The INTEGRATE study: an adaptive platform trial for the development of new interventions to combat Lassa Fever in West Africa.

Efficacy, tolerability and safety of new or repurposed drugs against Lassa Fever in West African countries: an adaptative phase II-III platform trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202312770983740

Enrollment

732

Registered

2023-12-22

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lassa Fever

Interventions

Ribavirin

Favipiravir 1600

Combinaison Favipiravir and Ribavirin

Combinaison Ribavirin and Dexamethasone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: General Inclusion Criteria: ? 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 Each intervention arm has specific eligibility criteria -->Favipiravir: specific inclusion criteria • Age = 18 years old -->Combinaison Favipiravir and Ribavirin specific inclusion criteria • Age = 18 years old --> Combinaison Ribavirin and Dexamethasone specific inclusion criteria • Age = 12 years old

Exclusion criteria

Exclusion criteria: General Exclusion criteria: ? Unwilling to provide informed consent ? Positive pregnancy test ? 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 Each intervention arm has have specific eligibility criteria --> Favipiravir: specific 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) --> Combinaison Favipiravir and Ribavirin specific 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) --> Combinaison Ribavirin and Dexamethasone specific 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of patients meeting any one of the components of the below composite endpoint -Death -New onset of acute kidney failure -New onset of acute respiratory failure -New onset of shock The composite endpoint assesses the new onset of an event from D0.	—

Secondary

Measure	Time frame
Safety ;Acute Kidney Injury;Encephalopathy;Bleeding;Severe anaemia;Liver failure;Clinical severity score;Intensive care strategies;Viral clearance;Pharmacokinetics (phase II only) ;PK/PD (phase II only)	—

Countries

Nigeria

Contacts

Public ContactCamille Fritzell

International Project Manager at ALIMA

camille.fritzell@coral.alima.ngo+33783676824

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026