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Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals

StatusRecruiting
PhasePhase 2
Started2025-12-23
View on ClinicalTrials.gov ↗

Amendment history

2026-08-05
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 3 sites
2026-06-01
Study Status, Eligibility v11
Eligibility criteria-314 characters
[...] ic lung disease, chronic rhinorrhea, or seasonal allergies) HaveReceiving treatment for a refractory or relapsed hematologic malignancy, and/or autoimmune disease and received one of the following treatments relative to RSV diagnosis date: Received allogeneica hematopoietic cell transplant (HCT), with any conditioning regimen within 1 year Received autologous HCT with any conditioning regimen within 3 months Received Chimericchimeric antigen receptor T cell therapy (CARTx), within 3 months Receivedor bispecific antibody therapy (bsAb) therapy within 3the monthspast 365 days (relative to RSV di [...] [...]
2026-02-26
Study Status, Eligibility v10
Eligibility criteria-37 characters
[...] hours prior to study drug administration Previous infection and/or hospitalizationtreatment for RSV, or previous infection with, treatment for, or hospitalization for another respiratory viral infection, within< 28 days prior tobefore screening Documented positive test for other respiratory vi [...]
2025-12-23
Study Status, Conditions, Eligibility v9
Start dateestimated 2026-01-17→confirmed 2025-12-23
Eligibility criteria-51 characters
[...] ng disease, chronic rhinorrhea, or seasonal allergies) Have onea ofhematologic the following underlying diseasesmalignancy and/or autoimmune disease and received one of the following treatments relative to RSV di [...] ric antigen receptor T cell therapy (CARTx) within 3 months Have multiple myeloma (MM) and receivedReceived 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 7-1210) per an adapted version of the Immunodeficiency Scoring Ind [...] 0 cells/µL within the prior 7 days Oxy [...]
2025-12-17
Study Status, Contacts/Locations v8
Start date2025-12-17→2026-01-17
Study sitesdetails revised at 1 of 3 sites
Show 7 earlier versions
2025-11-17
Study Status v7
Start date2025-11-15→2025-12-17
2025-10-17
Study Status v6
Start date2025-10-15→2025-11-15
2025-09-24
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2025-10-01→2025-10-15
Study sitesdetails revised at 3 of 3 sites
2025-08-08
Study Status v4
Start date2025-08-01→2025-10-01
2025-07-10
Study Status, Eligibility v3
Eligibility criteria+460 characters
[...] 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 Criteria: Received or receiving an approved or aut [...] 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 antivir [...] SV for the current RSV episode Received any investigational anti-RSV m [...] [...]
2025-06-11
Study Status v2
Re-verified, no change to tracked fields
2025-02-07
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 10 entries
2025-02-05
Original filing
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.
Trial Details
NCT Number NCT06817889
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Gilead Sciences
Conditions Hematopoietic and Lymphatic System Neoplasm, Autoimmune Disease, Respiratory Syncytial Virus Infection
Enrollment 60 participants
Start Date 2025-12-23
Primary Completion 2027-11-30 (estimated)
Study Completion 2027-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-10-01