Respiratory Syncytial Virus - RSV Protocol

NCT01502072 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2011-0813NCI-2012-00021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied. Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.

Conditions

Bone Marrow Transplant Infection; Infection in Marrow Transplant Recipients; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus Pneumonia; Cancer; Acute Leukemia

Keywords

Ribavirin; Ribavirin Aerosol; Respiratory Syncytial Virus; RSV; upper respiratory tract infection; URI; Lower respiratory tract Infection; LRI; pneumonia; aerosolized ribavirin; HSCT; Hematopoietic stem cell transplantation; oral ribavirin therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)

  Patient who developed signs of lower respiratory tract infection

  14 days

Study Arms (3)

Inhaled Ribavirin

EXPERIMENTAL

Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.

Drug: Ribavirin

Oral Ribavirin

EXPERIMENTAL

Group 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.

Drug: Ribavirin

No Ribavirin

NO INTERVENTION

Group 3: No Ribavirin treatment.

Interventions

Ribavirin DRUG

Modified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask.

Inhaled Ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HSCT patients with either moderate or severe immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours (therapeutic arms). (Please see Appendix E for definitions and Immunodeficiency Scoring).
• HSCT patients with mild immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm).
• Patients must be at least 18 years of age and able to swallow pills.
• Patients with RSV infection limited to the URT as documented by negative Chest radiographic findings within the last 48 hours of enrollment and pulse oxygenation of more than 90 mm of Hg on room air.
• Women of child bearing potential with a negative urine or blood pregnancy test within a month of enrollment (only for patients who are going to be randomised to either therapeutic arms).
• Patients with Hemoglobin levels more than or equal to 8 g/dl would be eligible for the study even if they are currently receiving blood products.
• Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study.

You may not qualify if:

• Patients with previous history of hypersensitivity to ribavirin or its components
• Women who are pregnant or plan a pregnancy within 8 weeks after completion of treatment (only for patients who are going to be randomised to either therapeutic arms).
• Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm of Hg on room air.
• Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
• Patients who are considered to be moderately or severely anemic as per the NCI classification will not be included in the study, i.e patients with hemoglobin level less than 8 g/dl
• Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) three times the upper limit of normal.
• Male partners of women who are pregnant (only for patients who are going to be randomised to either therapeutic arms).
• Patients with known history of autoimmune hepatitis, Hepatitic C or those with hemoglobinopathies (eg, thalassemia major, sickle cell anemia).
• Patients with creatinine clearance of less than or equal to 50 ml/Min
• Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Neoplasms; Respiratory Tract Infections; Pneumonia

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Roy F. Chemaly, MD,MPH- Professor, Infectious Diseases
• Organization: UT MD Anderson Cancer Center

rfchemaly@mdanderson.org

(713) 745-1116

Study Officials

• Roy F. Chemaly, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 30, 2011
• Study Start: December 28, 2011
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 15, 2021
• Results First Posted: February 15, 2021

Record last verified: 2021-01

Locations

US (1)