Lassa FeverPhase 2/3NCT06212336
ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
A Phase 2/3 study testing Favipiravir, Ribavirin and Dexamethasone in people with Lassa Fever, run by Irrua Specialist Teaching Hospital at 4 sites in 2 countries.
Trial summary
Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lassa Fever
- What is being tested?
- Favipiravir, Ribavirin and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,755 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 2 May 2025to Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical disease with signs and symptoms suggestive for LF
- Positive plasma LASV RT-PCR
- Participant requires hospitalization per the local guidelines
- Participant or their legally authorized representative is able and willing to sign the informed consent
- Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- Treatment contraindicated with favipiravir according to the Reference safety document
Show all 14Show fewer
- Pre-existing liver failure
- Severe symptomatic gout/hyperuricemia
- History of QT prolongation or arrhythmia or other cardiac disorders
- PR interval ≥ 200 ms
- Hypersensitivity to excipients
- Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- 2.2. Favipiravir-Ribavirin sub-protocol
- Age ≥ 18 years old
Who cannot join
- Unwilling to provide informed consent
- Positive pregnancy test
- Unwilling to provide informed consent
- History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document
- Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion
- Has received a vaccine against LF
Show all 25Show fewer
- Sub-protocols
- 2.1 Favipiravir high dose sub-protocol
- Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- Treatment contraindicated with favipiravir according to the Reference safety document
- Pre-existing liver failure
- Severe symptomatic gout/hyperuricemia
- History of QT prolongation or arrhythmia or other cardiac disorders
- PR interval ≥ 200 ms
- Hypersensitivity to excipients
- Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- 2.3. Dexamethasone sub-protocol
- Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- Known intolerance and contra-indications to ribavirin or dexamethasone
- Patients who already received a corticosteroid within the preceding 7 days
- 2.4 ARN-75039 subprotocols
- Exclusion criteria • History of severe gastrointestinal disease
- History of chronic generalized pruritus
- History of severe chronic liver disease
- History of severe cardiac disorder
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Nigeria3 sites, 3 recruiting
- Not yet recruiting
Abubakar Tafawa Balewa University Teaching Hospital
Bauchi
Yusuf Jibrin, Professor, +2348033940611, ybjibrin@yahoo.co.uk
Ibrahim Mahmood Maigari, Doctor, +2348061551992, immaigari@atbu.edu.ng
- Recruiting
Irrua Specialist Teaching Hospital
Irrua, Edo
Sylvanus Okogbenin, Professor, +2348060476179, okogbenins@yahoo.com
Cyril Erameh, Medical doctor
- Recruiting
Federal Medical Center Owo
Owo, Ondo State
Oladele Oluwafemi Ayodeji, Medical doctor, +2348035767632, femiayodeji@yahoo.com
Oladele Oluwafemi Ayodeji, Medical doctor
Liberia1 site, 1 recruiting
- Not yet recruiting
Phebe Hospital
Suacoco, Bong County
Minnie Sankawulo-Ricks, Doctor, +231886 523 973, msricks126@gmail.com
Minnie Sankawulo-Ricks, Doctor
About this study
Official title: Efficacy, Tolerability and Safety of New or Repurposed Drugs Against Lassa Fever in West African Countries
Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Less frequently, LASV may also be transmitted from human to human and cause nosocomial outbreaks. Ribavirin is the only treatment available with worrying toxicity, questionable efficacy and low access because of its high cost. Consequently, there is an urgent need for new drugs to treat LF patients. The Research and Development (R\&D) Blueprint of the World Health Organization (WHO) has included LF in the list of priority diseases for urgent research and development.
The INTEGRATE consortium is an unprecedented international collaboration on Lassa fever of 15 partners from 10 countries across West Africa, Europe and North America and across several disciplines (epidemiological researchers, social scientists, medical health facility professionals, humanitarian actors, etc.).
Read the detailed description
The INTEGRATE study is a platform, multinational, multicentre, sequential, seamless phase II-III, controlled, randomised, superiority trial in open-label parallel arms. Three arms will be assessed and compared to the SCD. Its primary objective is to compare the efficacy of each Investigational Medical Product (IMP) to Standard of Care Drug (SCD) to prevent death or organ failure in hospitalized patients with confirmed LF. Secondary objectives will be i) to compare the safety and tolerability of each IMP and SCD, ii) to compare the efficacy of each IMP and SCD on clinical, virological and biological parameters, iii) to describe the pharmacokinetics of each IMP and iv) to develop a pharmacokinetics / pharmacodynamics model for each IMP informing about optimal dosing regimens and dose-response relationship.
- Objectives 1.1 Primary objective The primary objective of the trial is to compare the efficacy of each IMP and SCD to prevent death or organ failure in hospitalized participants with confirmed LF. 1.2. Secondary objectives
- To compare the safety and tolerability of each IMP and SCD
- To compare the efficacy of each IMP and SCD on clinical, virological and biological parameters
- To describe the pharmacokinetics of each IMP
- To develop a pharmacokinetics / pharmacodynamics model for each IMP informing about optimal dosing regimens and dose-response relationship
- Design
- Phase II: comparative controlled design
- Phase III: Whitehead's sequential double triangular design
- Sample size: In the current version of the protocol (if all sub-protocols start at once):
- 3 IMPs go into phase III: N= 732
- 2 IMPs go into phase III: N= 585
- 1 IMP go into phase III: N= 438
- Duration
- Hospitalization: 10 days
- Follow-up: 28 days
- Conditions
- Lassa Fever
- Being tested
- Favipiravir, Ribavirin, Dexamethasone, ARN-75039 high dose, ARN-75039 low dose
- Keywords
- emerging infectious diseases, viral hemorrhagic fever, AFRICA, adult, adolescent
- Medical subject headings
- Lassa Fever, Communicable Diseases, Emerging, Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Interventional Medicinal Product (IMP)
RibavirinDrug
Also called Standard of care
Control arm
DexamethasoneDrug
Interventional Medicinal Product (IMP)
ARN-75039 high doseDrug
Investigational Medicinal Product
ARN-75039 low doseDrug
Investigational Medicinal Product
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir 1600 | Experimental | Oral favipiravir: 2400 mg BID D1; 1600 mg BID D2-D10 Receives: Drug: Favipiravir |
| Ribavirin | Active comparator | Intravenous ribavirin (Irrua regimen - 100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day) then 25 mg/kg single dose days 2-7, 12.5 mg/kg single dose days 8-10). Receives: Drug: Favipiravir |
| Favipiravir 1200 + ribavirin | Experimental | Oral favipiravir: 2400 mg BID D1; 1200 mg BID D2-D10 Intravenous ribavirin (Irrua regimen - 100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day) then 25 mg/kg single dose days 2-7, 12.5 mg/kg single dose days 8-10). Receives: Drug: Favipiravir; Drug: Ribavirin |
| Ribavirin + dexamethasone | Experimental | IV ribavirin, Irrua regimen IV or oral dexamethasone 6mg/day (For the first 48 hours, dexamethasone will be given intravenously (i. Afterwards, a switch to oral dexamethasone (same dosage) is permitted at the discretion of the study physician.) Receives: Drug: Ribavirin; Drug: Dexamethasone |
| ARN-75039 high dose | Experimental | • ARN-75039 high dose
* D1: 300mg (morning), 200mg (evening)
* D2: 200mg BID
* D3-10: 100mg BID Receives: Drug: ARN-75039 high dose |
| ARN-75039 low dose | Experimental | • ARN-75039 low dose
* D1: 150mg (morning), 100mg (evening)
* D2: 100mg BID
* D3-10: 50mg BID Receives: Drug: ARN-75039 low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Proportion of participants death definition by Y/N measure
Clinical aggravation is defined as the first occurrence of one of the following conditions, at any time point between baseline and Day 14 (included):
Death, or
Increase (+1 or +2) in the number (0, 1 or 2) of organ failures among:
Renal failure: KDIGO stage 3 Respiratory failure: SpO2/FiO2* ≤ 315 Cardiovascular failure: MBP** < 65 mmHg or SBP < 90 mmHg (measured twice with a time interval of 10 min) and lactate > 2 mmol/L Analysis per component Proportion of participants with a newly occurring component of the composite primary endpoint between Day 0 and Day 14.
Sensitivity analyses Proportion of participants presenting no clinical aggravation between baseline and Day 14, with varying thresholds on the definitions of organ failures or adding different organ failures definition (e.g. neurologic, hepatic, hematologic, etc.).
Measured: Day 28
New onset of acute kidney failure
Proportion of participants a new onset of acute kidney failure . Definition by KDIGO 3 measure. 3.0 times baseline, OR increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l).
The composite endpoint assesses the new onset of an event from D0
Measured: Between Day 0 and Day 10
New onset of acute respiratory failure
Proportion of participants a new onset of acute respiratory failure. Definition by SpO2/FiO2 ≤ 315 measure The composite endpoint assesses the new onset of an event from D0
Measured: Between Day 0 and Day 10
New onset of shock
Proportion of participants a New onset of shock. Mean Blood Pressure (MBP) < 65 mmHg or Systolic Blood Pressure (SBP) < 90 mmHg (measured twice with a time interval of 10 min) and lactate > 2 mmol/L measured at the same time The composite endpoint assesses the new onset of an event from D0
Measured: Between Day 0 and Day 10
Secondary outcomes (27)
Safety of each IMP and SCD
Proportion (events and participants with at least one event) of:
- Adverse Event* grade 3 and higher
- Serious Adverse Event
- Adverse Event of Special Interest
Measured: Between Day 0 and Day 10
Safety of each IMP and SCD
Proportion (events and participants with at least one event) of:
Adverse Event* grade 3 and higher
- Serious Adverse Event
- Adverse Event of Special Interest
Measured: Day 0, Day 28
Organ failure from composite primary endpoint
Proportion of participants with a newly occurring component of the composite primary endpoint
Measured: Between Day 0 and Day 10
New onset of Acute Kidney Injury
Proportion of participants meeting KDIGO ≥ 2 or initiation of renal replacement therapy parameters
Measured: Between Day 0 and discharge
New onset of CVPU or seizure
Proportion of participants with CVPU or seizure
Measured: Between Day 0 and Discharge
New onset of Bleeding
Proportion of participants meeting WHO bleeding scale grade 2 or above
Measured: Between Day 0 and Discharge
New onset of Severe anaemia
Proportion of participants with Hb level < 8 g/dL
Measured: Between Day 0 and Discharge
New onset of liver failure
Proportion of participants with AST or ALT ≥ 3 ULN
Measured: Between Day 0 and Discharge
New onset of clinical severity score
Proportion of participants with a NEWS2 score ≥7
Measured: Between Day 0 and Discharge
Intensive care strategies - oxygen therapy
Proportion of participants having received oxygen therapy
Measured: Between Day 0 and Discharge
Intensive care strategies - RRT
Proportion of participants having received RRT
Measured: Between Day 0 and Discharge
Intensive care strategies - blood transfusion
Proportion of participants having received blood transfusion
Measured: Between Day 0 and Discharge
Intensive care strategies- inotropes or vasopressors
Proportion of participants having received inotropes or vasopressors
Measured: Between Day 0 and Discharge
the viral clearance - Change in LF RT-PCR Ct
value (for each target gene) from D0
Measured: Day 3, Day 5, Day 7, Day 9
the viral clearance - Change in LASV viral
titer from D0
Measured: D01-D10
viral clearance - LASV RT-PCR
<LLQ
Measured: D01- D10
Pharmacokinetics (phase II only)
- Peak concentration (Cmax)
Measured: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
- Time to peak concentration (Tmax)
Measured: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
- Area under the curve
Measured: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
- Half-life
Measured: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
- Clearance
Measured: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
- Volume(s) of distribution
Measured: Between Day 0 and Day 10
PK/PD (phase II only)
- Prediction of initial viral load and slope of decline
Measured: Between Day 0 and Day 10
PK/PD (phase II only)
- Optimal dosing regimen with PK/PD modelling
Measured: Between Day 0 and Day 10
LASV RT-PCR
LASV RT-PCR (Ct value)
Measured: D28 if participants have a positive RT PCR at discharge
Peak CRP (Phase II stage only)
Peak CRP level (mg/L)
Measured: D01-D10
Time to first LASV RT-PCR <LLOQ
Time to first LASV RT-PCR <LLOQ (days)
Measured: D01-D10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start2 May 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- a) Arms Intervention/ treatement Arm 1: SCD: ribavirin Arm:2 Favirpiravir 1600 Arm 3: Favipiravir 1200+ribavirin Arm 4: Ribavirin + dexamethasone Arm 5: ARN-75039 high dose (100) Arm 6: ARN-75039 low dose (50)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,755 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irrua Specialist Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for International Medical Action, University of Bordeaux, Bernhard Nocht Institute for Tropical Medicine, Federal Medical Centre, Owo, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Fondation pour la Recherche Scientifique, Benin, Médecins Sans Frontières, Belgium, Alex Ekwueme Federal University Teaching Hospital, Donka Hospital, Conakry, Centre de Recherche Médicale de Lambaréné, University of Hamburg-Eppendorf, Phebe Hospital, Liberia, University of North Carolina, ANRS, Emerging Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Marie MD JASPARD, MD, Study director, ALIMA - The Alliance for International Medical Action - Paris, FranceSylvanus OKOGBENIN, MD, Principal investigator, Irrua Specialist Teaching Hospital Irrua - Edo State, NigeriaMichael RAMHARTER, MD, Study chair, Bernhard Nocht Institute for Tropical Medicine Bernhard-Nocht-Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212336
- Sponsor's protocol ID
- ISTH/ANRS 0409s INTEGRATE
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Tolerability and Safety of New or Repurposed Drugs Against Lassa Fever in West African Countries
- ClinicalTrials.gov ID
- NCT06212336
- Acronym / sponsor ID
- ISTH/ANRS 0409s INTEGRATE
- Conditions
- Lassa Fever
- Keywords
- emerging infectious diseases, viral hemorrhagic fever, AFRICA, adult, adolescent
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,755 participants (estimated)
- Lead sponsor
- Irrua Specialist Teaching HospitalUniversity, hospital or other
- Collaborators
- Alliance for International Medical Action, University of Bordeaux, Bernhard Nocht Institute for Tropical Medicine, Federal Medical Centre, Owo, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Fondation pour la Recherche Scientifique, Benin, Médecins Sans Frontières, Belgium, Alex Ekwueme Federal University Teaching Hospital, Donka Hospital, Conakry, Centre de Recherche Médicale de Lambaréné, University of Hamburg-Eppendorf, Phebe Hospital, Liberia, University of North Carolina, ANRS, Emerging Infectious Diseases
- Study start
- 2 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Jan 2024 (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 (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Less frequently, LASV may also be transmitted from human to human and cause nosocomial outbreaks. Ribavirin is the only treatment available with worrying toxicity, questionable efficacy and low access because of its high cost. Consequently, there is an urgent need for new drugs to treat LF patients. The Research and Development (R\&D) Blueprint of the World Health Organization (WHO) has included LF in the list of priority diseases for urgent research and development.
The INTEGRATE consortium is an unprecedented international collaboration on Lassa fever of 15 partners from 10 countries across West Africa, Europe and North America and across several disciplines (epidemiological researchers, social scientists, medical health facility professionals, humanitarian actors, etc.).
Detailed description
The INTEGRATE study is a platform, multinational, multicentre, sequential, seamless phase II-III, controlled, randomised, superiority trial in open-label parallel arms. Three arms will be assessed and compared to the SCD. Its primary objective is to compare the efficacy of each Investigational Medical Product (IMP) to Standard of Care Drug (SCD) to prevent death or organ failure in hospitalized patients with confirmed LF. Secondary objectives will be i) to compare the safety and tolerability of each IMP and SCD, ii) to compare the efficacy of each IMP and SCD on clinical, virological and biological parameters, iii) to describe the pharmacokinetics of each IMP and iv) to develop a pharmacokinetics / pharmacodynamics model for each IMP informing about optimal dosing regimens and dose-response relationship.
- Objectives 1.1 Primary objective The primary objective of the trial is to compare the efficacy of each IMP and SCD to prevent death or organ failure in hospitalized participants with confirmed LF. 1.2. Secondary objectives
- To compare the safety and tolerability of each IMP and SCD
- To compare the efficacy of each IMP and SCD on clinical, virological and biological parameters
- To describe the pharmacokinetics of each IMP
- To develop a pharmacokinetics / pharmacodynamics model for each IMP informing about optimal dosing regimens and dose-response relationship
- Design
- Phase II: comparative controlled design
- Phase III: Whitehead's sequential double triangular design
- Sample size: In the current version of the protocol (if all sub-protocols start at once):
- 3 IMPs go into phase III: N= 732
- 2 IMPs go into phase III: N= 585
- 1 IMP go into phase III: N= 438
- Duration
- Hospitalization: 10 days
- Follow-up: 28 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- a) Arms Intervention/ treatement Arm 1: SCD: ribavirin Arm:2 Favirpiravir 1600 Arm 3: Favipiravir 1200+ribavirin Arm 4: Ribavirin + dexamethasone Arm 5: ARN-75039 high dose (100) Arm 6: ARN-75039 low dose (50)
| Arm | Type | Receives |
|---|---|---|
| Favipiravir 1600 | Experimental | Drug: FavipiravirOral favipiravir: 2400 mg BID D1; 1600 mg BID D2-D10 |
| Ribavirin | Active comparator | Drug: FavipiravirIntravenous ribavirin (Irrua regimen - 100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day) then 25 mg/kg single dose days 2-7, 12.5 mg/kg single dose days 8-10). |
| Favipiravir 1200 + ribavirin | Experimental | Drug: Favipiravir, Drug: RibavirinOral favipiravir: 2400 mg BID D1; 1200 mg BID D2-D10 Intravenous ribavirin (Irrua regimen - 100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day) then 25 mg/kg single dose days 2-7, 12.5 mg/kg single dose days 8-10). |
| Ribavirin + dexamethasone | Experimental | Drug: Ribavirin, Drug: DexamethasoneIV ribavirin, Irrua regimen IV or oral dexamethasone 6mg/day (For the first 48 hours, dexamethasone will be given intravenously (i. Afterwards, a switch to oral dexamethasone (same dosage) is permitted at the discretion of the study physician.) |
| ARN-75039 high dose | Experimental | Drug: ARN-75039 high dose• ARN-75039 high dose * D1: 300mg (morning), 200mg (evening) * D2: 200mg BID * D3-10: 100mg BID |
| ARN-75039 low dose | Experimental | Drug: ARN-75039 low dose• ARN-75039 low dose * D1: 150mg (morning), 100mg (evening) * D2: 100mg BID * D3-10: 50mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- 2.2. Favipiravir-Ribavirin sub-protocol
Key exclusion criteria (25 listed)
- Sub-protocols
- 2.1 Favipiravir high dose sub-protocol
- 2.3. Dexamethasone sub-protocol
- 2.4 ARN-75039 subprotocols
- Exclusion criteria • History of severe gastrointestinal disease
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 |
|---|---|---|
| FavipiravirInterventional Medicinal Product (IMP) | Drug | Favipiravir 1200 + ribavirin, Favipiravir 1600, Ribavirin |
| RibavirinAlso: Standard of careControl arm | Drug | Favipiravir 1200 + ribavirin, Ribavirin + dexamethasone |
| DexamethasoneInterventional Medicinal Product (IMP) | Drug | Ribavirin + dexamethasone |
| ARN-75039 high doseInvestigational Medicinal Product | Drug | ARN-75039 high dose |
| ARN-75039 low doseInvestigational Medicinal Product | Drug | ARN-75039 low dose |
Primary outcome
Death
Time frame: Day 28
Proportion of participants death definition by Y/N measure Clinical aggravation is defined as the first occurrence of one of the following conditions, at any time point between baseline and Day 14 (included): Death, or Increase (+1 or +2) in the number (0, 1 or 2) of organ failures among: Renal failure: KDIGO stage 3 Respiratory failure: SpO2/FiO2* ≤ 315 Cardiovascular failure: MBP** < 65 mmHg or SBP < 90 mmHg (measured twice with a time interval of 10 min) and lactate > 2 mmol/L Analysis per component Proportion of participants with a newly occurring component of the composite primary endpoint between Day 0 and Day 14. Sensitivity analyses Proportion of participants presenting no clinical aggravation between baseline and Day 14, with varying thresholds on the definitions of organ failures or adding different organ failures definition (e.g. neurologic, hepatic, hematologic, etc.).
New onset of acute kidney failure
Time frame: Between Day 0 and Day 10
Proportion of participants a new onset of acute kidney failure . Definition by KDIGO 3 measure. 3.0 times baseline, OR increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l). The composite endpoint assesses the new onset of an event from D0
New onset of acute respiratory failure
Time frame: Between Day 0 and Day 10
Proportion of participants a new onset of acute respiratory failure. Definition by SpO2/FiO2 ≤ 315 measure The composite endpoint assesses the new onset of an event from D0
New onset of shock
Time frame: Between Day 0 and Day 10
Proportion of participants a New onset of shock. Mean Blood Pressure (MBP) < 65 mmHg or Systolic Blood Pressure (SBP) < 90 mmHg (measured twice with a time interval of 10 min) and lactate > 2 mmol/L measured at the same time The composite endpoint assesses the new onset of an event from D0
27 secondary outcomes
Safety of each IMP and SCD
Time frame: Between Day 0 and Day 10
Safety of each IMP and SCD
Time frame: Day 0, Day 28
Organ failure from composite primary endpoint
Time frame: Between Day 0 and Day 10
New onset of Acute Kidney Injury
Time frame: Between Day 0 and discharge
New onset of CVPU or seizure
Time frame: Between Day 0 and Discharge
New onset of Bleeding
Time frame: Between Day 0 and Discharge
New onset of Severe anaemia
Time frame: Between Day 0 and Discharge
New onset of liver failure
Time frame: Between Day 0 and Discharge
New onset of clinical severity score
Time frame: Between Day 0 and Discharge
Intensive care strategies - oxygen therapy
Time frame: Between Day 0 and Discharge
Intensive care strategies - RRT
Time frame: Between Day 0 and Discharge
Intensive care strategies - blood transfusion
Time frame: Between Day 0 and Discharge
Intensive care strategies- inotropes or vasopressors
Time frame: Between Day 0 and Discharge
the viral clearance - Change in LF RT-PCR Ct
Time frame: Day 3, Day 5, Day 7, Day 9
the viral clearance - Change in LASV viral
Time frame: D01-D10
viral clearance - LASV RT-PCR
Time frame: D01- D10
Pharmacokinetics (phase II only)
Time frame: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
Time frame: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
Time frame: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
Time frame: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
Time frame: Between Day 0 and Day 10
Pharmacokinetics (phase II only)
Time frame: Between Day 0 and Day 10
PK/PD (phase II only)
Time frame: Between Day 0 and Day 10
PK/PD (phase II only)
Time frame: Between Day 0 and Day 10
LASV RT-PCR
Time frame: D28 if participants have a positive RT PCR at discharge
Peak CRP (Phase II stage only)
Time frame: D01-D10
Time to first LASV RT-PCR <LLOQ
Time frame: D01-D10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Lassa Fever, Lassa Virus Infection
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.
Marie MD JASPARD, MD study director
ALIMA - The Alliance for International Medical Action - Paris, France
Sylvanus OKOGBENIN, MD principal investigator
Irrua Specialist Teaching Hospital Irrua - Edo State, Nigeria
Michael RAMHARTER, MD study chair
Bernhard Nocht Institute for Tropical Medicine Bernhard-Nocht-Hamburg, Germany
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Favipiravir, Ribavirin and Dexamethasone in people with Lassa Fever, run by Irrua Specialist Teaching Hospital at 4 sites in 2 countries.
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 14 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Nigeria, Liberia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille FRITZELL, PHD (+33 6 58 80 90 12, camille.fritzell@coral.alima.ngo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Day 28). The study lists 4 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 4 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.