PA-424 The INTEGRATE study: an adaptive platform trial for the development of new interventions to combat Lassa Fever in West Africa

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Background Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. 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. Methods The INTEGRATE study is a platform, multinational, multicentre, sequential, seamless phase II-III, controlled, randomised, superiority trial in open-label parallel arms. 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. The primary endpoint is the proportion of patients presenting no clinical aggravation between D0 and D14. All hospitalized patients, including pregnant women, are eligible for enrolment. The total follow-up period is 28 days. Three interim analyses are planned, with a total study population of 218 patients per arm. A co-sponsorship will be assumed by ANRS-MIE and the Irrua Specialist Teaching Hospital (ISTH).Results Trial inclusions will begin in Nigeria in April 2024 at the Federal Medical Centre Owo and at ISTH. Other West African sites (Liberia, Benin, Guinea and Nigeria) will join the platform as they complete a site preparedness program currently undergoing. The first IMP to be evaluated will be the repurposed drug Favipiravir, compared to the SCD Ribavirin. The second IMP will probably be the antiviral ARN 75039, which has shown promising results in pre-clinical phases and is currently in phase I evaluation. Conclusion The ribavirin treatment for LF is still debated in term of safety, efficacy and affordability. The INTEGRATE study will provide evidence on new drugs efficacy in order to treat patients and reduce the burden of LF. Funding: Acknowledgment to EDCTP for funding this study.

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