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Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities

NCT00992693 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-01-02

No results posted yet for this study

Summary

This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating patients presenting with a probable or suspected case of viral hemorrhagic fever (either Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the exclusion criteria.

Conditions

  • Crimean-Congo Hemorrhagic Fever
  • Lassa Fever

Interventions

DRUG

Ribavirin (Virazole) Injection

The drug is to be administered in a volume of 50-100 ml of normal saline to be infused over 30-40 minutes. 1\) Loading dose: 33 mg/kg (maximum dose 2.64 g)(1 dose) 2) Followed by a dose of 16 mg/kg (max 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) Ten day course of treatment with follow up between day 28 to day 60.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Elizabeth Rini, MD · Landstuhl Regional Medical Center, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2016-07-19
Completion
2019-12-17

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992693 on ClinicalTrials.gov