Using Dexamethasone to Treat Lassa Fever
Official title: Safety and Tolerability of Adjunct Dexamethasone in Addition to Standard of Care Antiviral Therapy Compared to Standard of Care Antiviral Therapy Alone for the Treatment of Moderate to Severe Lassa Fever
Run by Bernhard Nocht Institute for Tropical Medicine · NCT06222723 · Data updated 2026-11-12
This study is testing if adding dexamethasone to the standard treatment for moderate to severe Lassa fever can help patients feel better and recover more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Bernhard Nocht Institute for Tropical Medicine Government |
| Locations | 1 site (Irrua, Edo) |
| Status | Recruiting |
| Started | February 5, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | February 6, 2025 |
| Trial ID | NCT06222723 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with confirmed moderate to severe Lassa fever and significant health impairment.
✕Probably not a fit
Patients who are pregnant, lactating, or have contraindications to ribavirin or dexamethasone will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and tolerability of dexamethasone as an adjunct treatment for moderate to severe Lassa fever, alongside standard antiviral therapy with ribavirin. The study is a prospective open-label randomized controlled trial conducted at the Irrua Specialist Teaching Hospital in Nigeria, where dexamethasone has shown promise in managing co-infections. Participants will be randomly assigned to receive either ribavirin alone or ribavirin plus dexamethasone to assess the potential benefits of the corticosteroid in reducing immune-mediated damage associated with the disease.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from severe Lassa fever.
How similar studies have gone: While the use of dexamethasone in other infectious diseases has shown success, this specific application for Lassa fever is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * LF confirmed by RT-PCR (reverse-transcription polymerase chain reaction) with a cycle threshold (Ct) value \< 30 * Signs of significant health impairment as evidenced by any of the following: * Alert, confusion, voice, pain, unresponsive (ACVPU) other than A * Systolic blood pressure \< 90 mmHg * Seizure(s), meningism, coma, focal neurological deficit * AST (GOT) \>3xULN * ALT (GPT) \> 3xULN * KDIGO 2 or more severe based on serum creatinine only * Active macroscopic bleeding * O2 saturation \< 92 Exclusion Criteria: * Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential) * Lactation following live birth * Known intolerance and contra-indications to ribavirin or dexamethasone * Patients who already received a corticosteroid within the preceding 7 days * Investigator's valuation that patient might be put to substantial risk by participating in this trial * Patients receiving end-of-life care as judged by the investigator
Where it's running
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Irrua Specialist Teaching Hospital
Irrua, Edo, Nigeria Recruiting
Study contacts
- Study coordinator: Mirjam Groger, Dr.
- Email: groger@bnitm.de
- Phone: +4940285380480
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.