LAssa Fever Adjunct Treatment With DEXamethasone

NCT06222723 | Recruiting Phase 2

• 3 other identifiers: 1.0 (17 July 2023)20231908/4862023-101164-BO-ff
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lassa Fever

Outcome Measures

Primary Outcomes (1)

• Proportion of treatment emergent adverse events and treatment emergent serious adverse events

  Documentation of events

  Participants will be followed up until day 10 after enrollment.

Secondary Outcomes (10)

• Unfavourable outcome

  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

  Participants will be followed up until day 10 after enrollment.

• Description of: proinflammatory plasma cytokine levels and lymphocyte phenotype under treatment

  Participants will be followed up until day 10 after enrollment.

• Description of evolution of viral loads and infectious titers over time until day 10

  Participants will be followed up until day 10 after enrollment.

• Evolution of selected virus gene sequences under treatment

  Participants will be followed up until day 10 after enrollment.

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Standard of care antiviral ribavirin therapy

Drug: Ribavirin

Standard of care + dexamethasone

EXPERIMENTAL

Standard of care antiviral ribavirin therapy + dexamethasone

Drug: Dexamethasone; Drug: Ribavirin

Interventions

Dexamethasone DRUG

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.

Standard of care + dexamethasone

Ribavirin DRUG

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.

Standard of care; Standard of care + dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bernhard Nocht Institute for Tropical Medicine: lead

Study Sites (1)

Irrua Specialist Teaching Hospital

Irrua, Edo, Nigeria

RECRUITING

MeSH Terms

Conditions

Lassa Fever

Interventions

Dexamethasone; Ribavirin

Condition Hierarchy (Ancestors)

Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Stephan Günther, Prof.

  Bernhard Nocht Institute for Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Mirjam Groger, Dr.

CONTACT

+4940285380480; groger@bnitm.de

Stephan Günther, Prof.

CONTACT

+4940285380547; guenther@bnitm.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: January 25, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)