Hematopoietic and Lymphatic System NeoplasmPhase 2NCT06817889
Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
A Phase 2 study testing Remdesivir, Survey Administration and Biospecimen Collection in people with Hematopoietic and Lymphatic System Neoplasm and Autoimmune Disease, run by Fred Hutchinson Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Autoimmune Disease, Respiratory Syncytial Virus Infection
- What is being tested?
- Remdesivir, Survey Administration and Biospecimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Dec 2025to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Actively receiving treatment (within the past 90 days) 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Sanjeet Dadwal, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Fareed Khawaja, MBBS
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Joshua Hill, MD, 206-667-6504, Jahill3@fredhutch.org
Joshua Hill, MD
About this study
Official title: 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 High-Risk Immunocompromised Patients
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.
Read the detailed description
OUTLINE:
Patients receive remdesivir intravenously (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.
After completion of study treatment, patients are followed up on day 14 and 29.
- Conditions
- Hematopoietic and Lymphatic System Neoplasm, Autoimmune Disease, Respiratory Syncytial Virus Infection
- Being tested
- Remdesivir, Survey Administration, Biospecimen Collection, Nasal Swab
- Medical subject headings
- Autoimmune Diseases, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Also called 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
Given IV
Survey AdministrationOther
Ancillary studies
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Nasal SwabProcedure or surgery
Also called Nasal Swab Test, Nasopharyngeal Swab, Nasopharyngeal Swab Test
Undergo nasal swabs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Remdesivir; Other: Survey Administration; Procedure: Biospecimen Collection; Procedure: Nasal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hours
Will be estimated with 95% Wilson confidence intervals.
Measured: Up to day 29
Secondary outcomes (10)
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.
Measured: Up to day 29
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.
Measured: Up to day 29
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.
Measured: Up to day 29
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.
Measured: Up to day 29
Proportion of participants who develop new or worsening pulmonary infiltrates
Based on radiographic imaging of the lungs for standard of care.
Measured: Up to day 29
Proportion of participants requiring high-flow nasal cannula, non-invasive ventilation, or invasive mechanical ventilation for ≥ 24 consecutive hours
Will consider using time-to-event methods such as cumulative incidence curves and Cox proportional hazards regression.
Measured: Up to day 29
Proportion of participants admitted to intensive care unit
Will consider using time-to-event methods such as cumulative incidence curves and Cox proportional hazards regression.
Measured: Up to day 29
Proportion of participants who die
Will consider using time-to-event methods such as cumulative incidence curves and Cox proportional hazards regression.
Measured: Up to day 29
Change from baseline in RSV nasal swab viral load
Will be computed among participants with baseline nasal viral loads ≥ the lower limit of quantitation and compared between cohorts using linear regression with propensity score weights.
Measured: From baseline through day 3 and 5
Maximum daily Respiratory Infection Intensity and Impact Questionnaire (RiiQ) score
The RiiQ is a 13-item questionnaire, with each item representing a different RSV-associated symptom and graded on a 4-point scale (0 = None, 1 = Mild, 2 = Moderate, and 3 = Severe). Greater scores indicate greater symptom severity. Recall period is the past 24 hours.
Measured: From baseline to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start23 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Joshua Hill, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817889
- Sponsor's protocol ID
- RG1125015
- Other IDs
- NCI-2025-00572, 20650
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 High-Risk Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT06817889
- Acronym / sponsor ID
- RG1125015
- Conditions
- Hematopoietic and Lymphatic System Neoplasm, Autoimmune Disease, Respiratory Syncytial Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE:
Patients receive remdesivir intravenously (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.
After completion of study treatment, patients are followed up on day 14 and 29.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (remdesivir) | Experimental | Drug: Remdesivir, Other: Survey Administration, Procedure: Biospecimen Collection, Procedure: Nasal SwabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
- Actively receiving treatment (within the past 90 days) 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemdesivirAlso: 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, RDVGiven IV | Drug | Treatment (remdesivir) |
| Survey AdministrationAncillary studies | Other | Treatment (remdesivir) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (remdesivir) |
| Nasal SwabAlso: Nasal Swab Test, Nasopharyngeal Swab, Nasopharyngeal Swab TestUndergo nasal swabs | Procedure or surgery | Treatment (remdesivir) |
Primary outcome
Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hours
Time frame: Up to day 29
Will be estimated with 95% Wilson confidence intervals.
10 secondary outcomes
Incidence of treatment-emergent adverse events (AEs) and laboratory abnormalities
Time frame: Up to day 29
Incidence of serious adverse events and AEs leading to study drug discontinuation
Time frame: Up to day 29
Proportion of participants with RSV-related hospitalization (if not hospitalized at the time of first dose) or death
Time frame: Up to day 29
Supplemental oxygen free days
Time frame: Up to day 29
Proportion of participants who develop new or worsening pulmonary infiltrates
Time frame: Up to day 29
Proportion of participants requiring high-flow nasal cannula, non-invasive ventilation, or invasive mechanical ventilation for ≥ 24 consecutive hours
Time frame: Up to day 29
Proportion of participants admitted to intensive care unit
Time frame: Up to day 29
Proportion of participants who die
Time frame: Up to day 29
Change from baseline in RSV nasal swab viral load
Time frame: From baseline through day 3 and 5
Maximum daily Respiratory Infection Intensity and Impact Questionnaire (RiiQ) score
Time frame: From baseline to day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Hill, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remdesivir, Survey Administration and Biospecimen Collection in people with Hematopoietic and Lymphatic System Neoplasm and Autoimmune Disease, run by Fred Hutchinson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Hill, MD (206-667-6504, Jahill3@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hours (time frame: Up to day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.