Viral Hemorrhagic FeverNCT02483260
Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever
A study testing Ribavirin in people with Viral Hemorrhagic Fever, run by U.S. Army Medical Research and Development Command at 1 site in Germany.
Trial summary
Is ribavirin a therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever? Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Viral Hemorrhagic Fever
- What is being tested?
- Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jun 2016to Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- • 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever)
Is ribavirin a therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever?
Read the detailed description
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.
- Conditions
- Viral Hemorrhagic Fever
- Being tested
- Ribavirin
- Medical subject headings
- Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Also called Virazole
- Loading dose, 33 mg/kg (maximum dose: 2.64 g)
- Followed in 6 hours by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses)
- Followed by a dose of 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 6 days (18 doses).
| Study group | Role | What they receive |
|---|---|---|
| 10-day course of treatment | Other | 10-day course of treatment with follow-up 14 ± 2 days after first dose Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start16 Jun 2016
- Primary completionOct 2027 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Product expired, new lots are not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Hemorrhagic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joshua Hawley-Molloy, MD, Principal investigator, Landstahl Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483260
- Sponsor's protocol ID
- S-13-08
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2015
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever)
- ClinicalTrials.gov ID
- NCT02483260
- Acronym / sponsor ID
- S-13-08
- Conditions
- Viral Hemorrhagic Fever
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Product expired, new lots are not available.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is ribavirin a therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever?
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10-day course of treatment | Other | Drug: Ribavirin10-day course of treatment with follow-up 14 ± 2 days after first dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- • Has known intolerance to 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibavirinAlso: Virazole1. Loading dose, 33 mg/kg (maximum dose: 2.64 g) 2. Followed in 6 hours by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses) 3. Followed by a dose of 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 6 days (18 doses). | Drug | 10-day course of treatment |
Primary outcome
Adverse reactions
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Hawley-Molloy, MD principal investigator
Landstahl Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ribavirin in people with Viral Hemorrhagic Fever, run by U.S. Army Medical Research and Development Command at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.