Army tests IV antiviral against Kidney-Damaging hemorrhagic fever
NCT ID NCT04283513
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This phase 2 trial investigates whether intravenous ribavirin (Virazole) can reduce deaths in adults with hemorrhagic fever with renal syndrome (HFRS), a severe viral illness that can cause kidney failure. The study enrolls military-affiliated personnel with probable or suspected HFRS and measures mortality at 10, 14, and 28–60 days, along with tracking side effects. The goal is to determine if this antiviral treatment improves survival in this serious infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IV Ribavirin (Virazole)
- What this could lead to
- If effective, IV ribavirin could become a standard treatment to reduce deaths from HFRS, a serious viral infection affecting kidneys.
- What could go wrong
- This is a small, early-phase trial (50 participants) focused on safety and mortality reduction. The drug may not prove effective or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: A subject must meet all of the following criteria to be included in the study: * Meets the protocol case definition for a probable or suspected case (see Section 8.5.2 and Section 8.5.3) * Has read and signed the Informed Consent. * Must be Department of Defense (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. * Agrees to have a blood sample drawn and a type and cross-match ordered for transfusion. * Agrees to collection of required specimens. * Agrees to report any adverse events (AEs) for the duration of the patient's treatment protocol participation. * Agrees to follow-up visits and to donate blood and urine specimens at Day 10, Day 14, and once 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. * Has a hemoglobin of 10 g/dL or higher before starting IV ribavirin. * Women who are breastfeeding agree to discontinue breastfeeding during treatment with IV ribavirin and during the 7-month post-treatment period. * Woman of childbearing potential must have a negative pregnancy test within 24 hours before starting treatment and agrees not to become pregnant during treatment and for 7 months after receiving IV ribavirin. Treatment will be a maximum of 25 doses given over a 1 week time period. At least 2 reliable forms of effective contraception, including 1 barrier method, must be utilized during treatment and during the 7 months post treatment period.(See Section 12.1.6 Pregnancy) * Male subjects agree not to have intercourse with pregnant women during treatment and for 7 months after receiving IV ribavirin, and take precautions to avoid producing pregnancies in female partners during and for 7 months after receiving ribavirin. Treatment will be a maximum of 25 doses given over a 1 week time period. At least 2 reliable forms of effective contraception, including 1 barrier method, must be utilized during the treatment and during the 7 month post-treatment period (See Section 12.1.6 Pregnancy). Their female partner should use a highly effective contraceptive method (see Section 12.1.6). They agree to use a male condom plus an additional method with a failure rate of \< 1% per year). Exclusion Criteria: Individual will not be enrolled in the protocol if they meet any of the following criteria: * Has a known intolerance to ribavirin. * Is irreversibly ill on presentation, as defined by presence of profound shock, which does not respond to supportive therapy within 3 hours after admission. * Has a positive pregnancy test. * Has an estimated creatinine clearance \< 20 mL/minute * Is receiving renal dialysis. * Has a history of hemoglobinopathies (ie, sickle-cell anemia or thalassemia major). * Has a history of autoimmune hepatitis. * Has a hemoglobin less than 10 g/dL that cannot be corrected to ≥ 10 g/dL before initiation of IV ribavirin. * Has a New York Heart Association Cardiac functional capacity of Class II or greater for atherosclerotic heart diseases (ASHD) and congestive heart failure (CHF). Class II ASHD or greater includes angina that occurs at rest, with daily activities, and/or with slightly more prolonged or with slightly more vigorous activity than usual. Class II CHF or greater includes CHF resulting in mild symptoms with ordinary physical activity, or marked or severe limitations of activity \[See Appendix B for New York Heart Association Functional Classification of Angina and CHF\]. * Has known cardiac conduction defects that may predispose the patient to arrhythmias such as WPW; or a history of bradyarrhythmias, such as second or third degree heart block or sick sinus syndrome and no pacemaker * Has 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). * Is currently being treated with didanosine (ddI) or azathioprine. DdI and azathioprine must be discontinued before starting IV ribavirin
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Landstuhl Regional Medical Center
Landstuhl, Germany
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