Using Dexamethasone to Treat Lassa Fever
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
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 |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bernhard Nocht Institute for Tropical Medicine Government |
| Locations | 1 site (Irrua, Edo) |
| Trial ID | NCT06222723 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed moderate to severe Lassa fever and significant health impairment.
Not a fit: Patients who are pregnant, lactating, or have contraindications to ribavirin or dexamethasone will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from severe Lassa fever.
How similar studies have performed: While the use of dexamethasone in other infectious diseases has shown success, this specific application for Lassa fever is novel and untested.
Eligibility criteria
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 this trial is running
Irrua, Edo
- Irrua Specialist Teaching Hospital — Irrua, Edo, Nigeria (Recruiting)
Study contacts
- Study coordinator: Mirjam Groger, Dr.
- Email: groger@bnitm.de
- Phone: +4940285380480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.