RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
Condition: Upper Respiratory Tract Infection; Lower Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Intervention: RI-001; RI-001; RI-001
Intervention description: Dose 1; Dose 2; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Transplant; Immunosuppression

Summary:

      RSV infections can develop into serious, life threatening conditions among immunocompromised
      patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of
      RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients
      identified as being infected with RSV in the upper respiratory tract.
    

Eligibility criteria:

        Inclusion Criteria:

          1. An IEC/IRB approved written informed consent signed and dated by the patient or by
             parent(s) or a legally acceptable representative. The consent form or a specific
             assent form, where required, will be signed and dated by minors.

          2. Documented Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT),
             Pulmonary/Cardiac Transplant, Pulmonary Transplant or Liver Transplant within the 2
             years prior to randomization to the study drug.

          3. Male/Female patients age: (Pediatric) ≥2 years and <16 years at the time of informed
             consent.

          4. Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed
             consent.

          5. Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1.

          6. Patients must be actively taking at least one immunosuppressive agent.

          7. Patients must have a positive RSV RT-PCR at the time of the randomization procedures.

          8. Female patients must be of non-childbearing potential or have a negative pregnancy
             test prior to study start and be deemed not at risk of becoming pregnant by adherence
             to a reliable contraceptive method for the duration of the study. Females of
             non-childbearing potential are defined as women who have had a hysterectomy, bilateral
             oophorectomy, tubal ligation or who have been post-menopausal for at least two years,
             or are considered to be sterile due to recent chemotherapy.

          9. Female patients who are not breast-feeding.

         10. Patient/legally acceptable representative considered as reliable and capable of
             adhering to the protocol (e.g. able to understand and complete diaries and
             questionnaires), visit schedules or treatment regimen according to the judgment of the
             Investigator.

        Exclusion Criteria:

          1. Documented RSV lower respiratory tract infection (respiratory assessment score is
             greater than 1) as determined by the site investigators or research staff.

          2. Requirement for mechanical ventilation, extracorporeal membrane oxygenation,
             continuous positive airway pressure or other mechanical respiratory or cardiac support

          3. Unstable respiratory status so severe that survival is not expected for longer than 6
             months.

          4. End organ dysfunction resulting in anticipated survival of less than 6 months.

          5. Known to be HIV positive.

          6. Administration of any RSV specific products, including palivizumab (Synagis®) in the 3
             months prior to randomization procedures.

          7. Previous, current, or planned administration of an investigational RSV vaccine.

          8. Known hypersensitivity to immunoglobulin.

          9. Known Immunoglobulin (IgA) deficiency

         10. Known renal impairment requiring any form of dialysis (HD, PD, CRRT).

         11. Known hemodynamically significant congenital heart disease.

         12. Previous poor compliance with visit schedules.

         13. Severe medical, neurological or psychiatric disorders or laboratory values which may
             have an impact on the safety of the patient.

         14. Concurrent participation in other investigational drug product studies; any exception
             must be approved by the ADMA Biologics Medical Director.