Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

Sponsors

Lead sponsor: University of Oxford

Collaborator: National Institute for Health Research, United Kingdom
Kenema Government Hospital
London School of Hygiene and Tropical Medicine
Public Health England

Source University of Oxford
Brief Summary

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.

Overall Status Recruiting
Start Date March 1, 2019
Completion Date October 2020
Primary Completion Date October 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Cardiovascular function - primary Up to 28 days during hospitalisation
Ribavirin PK - primary Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) - primary Up to 15 days during hospitalisation
Secondary Outcome
Measure Time Frame
Cardiovascular function - secondary Up to 28 days during hospitalisation
Cardiovascular function - secondary Up to 28 days during hospitalisation
Cardiovascular function - secondary Up to 28 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Enrollment 100
Condition
Intervention

Intervention type: Drug

Intervention name: Ribavirin

Description: 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.

Arm group label: Lassa fever

Eligibility

Sampling method: Probability Sample

Criteria:

Inclusion Criteria:

- Positive antigen or PCR test for Lassa fever

- Aged 10 years or above

Exclusion Criteria:

- Patients for end of life care only

Gender: All

Minimum age: 10 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Alex Salam, MD Principal Investigator University of Oxford
Overall Contact

Last name: Annelies Gillesen

Phone: +441865 612959

Email: [email protected]

Location
facility status contact investigator Kenema Government Hospital Donald Grant, MD +23278350065 [email protected] Donald Grant, MD Principal Investigator
Location Countries

Sierra Leone

Verification Date

March 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Lassa fever

Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov