A Phase 2 interventional study of Dexamethasone and Ribavirin in Lassa Fever, sponsored by Bernhard Nocht Institute for Tropical Medicine. Recruiting at 1 site in Nigeria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Bernhard Nocht Institute for Tropical Medicine · Phase 2, Interventional, and Treatment
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.
Lassa fever (LF) is a severe and often fatal systemic disease in humans. It is caused by the Lassa virus (LASV). Vaccines are not available yet and treatment options are limited to supportive care and ribavirin. Recent LF outbreaks in Nigeria showed an exceptionally high and increasing incidence of LF cases LF affects a large number of countries in West Africa. The pathophysiology of LF is not fully understood yet. It is hypothesized that the damage mediated by the host's defence is plays a key role in the pathophysiology of severe LF. Dexamethasone is considered to dampen the overactive immune response in a range of infectious diseases and thus preventing consecutive damage mediated by the host's immune system, while the antiinfective therapy is effectively treating the underlying pathogen. At the Irrua Specialist Teaching Hospital (ISTH) in Nigeria, one of the largest treatment centres for LF in West-Africa, dexamethasone has been successfully used in clinical practice to manage co-infections of LASV and Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).
To evaluate Dexamethasone for the treatment of moderate to severe LF cases, a prospective open label randomized controlled phase II clinical trial will be conducted:
The primary objective is to assess safety and tolerability of dexamethasone in moderate to severe LF when administered as adjunct treatment. Secondary objectives are to assess the effect of the study intervention on disease progression; to assess immunological and virological impact of dexamethasone therapy and the characterization of population pharmacokinetic characteristics for patients treated with adjunct dexamethasone therapy.
Bernhard Nocht Institute for Tropical Medicine is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care antiviral ribavirin therapy
Drug: Ribavirin
Standard of care antiviral ribavirin therapy + dexamethasone
Drug: Dexamethasone · Drug: Ribavirin
Dexamethasone will be administered for 10 days. For the first 48 hours, dexamethasone will be given iv. After 48 hours, a switch to oral dexamethasone (same dosage) is permitted at the discretion of the study physician.
Ribavirin treatment will be administered iv for 10 days, as recommended in the Nigeria Centre for Disease Control and Prevention National Guidelines for LF Case Management.
Proportion of treatment emergent adverse events and treatment emergent serious adverse events
Documentation of events
Time frame: Participants will be followed up until day 10 after enrollment.
Unfavourable outcome
The outcome is measured by the proportion of participants reaching a composite endpoint. The outcome is reached if there is a new onset of any of the following: acute kidney injury (KDIGO 3), acute respiratory distress syndrome (SpO2/FiO2 ≤ 315), shock (mean blood pressure \< 65 mmHg or systolic blood pressure \< 90 mmHg ), encephalopathy (CVPU or seizure), death (yes/no);
Time frame: Participants will be followed up until day 10 after enrollment.
Mean/median decline and area under the curve (AUC) of AST, ALT, CK, LDH and CRP
Blood analyses
Time frame: Participants will be followed up until day 10 after enrollment.
Description of: proinflammatory plasma cytokine levels and lymphocyte phenotype under treatment
Assays such as the enzyme-linked immunosorbent assays (ELISA) and/or immunofluorescence assays will be used to retrospectively determine LASV IgM and IgG, as well as further IgG subclassification if needed, and to monitor the development of LASV specific antibodies in blood. Longitudinal development of inflammatory biomarkers such as IFNα, TNFα, IL-6, and IL-8 will be measured in plasma using bead-based multiplex assays. The phenotype of lymphocytes will be described using flow cytometry.
Time frame: Participants will be followed up until day 10 after enrollment.
Description of evolution of viral loads and infectious titers over time until day 10
Virus titers will be determined. Viral growth, isolation of LASV in cell culture, virus sequencing and unbiased metagenomic sequencing will be used on selected samples to study the longitudinal impact of drug treatment (ribavirin and dexamethasone) on LASV genomes.
Time frame: Participants will be followed up until day 10 after enrollment.
Evolution of selected virus gene sequences under treatment
Virus sequencing
Time frame: Participants will be followed up until day 10 after enrollment.
Peak plasma concentration (Cmax)
Compartmental analysis
Time frame: Participants will be followed up until day 10 after enrollment.
Time to peak plasma concentration (Tmax)
Compartmental analysis
Time frame: Participants will be followed up until day 10 after enrollment.
Area under the plasma concentration versus time curve (AUC)
Compartmental analysis
Time frame: Participants will be followed up until day 10 after enrollment.
Half life (T 1/2)
Compartmental analysis
Time frame: Participants will be followed up until day 10 after enrollment.
Volume of distribution (Vd)
Compartmental analysis
Time frame: Participants will be followed up until day 10 after enrollment.
Plan to share: No — Case by case decision upon request
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.
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Studies of the drug tested here: Dexamethasone
Lassa Fever
Bernhard Nocht Institute for Tropical Medicine