LAssa Fever Adjunct Treatment With DEXamethasone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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:

1. Standard of care antiviral ribavirin therapy
2. Standard of care antiviral ribavirin therapy + dexamethasone

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.

Conditions

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Lassa Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care

Standard of care antiviral ribavirin therapy

Group Type ACTIVE_COMPARATOR

Ribavirin

Intervention Type 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 + dexamethasone

Standard of care antiviral ribavirin therapy + dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type 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.

Ribavirin

Intervention Type 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.

Interventions

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Dexamethasone

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.

Intervention Type DRUG

Ribavirin

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No