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.
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)
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
Single group
Remdesivir
DrugGiven IV
Survey Administration
Other interventionAncillary studies
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Nasal Swab
Procedure/SurgeryUndergo nasal swabs
Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hours
Will be estimated with 95% Wilson confidence intervals.
Incidence of treatment-emergent adverse events (AEs) and laboratory abnormalities
Will consider using time-to-event methods such as cumulative incidence curves and Cox proportional hazards regression.
Incidence of serious adverse events and AEs leading to study drug discontinuation
Will consider using time-to-event methods such as cumulative incidence curves and Cox proportional hazards regression.
Proportion of participants with RSV-related hospitalization (if not hospitalized at the time of first dose) or death
Will consider using time-to-event methods such as cumulative incidence curves and Cox proportional hazards regression.
Supplemental oxygen free days
Defined as days alive and not requiring ≥ 2 liters/minute of supplemental oxygen. Will be compared between cohorts using weighted least squares linear regression with propensity score weights.
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Fred Hutchinson Cancer Center
Lead sponsor
Gilead Sciences
Collaborator
