At a glance
ClinicalIndex Comparison Record- ✓Confirmed hantavirus diagnosis: positive IgM assay or hantavirus detected by RT-PCR in plasma/serum during acute febrile illness <12 days duration
- ✓Hypoxia (O₂ saturation ≤92% or requiring supplemental oxygen) developing ≥1 day after symptom onset
- ✓Bilateral pulmonary infiltrates on chest X-ray
- ✓Presumptive diagnosis alternative: fever + headache/myalgia/digestive symptoms + platelets <150,000 + hypoxia + bilateral pulmonary infiltrates, all within 12 days of illness onset
- ✕Age <2 years
- ✕For presumptive diagnosis cohort: alternative respiratory or systemic infection confirmed (positive respiratory virus culture/PCR, group A Streptococcus, positive culture from sterile site, or bacterial pneumonia presentation)
- ✕Immunocompromised status (HIV, underlying malignancy, or chemotherapy/immunosuppressive drugs within 30 days)
- ✕Systemic antiviral medication (except acyclovir, famciclovir, amantadine, rimantadine) or corticosteroids ≥0.5 mg/kg prednisone equivalent within 30 days before or during treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome
In Brief
A Phase 2 clinical trial evaluating Methylprednisolone and Placebo for Hantavirus Infections. Completed, enrolled 66 participants across 1 site.
Detailed Summary
The purpose of this study is to see if a drug, called methylprednisolone, is safe and effective in people with Hantavirus infection. Individuals 2 years of age or older are invited to participate in this study if their doctor suspects or knows they have Hantavirus infection. Volunteers will either be given methylprednisolone or placebo (contains no medication) through a needle inserted in a vein for 3 days. During the first 7 days of hospitalization procedures may include blood tests, physical exams, chest x-rays, and urine tests. During study visits on days 14, 28, 84 and 180 after diagnosis, the doctors will ask about health, examine the body, take a chest X-ray, collect blood for safety testing and for measuring antibodies, and do breathing tests on volunteers. Participants will be involved in the study for about 6 months.
Study Details
Timeline
Interventions
Intravenous methylprednisolone 16 mg/kg/day for 3 days as follows: 8 mg/kg (up to 500 mg) given over first hour followed by 8 mg/kg over the next 23 hours; then 16 mg/kg (up to 1000 mg) on days 2 and 3 administered over 24 hours.
Placebo