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 range18 Years – 65 Years
SexALL
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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…
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