An Open-Label Study to Assess the Safety and Efficacy of Remdesivir for Treatment of Symptomatic Laboratory-Confirmed Respiratory Syncytial Virus Infection of the Upper Respiratory Tract in Patients Receiving Cellular or Bispecific Antibody Therapies

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• Have one of the following underlying diseases and/or received one of the following treatments relative to RSV diagnosis date:

‣ Received allogeneic hematopoietic cell transplant (HCT) with any conditioning regimen within 1 year

⁃ Received autologous HCT with any conditioning regimen within 3 months

⁃ Received Chimeric antigen receptor T cell therapy (CARTx) within 3 months

⁃ Have multiple myeloma (MM) and received bispecific antibody therapy (bsAb) within 3 months

⁃ Have lymphoma and received bsAb within 3 months

• Categorized as moderate-risk (overall score 3-6) or high-risk (overall score 7-12) 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) 92% 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 ≥ 92%) 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

Locations
United States
California
City of Hope Comprehensive Cancer Center
NOT_YET_RECRUITING
Duarte
Texas
MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
Joshua Hill, MD
Jahill3@fredhutch.org
206-667-6504
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Treatment (remdesivir)
Patients receive remdesivir IV over 30-120 minutes on days 1-5, with the option to extend to day 10 at the investigator's discretion, in the absence of disease progression or unacceptable toxicity. Patients also undergo nasal swabs and blood sample collection throughout the study.
Sponsors
Leads: Fred Hutchinson Cancer Center
Collaborators: Gilead Sciences

This content was sourced from clinicaltrials.gov