after starting the current antitumor therapeutic regimen
Participation in any other concurrent clinical trial of an experimental treatment for RSV, including RSV vaccines
Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal within 7 days prior to screening
Unable to tolerate nasal sampling required for this study, as determined by the investigator (e.g., history of significant epistaxis, nasopharyngeal anatomical abnormalities, nasal or sinus surgery)
A life expectancy of three months or less, as determined by the investigator
Pregnant, as determined by a Point-of-Care urine pregnancy test or reported by the patient or their electronic health record within 7 days of screening
Receiving, requiring, or expected to require supplemental oxygen for RSV-related illness or SpO2 \< 93% at rest \< 24 hours prior to study drug administration
Previous infection or treatment for RSV, or previous treatment or hospitalization for another respiratory viral infection, \< 28 days before screening
Documented positive test for other respiratory viruses concomitantly (limited to influenza, parainfluenza, adenovirus, human metapneumovirus, or coronavirus \[including SARS-CoV-2\]) ≤ 7 days prior to screening, as determined by local testing (additional testing not required)
Clinically significant bacteremia or fungemia ≤ 7 days prior to screening and not adequately treated, as determined by the investigator
Clinically significant bacterial, fungal, or viral pneumonia within two (2) weeks prior to screening and not adequately treated, as determined by the investigator
Clinically significant symptoms of CRS or ICANS within the prior 72 hours before screening that is not adequately controlled, as determined by the investigator
Any inability to take study drug or comply with study procedures that, in the opinion of the investigator, would make the participant unsuitable for the study
Known hypersensitivity or allergy to the study drug, its metabolites, or formulation excipients
What this trial measures
- Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hoursUp to day 29
Will be estimated with 95% Wilson confidence intervals.