An observational study in Lassa Fever, sponsored by University of Oxford. Terminated at 1 site in Sierra Leone. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by University of Oxford · Observational
Lassa fever carries a treated mortality in hospitalized patients of up to 50%. Lassa fever is often described as being characterized by vascular leak and shock in the terminal phase, but, whilst animal data supports this, there are limited data in humans. Therefore, an aim of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies.
Ribavirin is the current standard of care. However, the efficacy of ribavirin has not been established in a randomised controlled trial (RCT). There is very limited pharmacokinetic (PK) data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT is unknown. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Further aims of this study therefore are to characterize the PK of ribavirin in Lassa fever, and identify any associations between ribavirin PK parameters, viral load and markers of immune/inflammatory status.
University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to KGH with a positive antigen or PCR test for Lassa virus.
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:
Drug: Ribavirin
Standard of care: Intravenous administration of ribavirin at currently recommended dosages. Loading dose of 30 mg/kg (maximum 2 g), followed by 15 mg/kg (maximum 1 g) intravenously QDS for four days, followed by 7.5 mg/kg intravenously (maximum 500 mg) TDS for six days.
Cardiovascular function - primary
Death during hospitalization
Time frame: Up to 28 days during hospitalisation
Ribavirin PK - primary
Proportion of patients with ribavirin CMIN above the IC90 at all measured CMIN during therapy
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) - primary
• Change in Lassa virus viral load (copies/ml) from baseline to day 3/5
Time frame: Up to 15 days during hospitalisation
Cardiovascular function - secondary
• Shock (shock is defined as a systolic BP \< 90mmgHg \[age specific in children\] OR a MAP \< 65mmgHg AND a lactate \> 2 mEq/L)
Time frame: Up to 28 days during hospitalisation
Cardiovascular function - secondary
• Persistent shock (persistent shock is defined as a MAP \< 65 mmHg OR a SBP \< 90 mmHg \[age specific in children\] AND a lactate \> 2 mEq/L on more than 2 occasions \[at least 6 hours apart\] DESPITE IV fluids +/- vasopressors)
Time frame: Up to 28 days during hospitalisation
Cardiovascular function - secondary
• Respiratory distress (respiratory distress is defined as a respiratory rate \> 24 (age specific in children) AND oxygen saturations \< 94% OR use of supplemental oxygen)
Time frame: Up to 28 days during hospitalisation
Ribavirin PK - secondary
• Proportion of patients with ribavirin CMIN above the IC50 at all measured CMIN during therapy
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
• Peak Plasma Concentration
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
• Minimum Plasma Concentration
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
• Area under the plasma concentration versus time curve
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
• Half life
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
• Change in ISG expression from baseline to day 3/5
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
• Change in RHI from baseline to day 3
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
• Time to negative blood PCR for Lassa virus
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
• Survival to hospital discharge
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Change in aspartate aminotransferase concentrations (units/litre) from baseline to day 3/5
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
• Change in systemic nitric oxide concentrations from baseline to day 3/5
Time frame: Up to 15 days during hospitalisation
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Lassa Fever