Experimental IV drug targets deadly fevers in military personnel

NCT ID NCT02483260

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial investigates whether intravenous ribavirin can help treat people with Crimean-Congo hemorrhagic fever or Lassa fever, two severe viral infections. The study enrolls up to 30 military-affiliated adults who have a probable or suspected case. Participants receive a specific dosing regimen of ribavirin over 10 days, and researchers monitor for side effects and outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ribavirin (intravenous)
What this could lead to
If effective, ribavirin could provide a treatment option for these rare but severe viral fevers, potentially reducing complications.
What could go wrong
This is a small, early-stage protocol with only 30 participants, so results may not apply broadly. Ribavirin can cause side effects like anemia.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Started

Jun 2016

Expected to finish

Dec 2028

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 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

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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.

  1. The places running it

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

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Landstuhl Regional Medical Center

    Landstuhl, APO AE, 09180, Germany

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