Respiratory Syncytial Virus - RSV Protocol

January 21, 2021 updated by: M.D. Anderson Cancer Center

An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Groups:

If you are found to be eligible to take part in this study and the study doctor thinks that the disease requires treatment at this time, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:

  • If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will receive the drug for up to 10 days.
  • If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10 days.

If the study doctor does not think that the disease requires treatment at this time, you will be assigned to Group 3. If you are in Group 3, you will not receive treatment with ribavirin, but you will have the same tests and procedures at the study visits described below.

Study Visits:

At all study visits, you will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any other drugs you may be taking.

On Day 3 (+/- 1 day):

  • You will have a physical exam, including measurement of your vital signs
  • Your nasal passages will be checked for RSV.

On Days 7 and 14 (+/- 1 day):

  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • You will have a physical exam, including measurement of your vital signs
  • Your nasal passages will be checked for RSV.

Length of Study:

If you are in Groups 1 or 2, you will receive the study drug for up to 10 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. If your doctor thinks you need treatment longer than 10 days, you will receive that as part of your routine care. This may mean changing to receiving the drug in inhaled form if you began the study receiving it by mouth.

All participants will have end-of-study and follow-up visits, as described below.

End-of-Study Visit:

If you are in Groups 1 or 2, the end-of-study visit will be about 14 days after your last dose of the study drug. If you are in Group 3, the end-of-study visit will take place at about Day 21. The following tests and procedures will be performed:

  • You will have a physical exam, including measurement of your vital signs.
  • Blood (about 4 teaspoons) will be drawn for routine tests and to check for RSV antibodies.
  • Your nasal passages will be checked for RSV.
  • You will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any drugs you may be taking.

Follow-Up Visit:

About 6 to 10 weeks after your last dose of study drug, you will have a pulmonary function test to check your lung function.

This is an investigational study. Ribavirin is FDA approved and commercially available for the treatment of hepatitis C when given by mouth, and for severe RSV in children when inhaled. Giving the drug to adults with weak immune systems after a stem cell transplant is investigational.

Up to 96 patients will take part in this study. All will be enrolled at MD Anderson.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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).
  2. 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).
  3. Patients must be at least 18 years of age and able to swallow pills.
  4. 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.
  5. 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).
  6. 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.
  7. Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study.
  8. Patients who will be enrolled on the observational arm should meet inclusion criteria # 2, 3, and 4 only.

Exclusion Criteria:

  1. Patients with previous history of hypersensitivity to ribavirin or its components
  2. 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).
  3. 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.
  4. Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
  5. 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
  6. Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) three times the upper limit of normal.
  7. Male partners of women who are pregnant (only for patients who are going to be randomised to either therapeutic arms).
  8. Patients with known history of autoimmune hepatitis, Hepatitic C or those with hemoglobinopathies (eg, thalassemia major, sickle cell anemia).
  9. Patients with creatinine clearance of less than or equal to 50 ml/Min
  10. Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors
  11. Patients who will be enrolled on the observational arm should not meet exclusion criteria #3 and 4 only.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled Ribavirin
Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
Drug: Ribavirin
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.
Drug: Ribavirin
One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).
Experimental: Oral Ribavirin
Group 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
Drug: Ribavirin
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.
Drug: Ribavirin
One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).
No Intervention: No Ribavirin
Group 3: No Ribavirin treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)
Time Frame: 14 days
Patient who developed signs of lower respiratory tract infection
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Roy F. Chemaly, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2011

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

December 30, 2011

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0813
  • NCI-2012-00021 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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