Lassa FeverNCT03889106
Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever
An observational study of Lassa Fever, run by University of Oxford at 1 site in Sierra Leone.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Lassa Fever
- What is being tested?
- Ribavirin
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteSierra Leone
- Study dates
- 1 Mar 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to KGH with a positive antigen or PCR test for Lassa virus.
Who may be able to join
- Positive antigen or PCR test for Lassa fever
- Aged 10 years or above
Who cannot join
- Patients for end of life care only
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lassa Fever
- Being tested
- Ribavirin
- Medical subject headings
- Lassa Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lassa fever | Not described Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular function - primary
Death during hospitalization
Measured: Up to 28 days during hospitalisation
Ribavirin PK - primary
Proportion of patients with ribavirin CMIN above the IC90 at all measured CMIN during therapy
Measured: 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
Measured: Up to 15 days during hospitalisation
Secondary outcomes (14)
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)
Measured: 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)
Measured: 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)
Measured: Up to 28 days during hospitalisation
Ribavirin PK - secondary
- Proportion of patients with ribavirin CMIN above the IC50 at all measured CMIN during therapy
Measured: Up to 15 days during hospitalisation
Ribavirin PK - secondary
- Peak Plasma Concentration
Measured: Up to 15 days during hospitalisation
Ribavirin PK - secondary
- Minimum Plasma Concentration
Measured: Up to 15 days during hospitalisation
Ribavirin PK - secondary
- Area under the plasma concentration versus time curve
Measured: Up to 15 days during hospitalisation
Ribavirin PK - secondary
- Half life
Measured: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
- Change in ISG expression from baseline to day 3/5
Measured: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
- Change in RHI from baseline to day 3
Measured: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
- Time to negative blood PCR for Lassa virus
Measured: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
- Survival to hospital discharge
Measured: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Change in aspartate aminotransferase concentrations (units/litre) from baseline to day 3/5
Measured: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
- Change in systemic nitric oxide concentrations from baseline to day 3/5
Measured: Up to 15 days during hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: insufficient amount of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lassa FeverStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Kenema Government Hospital, London School of Hygiene and Tropical Medicine, Public Health England
- Responsible party
- Sponsor
- Investigators
- Alex Salam, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889106
- Sponsor's protocol ID
- 38-18
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever
- ClinicalTrials.gov ID
- NCT03889106
- Acronym / sponsor ID
- 38-18
- Conditions
- Lassa Fever
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient amount of participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Kenema Government Hospital, London School of Hygiene and Tropical Medicine, Public Health England
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lassa fever | – | Drug: Ribavirin |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to KGH with a positive antigen or PCR test for Lassa virus.
Key inclusion criteria (2 listed)
- Positive antigen or PCR test for Lassa fever
- Aged 10 years or above
Key exclusion criteria (1 listed)
- Patients for end of life care only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibavirinStandard 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. | Drug | Lassa fever |
Primary outcome
Cardiovascular function - primary
Time frame: Up to 28 days during hospitalisation
Death during hospitalization
Ribavirin PK - primary
Time frame: Up to 15 days during hospitalisation
Proportion of patients with ribavirin CMIN above the IC90 at all measured CMIN during therapy
Ribavirin PD (mechanism of action) - primary
Time frame: Up to 15 days during hospitalisation
• Change in Lassa virus viral load (copies/ml) from baseline to day 3/5
14 secondary outcomes
Cardiovascular function - secondary
Time frame: Up to 28 days during hospitalisation
Cardiovascular function - secondary
Time frame: Up to 28 days during hospitalisation
Cardiovascular function - secondary
Time frame: Up to 28 days during hospitalisation
Ribavirin PK - secondary
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
Time frame: Up to 15 days during hospitalisation
Ribavirin PK - secondary
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Time frame: Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action)
Time frame: Up to 15 days during hospitalisation
Results and safety
The study was stopped early (reason given: insufficient amount of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Salam, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lassa Fever, run by University of Oxford at 1 site in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient amount of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular function - primary (time frame: Up to 28 days during hospitalisation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.