Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever

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)

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.
    



Study Type

Interventional


Primary Outcome

Adverse reactions


Condition

Viral Hemorrhagic Fever

Intervention

Ribavirin

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

June 16, 2016

Completion Date

December 2021

Primary Completion Date

August 2021

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

LTC Kristen Bauer, MD, 314-590-5827, 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02483260

Organization ID

S-13-08


Responsible Party

Sponsor

Study Sponsor

U.S. Army Medical Research and Development Command


Study Sponsor

LTC Kristen Bauer, MD, Principal Investigator, Landstahl Regional Medical Center


Verification Date

February 2021