Remdesivir for Respiratory Syncytial Virus Infection

Recruiting at 2 trial locations

Overseen By Joshua 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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 1-2 weeks

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Remdesivir for treating Respiratory Syncytial Virus Infection?

Remdesivir has shown moderate effectiveness in improving clinical outcomes for patients hospitalized with COVID-19, a different viral infection, by reducing hospitalization time and aiding in rapid recovery of respiratory issues. ^{1 2 3 4 5}

Is remdesivir generally safe for humans?

Remdesivir has been associated with potential safety concerns, including liver and kidney issues, and possible heart-related events. Some reports have noted serious adverse effects, such as elevated liver enzymes, acute kidney injury, and bradycardia (slow heart rate), which may lead to severe outcomes. Further studies are needed to fully understand these risks. ^{6 7 8 9 10}

How is the drug Remdesivir unique for treating Respiratory Syncytial Virus (RSV) infection?

Remdesivir is unique because it is a broad-spectrum antiviral drug that works by inhibiting viral RNA polymerase, which is essential for virus replication. While it is primarily known for treating COVID-19, its potential use for RSV is novel as there are limited standard antiviral treatments specifically for RSV. ^{2 3 11 12 13}

What is the purpose of this trial?

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.

Research Team

Joshua Hill, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Treatment (remdesivir) Experimental Treatment 4 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.

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

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Rapid Response to Remdesivir in Hospitalised COVID-19 Patients: A Propensity Score Weighted Multicentre Cohort Study. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

Remdesivir in kidney transplant patients with SARS-CoV-2 pneumonia. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

[Remdesivir in kidney transplant patients with SARS-CoV-2 pneumonia]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Outpatient Intravenous Remdesivir to Prevent Progression to Severe COVID-19: An Observational Study from a Greek Hospital. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiac Events Potentially Associated to Remdesivir: An Analysis from the European Spontaneous Adverse Event Reporting System. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Severe Bradycardia Leading to Hemodynamic Instability Associated with Remdesivir Use in a Patient with COVID-19 Pneumonia. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Assessment of adverse events associated with remdesivir use for coronavirus disease 2019 using real-world data. [2022]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Remdesivir Use in Low Weight, Premature, and Renally Impaired Infants With SARS-CoV-2 Infection in Sheikh Khalifa Medical City, UAE: Case Series. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness of remdesivir in patients with COVID-19 under mechanical ventilation in an Italian ICU. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Expanded profiling of Remdesivir as a broad-spectrum antiviral and low potential for interaction with other medications in vitro. [2023]