LADEX (LAssa fever adjunct treatment with DEXamethasone)

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: An open label randomized controlled phase II clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202402557039838

Enrollment

Registered

2024-02-02

Start date

2024-01-22

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lassa fever

Interventions

Standard of care plus dexamethasone

Standard of care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - LF confirmed by RT-PCR with a Ct value 3xULN o ALT (GPT) > 3xULN o KDIGO 2 or more severe based on serum creatinine only (where preceding value of creatinine is not available, the upper limit of the normal range should be used as reference) o Active macroscopic bleeding o O2 saturation < 92

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Proportion of treatment emergent adverse events and treatment emergent serious adverse events.	—

Secondary

Measure	Time frame
a) Safety and tolerability of ribavirin in moderate to severe LF b) Unfavourable outcome (composite endpoint: AKI, ARDS, shock or encephalopathy or death) c) Mean/median decline and AUC of AST, ALT, CK, LDH and CRP d) Description of proinflammatory plasma cytokine levels (e.g. IFNa, TNFa, IL-6, IL-8) and lymphocyte phenotype under treatment e) Description of evolution of viral loads and infectious titres over time until day 10. f) Evolution of selected virus gene sequences under treatment g) Population pharmacokinetics of ribavirin and dexamethasone h) Time between treatment start and hospital discharge i) Length of IMC/ICU stay j) All-cause mortality on day of discharge	—

Measure

Time frame

a) Safety and tolerability of ribavirin in moderate to severe LF b) Unfavourable outcome (composite endpoint: AKI, ARDS, shock or encephalopathy or death) c) Mean/median decline and AUC of AST, ALT, CK, LDH and CRP d) Description of proinflammatory plasma cytokine levels (e.g. IFNa, TNFa, IL-6, IL-8) and lymphocyte phenotype under treatment e) Description of evolution of viral loads and infectious titres over time until day 10. f) Evolution of selected virus gene sequences under treatment g) Population pharmacokinetics of ribavirin and dexamethasone h) Time between treatment start and hospital discharge i) Length of IMC/ICU stay j) All-cause mortality on day of discharge

—

Countries

Nigeria

Contacts

Public ContactCyril;Mirjam Erameh;Groger

Physician;Physician

cyrilerameh@gmail.com;groger@bnitm.de+2348032413382;+4940285380550

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026