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Number of Visits: 14

Duration: 1-2 weeks

60 Participants Needed

Remdesivir for Respiratory Syncytial Virus Infection

Recruiting at 2 trial locations

Overseen ByJoshua Hill, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Fred Hutchinson Cancer Center

Must not be taking: Ribavirin, Investigational antivirals

Disqualifiers: Pregnancy, Oxygen dependency, RSV vaccine, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of an antiviral drug called remdesivir in treating respiratory syncytial virus (RSV) infections in individuals with weakened immune systems due to certain cancer therapies. These therapies increase susceptibility to infections, and RSV can be particularly dangerous, causing severe lung problems. The trial seeks participants who have RSV symptoms and have recently received treatments like stem cell transplants or specific antibody therapies. It may suit individuals with a confirmed RSV infection and ongoing cancer treatment that affects the immune system. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have received certain antiviral therapies for RSV recently.

Is there any evidence suggesting that remdesivir is likely to be safe for humans?

Research has shown that remdesivir is safe for treating various viral infections, including COVID-19 in children. Studies have found that remdesivir effectively stops viruses from spreading in the body and has been well-tolerated, with no major safety concerns reported.

In this trial, researchers are testing remdesivir for respiratory syncytial virus (RSV) infections. Animal studies suggest it may work against RSV as well. Although specific safety data for remdesivir in RSV patients is not yet available, its safety record in other conditions, such as COVID-19, is promising. This indicates that remdesivir is generally considered safe for use in humans based on previous research.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Most treatments for Respiratory Syncytial Virus (RSV) focus on supportive care, like oxygen therapy and hydration, or preventive measures with monoclonal antibodies. But remdesivir works differently, targeting the virus directly by interfering with its ability to replicate. Researchers are excited about remdesivir because it's delivered intravenously, potentially offering a quick and powerful approach, which might lead to faster recovery times for patients with RSV. This direct antiviral action sets it apart from the standard supportive treatments, potentially providing a more effective way to combat the virus.

What evidence suggests that remdesivir might be an effective treatment for RSV infection?

Studies have shown that remdesivir can effectively lower the risk of hospitalization and death in adults at risk of severe illness. Research indicates that remdesivir works well against RSV, a virus, as demonstrated in animal studies. It also helps reduce the amount of virus in the body. Specifically, patients who received remdesivir early had a better chance of survival. This trial will evaluate remdesivir's potential to help manage RSV infections, especially in people with weakened immune systems.¹ ² ³ ⁴ ⁶

Who Is on the Research Team?

Joshua Hill, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for immunocompromised individuals with an upper respiratory tract infection due to RSV. It's specifically aimed at patients undergoing cellular or bispecific antibody therapy, which can include those with conditions like multiple myeloma or lymphoma.

Inclusion Criteria

Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)

Have one of the following underlying diseases and/or 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, Have multiple myeloma (MM) and received bispecific antibody therapy (bsAb) within 3 months, Have lymphoma and received bsAb within 3 months

Willingness to take study drug and complete necessary study procedures

See 4 more

Exclusion Criteria

Alanine aminotransferase (ALT) > 10 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

See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remdesivir intravenously over 30-120 minutes on days 1-5, with the option to extend to day 10 at the investigator's discretion

1-2 weeks

Daily visits for IV administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including nasal swabs and blood sample collection

4 weeks

Follow-up visits on day 14 and 29

What Are the Treatments Tested in This Trial?

Interventions

Remdesivir

Trial Overview The study is testing the effectiveness of remdesivir in treating RSV infections in the upper respiratory tract among immunocompromised patients. Participants will undergo biospecimen collection, nasal swabs, and survey administration as part of the phase II trial process.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: Treatment (remdesivir)Experimental Treatment4 Interventions

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Remdesivir was the most commonly reported medication for COVID-19 in the WHO database, with 4944 individual case safety reports (ICSRs) indicating that 93% of these cases identified remdesivir as the sole suspect medicine, highlighting its widespread use.

The analysis revealed significant adverse drug reactions (ADRs) associated with remdesivir, including liver dysfunction, kidney injury, and bradycardia, suggesting new safety concerns that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020.Rocca, E., Gauffin, O., Savage, R., et al.[2022]

Remdesivir, when administered for 10 days, is considered a safe antiviral treatment for hospitalized COVID-19 patients, showing significantly lower rates of serious adverse events compared to placebo and 5-day remdesivir.

However, there was no significant difference in mortality rates or overall tolerability between the 10-day remdesivir treatment and the control groups, indicating that while it is safe, it may not provide additional benefits in reducing death rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety, tolerability and mortality reduction efficacy of remdesivir; based on randomized clinical trials, observational and case studies reported safety outcomes: an updated systematic review and meta-analysis.Santenna, C., Vidyasagar, K., Amarneni, KC., et al.[2023]

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC10912415/

Evaluation of the safety profile and therapeutic efficacy ...The PINETREE trial found that a three-day course of remdesivir was associated with a reduced risk of hospitalization and death in adults with risk factors and ...

2.clinicaltrials.govclinicaltrials.gov/study/NCT06873633?term=remdesivir&viewType=Table&rank=9

NCT06873633 | Safety, Pharmacokinetics, and Antiviral ...Remdesivir (RDV) has shown potent antiviral activity against RSV A in an animal model. Remdesivir has been also shown to be a safe treatment option in pediatric ...

3.sciencedirect.comsciencedirect.com/science/article/pii/S1995820X25000033

Current antiviral therapies and promising drug candidates ...The results for the viral load demonstrated 63.05% and 55.25% reductions for the 350 mg and 200 mg doses, respectively. In addition, compared with the placebo ...

4.nature.comnature.com/articles/s41392-022-00963-7

Oral remdesivir derivative VV116 is a potent inhibitor of ...We reported an oral RDV derivative, VV116, which demonstrated potent anti-SARS-CoV-2 efficacy in hACE2-transduced Balb/c mice.

5.academic.oup.comacademic.oup.com/cid/article-abstract/79/Supplement_4/S149/7823126

Remdesivir-Associated Survival Outcomes Among ...Remdesivir was associated with a significantly lower mortality rate among patients with no supplemental oxygen (adjusted hazard ratio [95% confidence interval], ...

6.fredhutch.orgfredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15370.remdesivir-for-the-treatment-of-upper-respiratory-tract-infection-due-to-rsv-in-immunocompromised-individuals.html

Remdesivir for the Treatment of Upper Respiratory Tract ...This phase II trial tests how well remdesivir works for treatment of respiratory syncytial virus (RSV) infection of the upper respiratory ...

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Remdesivir for Respiratory Syncytial Virus Infection

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

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