Trials / Recruiting
RecruitingNCT06817889
Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
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 Patients Receiving Cellular or Bispecific Antibody Therapies
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remdesivir | Given IV |
| OTHER | Survey Administration | Ancillary studies |
| PROCEDURE | Biospecimen Collection | Undergo blood sample collection |
| PROCEDURE | Nasal Swab | Undergo nasal swabs |
Timeline
- Start date
- 2025-12-23
- Primary completion
- 2027-11-30
- Completion
- 2027-11-30
- First posted
- 2025-02-10
- Last updated
- 2026-02-27
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06817889. Inclusion in this directory is not an endorsement.