Treatment of Hemorrhagic Fever With Ribavirin (NCT04283513) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Treatment of Hemorrhagic Fever With Ribavirin
Germany50 participantsStarted 2022-10-31
Plain-language summary
Multisite protocol to provide IV Ribavirin treatment to patients with probable or suspected case of Hemorrhagic Fever with Renal Syndrome (HFRS)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 be…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Mortality with IV Ribavirin at 10days
Timeframe: 10 Days (+/-1)
2
Reduction in Mortality with IV Ribavirin at 14days
Timeframe: 14 Days (+/-2)
3
Reduction in Mortality with IV Ribavirin at 28-60days
Timeframe: 28-60 Days
Trial details
NCT IDNCT04283513
SponsorU.S. Army Medical Research and Development Command