Hemorrhagic FeverPhase 2NCT04283513
Treatment of Hemorrhagic Fever With Ribavirin
A Phase 2 study testing Virazole in people with Hemorrhagic Fever, run by U.S. Army Medical Research and Development Command at 1 site in Germany.
Trial summary
Multisite protocol to provide IV Ribavirin treatment to patients with probable or suspected case of Hemorrhagic Fever with Renal Syndrome (HFRS) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Fever
- What is being tested?
- Virazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 31 Oct 2022to Jul 2027
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Protocol for Adults With Hemorrhagic Fever With Renal Syndrome (HFRS) With Intravenous (IV) Ribavirin
Multisite protocol to provide IV Ribavirin treatment to patients with probable or suspected case of Hemorrhagic Fever with Renal Syndrome (HFRS)
Read the detailed description
This protocol is an open-label, single-arm, multisite protocol to provide IV ribavirin treatment to patients with probable or suspected case of HFRS. Individuals with a tentative diagnosis of HFRS will be admitted to the MTF and treated for up to 7 days with doses of IV ribavirin.
- Conditions
- Hemorrhagic Fever
- Being tested
- Virazole
- Keywords
- Hemmorrhagic Fever, 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.
VirazoleDrug
Also called IV Ribavirin
Virazole (Ribavirin), USP Injection 0.1 g/mL in a phosphate buffer solution. Each vial contains 1.2 g of Ribavirin in 12 mL
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of IV Ribavirin | Experimental | The proposed clinical dose is based on drug dosage used in the HFRS clinical trial in China that demonstrated efficacy: Loading dose, 33 mg/kg (maximum dose: 2.64 g), followed by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses), and 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 3 days (9 doses). Receives: Drug: Virazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Mortality with IV Ribavirin at 10days
Measuring the treatment effectiveness of the injected IV Ribavirin by the reduction of mortality and reported serious adverse events at the 10 days interval.
Measured: 10 Days (+/-1)
Reduction in Mortality with IV Ribavirin at 14days
Measuring the treatment effectiveness of the injected IV Ribavirin by the reduction of mortality and reported serious adverse events at the 14 days interval.
Measured: 14 Days (+/-2)
Reduction in Mortality with IV Ribavirin at 28-60days
Measuring the treatment effectiveness of the injected IV Ribavirin by the reduction of mortality and reported serious adverse events at the 28-60 days interval.
Measured: 28-60 Days
Secondary outcomes (1)
Reported Adverse Events
Number of patient reported Adverse Events
Measured: 0-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start31 Oct 2022
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Product expired, new lots not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This protocol is an open-label, single-arm, multisite protocol to provide IV ribavirin treatment to patients with probable or suspected case of Hemorrhagic Fever with Renal Syndrome (HFRS).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283513
- Sponsor's protocol ID
- S-16-01
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Treatment Protocol for Adults With Hemorrhagic Fever With Renal Syndrome (HFRS) With Intravenous (IV) Ribavirin
- ClinicalTrials.gov ID
- NCT04283513
- Acronym / sponsor ID
- S-16-01
- Conditions
- Hemorrhagic Fever
- Keywords
- Hemmorrhagic Fever, Ribavirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Product expired, new lots not available
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Feb 2020 (actual)
- 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.
Multisite protocol to provide IV Ribavirin treatment to patients with probable or suspected case of Hemorrhagic Fever with Renal Syndrome (HFRS)
Detailed description
This protocol is an open-label, single-arm, multisite protocol to provide IV ribavirin treatment to patients with probable or suspected case of HFRS. Individuals with a tentative diagnosis of HFRS will be admitted to the MTF and treated for up to 7 days with doses of IV ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This protocol is an open-label, single-arm, multisite protocol to provide IV ribavirin treatment to patients with probable or suspected case of Hemorrhagic Fever with Renal Syndrome (HFRS).
| Arm | Type | Receives |
|---|---|---|
| Efficacy of IV Ribavirin | Experimental | Drug: VirazoleThe proposed clinical dose is based on drug dosage used in the HFRS clinical trial in China that demonstrated efficacy: Loading dose, 33 mg/kg (maximum dose: 2.64 g), followed by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses), and 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 3 days (9 doses). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| VirazoleAlso: IV RibavirinVirazole (Ribavirin), USP Injection 0.1 g/mL in a phosphate buffer solution. Each vial contains 1.2 g of Ribavirin in 12 mL | Drug | Efficacy of IV Ribavirin |
Primary outcome
Reduction in Mortality with IV Ribavirin at 10days
Time frame: 10 Days (+/-1)
Measuring the treatment effectiveness of the injected IV Ribavirin by the reduction of mortality and reported serious adverse events at the 10 days interval.
Reduction in Mortality with IV Ribavirin at 14days
Time frame: 14 Days (+/-2)
Measuring the treatment effectiveness of the injected IV Ribavirin by the reduction of mortality and reported serious adverse events at the 14 days interval.
Reduction in Mortality with IV Ribavirin at 28-60days
Time frame: 28-60 Days
Measuring the treatment effectiveness of the injected IV Ribavirin by the reduction of mortality and reported serious adverse events at the 28-60 days interval.
1 secondary outcome
Reported Adverse Events
Time frame: 0-60 days
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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virazole in people with 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 13 inclusion and 13 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in Mortality with IV Ribavirin at 10days (time frame: 10 Days (+/-1)). The study lists 3 primary outcomes in all. 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.