A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Patients are randomized to receive either ribavirin or a placebo for 7 days. At the completion of therapy, patients will be seen on follow-up visits on days 14, 28, and 84.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• You may be eligible for this study if you:
• • Are 12 years of age or older.
• • Are not pregnant.
• • Agree to practice sexual abstinence or use accepted barrier methods of birth control/contraception.
• • Are not breast-feeding.
• • Have a positive blood test for hantavirus.
• • Have symptoms suggestive of hantavirus illness.
• Exclusion Criteria:
• You will not be eligible for this study if you:
• • Have severe low blood count (anemia).
• • Have a diagnosis of other respiratory viruses (influenza, RSV, etc.).
• • Have group A Streptococcus with symptoms of streptococcal pharyngitis, a positive culture from a normally sterile site, or symptoms of bacterial pneumonia.
• • Are HIV positive.
• • Have cancer.
• • Have had any period of irregular heartbeat.
• • Have had chemotherapy or other drugs that suppress the immune system within 30 days.
• • Have taken by mouth or injection any antiviral drug (other than acyclovir, famciclovir, amantadine or rimantadine.)
• • Have taken by mouth or injection corticosteroids equivalent to approximately 0.5 mg/kg prednisone.
• • Have taken any experimental drug within 30 days prior to enrollment.