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
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.
• 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 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)
• 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
• Categorized as moderate-risk (overall score 3-6) or high-risk (overall score 7-12) 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) 92% 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 ≥ 92%) at screening
• 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