ClinicalTrials.gg
RecruitingNCT06817889Updated Oct 1, 2026

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

A Phase 2 interventional study of Remdesivir and Survey Administration in Hematopoietic and Lymphatic System Neoplasm, Autoimmune Disease and Respiratory Syncytial Virus Infection, sponsored by Fred Hutchinson Cancer Center. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Updated Oct 1, 2026Eligibility revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 341 studies in Autoimmune Diseases with a site in United States — 91 open to participants now, 117 under way, 19 of them phase 3. Autoimmune Diseases · United States.

Planned enrollment
114th of 243
60 · median 53
Started
2025
with 22 others
Phase 2
75 of 341
13 open now
Primary completion
2027-11
later than 48 of 111 live
Registered
306th of 341
by date

Among the 341 studies in Autoimmune Diseases with a site in United States, this one is the 114th largest by planned enrollment of the 243 interventional ones that give a count, is one of 23 that started in 2025, is one of 75 in phase 2, reaches primary completion later than 48 of the 111 other live ones, and was the 306th registered.

Autoimmune Diseases

802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.

Browse Autoimmune Diseases studies →

Open to participants now

91 of the 341 studies in Autoimmune Diseases with a site in United States are open now. Recruiting first, the newest first:

85 more — sign in →

All 91 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 194 Autoimmune Diseases studies recruiting now, 89 (46%) set no upper age limit and 79 (41%) stop at 75 or younger; 55 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Hematopoietic and Lymphatic System Neoplasm
  • Autoimmune Disease
  • Respiratory Syncytial Virus Infection
04

Who can participate

The criteria were revised on the registry on Oct 1, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged ≥ 18 years
  • Willing and able to provide written , 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 or relapsed hematologic , 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:

    • 1 point:

      • Recent (within the prior 30 days) HCT, autologous HCT, or CARTx
      • within the prior 30 days for management of (GVHD) or cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
    • 2 points:

      • Age ≥ 40 years
    • 3 points:

      • (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 who engage in heterosexual intercourse must agree to use protocol-specified method(s) of as described

Exclusion criteria

Exclusion Criteria:

  • 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 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
  • (ALT) ≥ 5 times the within 7 days prior to screening
  • 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 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)
  • 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 or allergy to the study drug, its metabolites, or formulation
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

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

Interventions

  • 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

  • OtherSurvey Administration

    Ancillary studies

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

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

  • ProcedureNasal Swab

    Undergo nasal swabs

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

06

What researchers measure

Primary outcomes

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

    Will be estimated with 95% Wilson confidence intervals.

    Time frame: Up to day 29

Secondary outcomes

  1. 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.

    Time frame: Up to day 29

  2. 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.

    Time frame: Up to day 29

  3. 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.

    Time frame: Up to day 29

  4. 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.

    Time frame: Up to day 29

  5. Proportion of participants who develop new or worsening pulmonary infiltrates

    Based on radiographic imaging of the lungs for standard of care.

    Time frame: Up to day 29

  6. 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.

    Time frame: Up to day 29

  7. 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.

    Time frame: Up to day 29

  8. Proportion of participants who die

    Will consider using time-to-event methods such as cumulative incidence curves and Cox proportional hazards regression.

    Time frame: Up to day 29

  9. 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.

    Time frame: From baseline through day 3 and 5

  10. 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.

    Time frame: From baseline to day 29

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Nov 2027, 23 months after the start.

Of 31 non-industry phase 2 interventional studies under Autoimmune Diseases, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 114. This study's planned 23 months is below that.

Counting every sponsor, half of 60 studies reached it within 55 months; a quarter within 34 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2025
First posted
Feb 10, 2025
StartActual
Dec 23, 2025
Primary completionEst.
Nov 30, 2027
CompletionEst.
Nov 30, 2027
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedReceivingActively 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)
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Eligibility 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedReceivingActively 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)
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06817889
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
Dec 23, 2025
Primary completion
Nov 30, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Joshua Hill, MD
Contact
Jahill3@fredhutch.org
206-667-6504
Joshua Hill, MD
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Remdesivir

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