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New treatment option for Lassa Fever
Official title ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
ClinicalTrials.gov ID: NCT06212336
What this study is testing
What is Favipiravir?
Favipiravir is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lassa fever.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- 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
You likely can't join if
- 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
See the full eligibility criteria
- General
- 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
- 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
- Sub-protocols 2.1 Favipiravir high dose sub-protocol Inclusion criteria Age ≥ 18 years old 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
- 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 Inclusion criteria
- Age ≥ 18 years old 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
- 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 Inclusion criteria Age ≥ 12 years old Exclusion criteria
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Suacoco, Bong County, Liberia
- Irrua, Edo, Nigeria
- Owo, Ondo State, Nigeria
- Bauchi, Nigeria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suacoco, Bong County, Liberia; Irrua, Edo, Nigeria; Owo, Ondo State, Nigeria; Bauchi, Nigeria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.