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

NCT06817889 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1125015NCI-2025-0057220650
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Autoimmune Disease; Respiratory Syncytial Virus Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hours

  Will be estimated with 95% Wilson confidence intervals.

  Up to day 29

Secondary Outcomes (10)

• Incidence of treatment-emergent adverse events (AEs) and laboratory abnormalities

  Up to day 29

• Incidence of serious adverse events and AEs leading to study drug discontinuation

  Up to day 29

• Proportion of participants with RSV-related hospitalization (if not hospitalized at the time of first dose) or death

  Up to day 29

• Supplemental oxygen free days

  Up to day 29

• Proportion of participants who develop new or worsening pulmonary infiltrates

  Up to day 29

Study Arms (1)

Treatment (remdesivir)

EXPERIMENTAL

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.

Drug: Remdesivir; Other: Survey Administration; Procedure: Biospecimen Collection; Procedure: Nasal Swab

Interventions

Survey Administration OTHER

Ancillary studies

Treatment (remdesivir)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (remdesivir)

Nasal Swab PROCEDURE

Undergo nasal swabs

Also known as: Nasal Swab Test, Nasopharyngeal Swab, Nasopharyngeal Swab Test

Treatment (remdesivir)

Remdesivir DRUG

Given IV

Also known as: 2-Ethylbutyl (2S)-2-(((S)-(((2R,3S,4R,5R)-5-(4-aminopyrrolo(2,1-f)(1,2,4)triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)amino)propanoate, GS-5734, L-Alanine, N-((S)-hydroxyphenoxyphosphinyl)-, 2-Ethylbutyl Ester, 6-Ester with 2-C-(4-aminopyrrolo(2,1-f)(1,2,4)triazin-7-yl)-2,5-anhydro-D-altrononitrile, RDV, SARS-CoV-2 antiviral agents: remdesivir, Veklury

Treatment (remdesivir)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a hematologic malignancy and/or autoimmune disease and 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
• Received bispecific antibody therapy (bsAb) within 3 months
• 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:
• 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).
• points:
• Age ≥ 40 years

You may not qualify if:

• 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
• New lower respiratory tract radiographic abnormalities or clinical symptoms after RSV-associated symptom onset that are suspected to be due to RSV
• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Gilead Sciences: collaborator

Study Sites (3)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases; Respiratory Syncytial Virus Infections

Interventions

remdesivir; Specimen Handling

Condition Hierarchy (Ancestors)

Immune System Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Joshua Hill, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Hill, MD

CONTACT

206-667-6504; Jahill3@fredhutch.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: December 23, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)