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New treatment option for Hematopoietic and Lymphatic System Neoplasm
Official title Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
ClinicalTrials.gov ID: NCT06817889
What this study is testing
What is Remdesivir?
Remdesivir is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematopoietic and lymphatic system neoplasm.
Also referred to 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.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Symptomatic RSV infection of the upper respiratory tract, with symptom onset and positive microbiologic testing within the 5 days prior to day 1 (RDV...
- Receiving treatment for a refractory or relapsed hematologic malignancy, or received a hematopoietic cell transplant (HCT), chimeric antigen receptor...
You likely can't join if
- Received or receiving an approved or authorized direct-acting antiviral therapy with potential how well it works against RSV (e.g. ribavirin) for ≥...
- 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- Receiving treatment 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...
- 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) 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...
- 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
- Received or receiving an approved or authorized direct-acting antiviral therapy with potential how well it works against RSV (e.g. ribavirin) for ≥ 24 hours within the prior 7 days, and/or expected to receive anti-RSV...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.