Ribavirin for Hemorrhagic Fever With Renal Syndrome

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected rodent hosts. HFRS is present throughout Korea. Treatment consists mainly of supportive care with careful attention to control of blood pressure and fluid balance and/or dialysis. Early initiation of IND Intravenous Ribavirin has been shown to be an effective treatment for HFRS and may prevent the need for dialysis. It is important to initiate therapy based on a diagnosis consistent with HFRS and a history that makes exposure likely. This study will monitor the clinical events that occur with HFRS as well as the safety and efficacy of Ribavirin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

• Have read and signed the Informed Consent (see Exception for Emergency Treatment, Section 12.0).

• Are at least 18 years of age (17, if active military) and not greater than 65 years of age.

• Meet the case definition for a probable or suspected case (see Section 5.0).

• Have a blood sample drawn and a type and cross-match ordered for transfusion.

• Agree to collection of required specimens.

• Agree to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study.

• Agree to a follow-up visit and to donate blood and urine specimens at day 10, day 14 and between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician.

• Women of childbearing age must have a negative pregnancy test and agree not to become pregnant for 7 months after receiving Ribavirin. Women will be counseled concerning the risks of IV Ribavirin.

• Men agree not to have intercourse with pregnant women for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies for 7 months after receiving Ribavirin.

• Have a hemoglobin greater than or equal to10 g/dL before starting IV Ribavirin.

Exclusion Criteria:

• A known intolerance to Ribavirin.

• Are irreversibly ill on presentation, as defined by presence of profound shock, which does not respond to supportive therapy within 3 hours after admission.

• A positive pregnancy test.

• An estimated creatinine clearance < 20 ml/minute.

• A history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major).

• A history of autoimmune hepatitis.

• A hemoglobin less than 10 g/dL that cannot be corrected to ≥10 g/dL before initiation of IV Ribavirin.

• A New York Heart Association Cardiac functional capacity of Class II or greater for ASHD and CHF.

• Known cardiac conduction defects that may predispose the subject to arrhythmias, such as second or third degree heart block or sick sinus syndrome (and no pacemaker), or Wolfe-Parkinson-White Syndrome.

• A sinus bradycardia of less than 40 beats per minute (or sinus bradycardia less than 50 beats per minute if the individual is not known to have a low resting heart rate related to physical conditioning).

• Concurrent therapy with Didanosine (ddI). DdI must be discontinued before starting the IV Ribavirin.

Relative Exclusion Criteria: PI's discretion to use IND Ribavirin with caution. The PI should make the decision concerning enrollment of subjects with relative exclusion criteria based on risk versus benefit of the drug.

• Creatinine clearance is 20 - 30 mL/minute

• History of gout or tophaceous gout

• On any drug that may decrease heart rate (beta-blockers, calcium channel blockers, digoxin IV Ribavirin should be avoided in severe renal insufficiency, and its use with a creatinine clearance between 20 to 30 mL/min should be based on the risk versus benefit. If used, the drug should be discontinued if the creatinine clearance decreases to 20 mL/min or lower.