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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Nigeria
Irrua Specialist Teaching Hospital
RECRUITING
Irrua
Contact Information
Primary
Mirjam Groger, Dr.
groger@bnitm.de
+4940285380480
Backup
Stephan Günther, Prof.
guenther@bnitm.de
+4940285380547
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 42
Treatments
Active_comparator: Standard of care
Standard of care antiviral ribavirin therapy
Experimental: Standard of care + dexamethasone
Standard of care antiviral ribavirin therapy + dexamethasone
Sponsors
Leads: Bernhard Nocht Institute for Tropical Medicine

This content was sourced from clinicaltrials.gov