Clinical trial NCT03889106: Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever
Official title: Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lassa Fever
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Kenema Government Hospital
name: London School of Hygiene and Tropical Medicine
name: Public Health England
First posted: 2019-03-26
Enrollment: 2
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to KGH with a positive antigen or PCR test for Lassa virus.

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.


Eligibility 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

Primary outcomes:
measure: Cardiovascular function - primary
timeFrame: Up to 28 days during hospitalisation
measure: Ribavirin PK - primary
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PD (mechanism of action) - primary
timeFrame: Up to 15 days during hospitalisation
Secondary outcomes:
measure: Cardiovascular function - secondary
timeFrame: Up to 28 days during hospitalisation
measure: Cardiovascular function - secondary
timeFrame: Up to 28 days during hospitalisation
measure: Cardiovascular function - secondary
timeFrame: Up to 28 days during hospitalisation
measure: Ribavirin PK - secondary
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PK - secondary
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PK - secondary
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PK - secondary
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PK - secondary
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PD (mechanism of action)
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PD (mechanism of action)
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PD (mechanism of action)
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PD (mechanism of action)
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PD (mechanism of action)
timeFrame: Up to 15 days during hospitalisation
measure: Ribavirin PD (mechanism of action)
timeFrame: Up to 15 days during hospitalisation
Other outcomes:
Locations:
city: Kenema
country: Sierra Leone
facility: Kenema Government Hospital
Study officials:
affiliation: University of Oxford
name: Alex Salam, MD
role: PRINCIPAL_INVESTIGATOR
References: