Army tests IV antiviral against Kidney-Damaging hemorrhagic fever

NCT ID NCT04283513

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • Landstuhl Regional Medical Center

    Landstuhl, Germany

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