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

1.0 (17 July 2023)

Dexamethasone is a corticosteroid which can modulate inflammatory-mediated tissue damage associated with a wide range of infectious diseases. Dexamethasone is routinely used for treatment of tuberculous meningitis and for pneumococcal meningitis in adults. In Coronavirus Disease 2019 (COVID-19) dexamethasone is also effectively preventing immune mediated damage of the lungs. There is also indication that dexamethasone may be promising in severe LF.

2024-01-01

2026-12-01

2026-12-01

Not yet recruiting

Early phase I

42

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}

2024-01-25