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Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever

Primary Purpose

Viral Hemorrhagic Fever

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ribavirin
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Hemorrhagic Fever

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets the case definition for a probable or a suspected case of CCHF or LF
  • Must be DoD-affiliated personnel including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents as well as allied military forces and local nationals who have been granted access to the medical facility
  • Is at least 18 years of age (17, if active military) and not greater than 65 years of age
  • Has a blood sample drawn and a type and cross-match ordered for transfusion
  • Has a hemoglobin greater than or equal to10 g/dL before starting IV ribavirin
  • Agrees to collection of required specimens
  • Agrees to report any adverse events for the duration of the protocol
  • Agrees to a follow-up visit and to donate blood and urine specimens at Day 14 (±2 days) after the first dose of IV ribavirin and agrees to all follow-up visits for anemia or other medical conditions as required by the attending physician
  • Female patient of childbearing potential must have a pregnancy test. Patient will be counseled concerning the risks of IV ribavirin versus no treatment if the pregnancy test is positive. If the test is negative, patient agrees to take precautions to avoid pregnancy during treatment and for 7 months after treatment.
  • Male patient agrees not to have intercourse with a pregnant woman and to take precautions to avoid producing pregnancies during treatment and for 7 months after ribavirin treatment.
  • Female patient agrees not to breastfeed during treatment and for 7 months after ribavirin treatment

Exclusion Criteria:

  • • Has known intolerance to ribavirin.

    • Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission).
    • Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV ribavirin
    • Has history of hemoglobinopathies (ie, sickle-cell anemia or thalassemia major).
    • Has history of autoimmune hepatitis.
    • Has serum calculated creatinine clearance of < 30 mL/min.
    • History of second or third degree heart block or sick sinus syndrome without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome.
    • A sinus bradycardia of less than 40 beats per minute (see below).
    • Is currently being treated with didanosine (ddI). ddI must be discontinued before starting IV ribavirin.

Relative Exclusion Criteria: At the principal investigator's (PI) discretion, an individual may be treated with IV ribavirin, with caution, if one or more of these criteria are present.

  • A positive pregnancy test. The patient will be informed of the risk and benefit of treatment with IV ribavirin versus no ribavirin treatment for CCHF (generally associated with high mortality) and severe cases of Lassa fever (high mortality rates) versus mild cases of Lassa fever (low mortality rates).
  • A New York Heart Association cardiac functional capacity of Class II or greater for atherosclerotic heart disease (ASHD) and congestive heart failure (CHF).
  • Known cardiac defects that may predispose the subject to bradyarrhythmias, such as second or third degree heart block or sick sinus syndrome without a pacemaker, but capability of pacemaker placement, if needed.
  • Sinus bradycardia of 41-49 beats per minutes, if the individual is not known to have a low resting heart rate related to physical conditioning.
  • Use of drugs known to result in bradyarrhythmias (certain beta blockers and calcium channel blockers, digoxin, as well as clonidine, cholinesterase inhibitors, and lithium).
  • History of gout

Sites / Locations

  • Landstuhl Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

10-day course of treatment

Arm Description

10-day course of treatment with follow-up 14 ± 2 days after first dose

Outcomes

Primary Outcome Measures

Adverse reactions

Secondary Outcome Measures

Full Information

First Posted
June 24, 2015
Last Updated
April 3, 2022
Sponsor
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT02483260
Brief Title
Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever
Official Title
Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2016 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To provide an intravenous ribavirin therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever, specifically Crimean-Congo hemorrhagic fever or Lassa fever.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Hemorrhagic Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10-day course of treatment
Arm Type
Other
Arm Description
10-day course of treatment with follow-up 14 ± 2 days after first dose
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Virazole
Intervention Description
Loading dose, 33 mg/kg (maximum dose: 2.64 g) Followed in 6 hours by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses) Followed by a dose of 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 6 days (18 doses).
Primary Outcome Measure Information:
Title
Adverse reactions
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets the case definition for a probable or a suspected case of CCHF or LF Must be DoD-affiliated personnel including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents as well as allied military forces and local nationals who have been granted access to the medical facility Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Has a hemoglobin greater than or equal to10 g/dL before starting IV ribavirin Agrees to collection of required specimens Agrees to report any adverse events for the duration of the protocol Agrees to a follow-up visit and to donate blood and urine specimens at Day 14 (±2 days) after the first dose of IV ribavirin and agrees to all follow-up visits for anemia or other medical conditions as required by the attending physician Female patient of childbearing potential must have a pregnancy test. Patient will be counseled concerning the risks of IV ribavirin versus no treatment if the pregnancy test is positive. If the test is negative, patient agrees to take precautions to avoid pregnancy during treatment and for 7 months after treatment. Male patient agrees not to have intercourse with a pregnant woman and to take precautions to avoid producing pregnancies during treatment and for 7 months after ribavirin treatment. Female patient agrees not to breastfeed during treatment and for 7 months after ribavirin treatment Exclusion Criteria: • Has known intolerance to ribavirin. Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission). Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV ribavirin Has history of hemoglobinopathies (ie, sickle-cell anemia or thalassemia major). Has history of autoimmune hepatitis. Has serum calculated creatinine clearance of < 30 mL/min. History of second or third degree heart block or sick sinus syndrome without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome. A sinus bradycardia of less than 40 beats per minute (see below). Is currently being treated with didanosine (ddI). ddI must be discontinued before starting IV ribavirin. Relative Exclusion Criteria: At the principal investigator's (PI) discretion, an individual may be treated with IV ribavirin, with caution, if one or more of these criteria are present. A positive pregnancy test. The patient will be informed of the risk and benefit of treatment with IV ribavirin versus no ribavirin treatment for CCHF (generally associated with high mortality) and severe cases of Lassa fever (high mortality rates) versus mild cases of Lassa fever (low mortality rates). A New York Heart Association cardiac functional capacity of Class II or greater for atherosclerotic heart disease (ASHD) and congestive heart failure (CHF). Known cardiac defects that may predispose the subject to bradyarrhythmias, such as second or third degree heart block or sick sinus syndrome without a pacemaker, but capability of pacemaker placement, if needed. Sinus bradycardia of 41-49 beats per minutes, if the individual is not known to have a low resting heart rate related to physical conditioning. Use of drugs known to result in bradyarrhythmias (certain beta blockers and calcium channel blockers, digoxin, as well as clonidine, cholinesterase inhibitors, and lithium). History of gout
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LTC Kristen Bauer, MD
Phone
314-590-5827
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LTC Kristen Bauer, MD
Organizational Affiliation
Landstahl Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landstuhl Regional Medical Center
City
Landstuhl
State/Province
APO Ae
ZIP/Postal Code
09180
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maj. Charla Geist
First Name & Middle Initial & Last Name & Degree
Maj. Charla Geist

12. IPD Sharing Statement

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Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever

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