In May 2025, the INTEGRATE clinical trial officially started first patient inclusions at one of West Africa’s leading Lassa Fever (LF) treatment centers — the Federal Medical Centre Owo (FMCO) in Nigeria. Aiming to efficiently test new Lassa fever treatment drug candidates in line with ethical and international scientific standards, this pioneering five-year study is coordinated by ALIMA in collaboration with the Bernhard Nocht Institute for Tropical Medicine (BNITM), Irrua Specialist Teaching Hospital (ISTH) and FMCO.
The INTEGRATE trial is a multinational, multicentre, controlled, randomized, adaptive phase II-III platform trial. The primary objective is to compare the efficacy of Investigational Medicinal Products (IMPs) regimen to ribavirin on prevention of death or organ failure in hospitalized participants with virologically confirmed LF. Currently, the Standard of Care Drug (SCD) is the ribavirin drug as it is recommended by the Nigeria Centre for Disease Control and Prevention (NCDC). However, the questionable effectiveness and the important toxicity of Ribavirin, and the high burden of LF in West Africa call for novel drug therapies.
First starting in Nigeria, this clinical trial will broaden to include other West African sites of the INTEGRATE consortium as soon as they are ready to include participants.
The inclusion of INTEGRATE’s first participant signals the beginning of a new chapter in the fight against Lassa fever.
“The inclusion of our first Lassa fever patient marks a pivotal step forward in our mission to improve clinical outcomes for one of West Africa’s most pressing health challenges. Through the INTEGRATE program, we aim to build a foundation of evidence that will support better treatment and ultimately save lives.”
Prof. Sylvanus Okogbenin, International Principal Investigator and physician at the ISTH.
The launch also marks a significant milestone for the INTEGRATE consortium, representing months of preparation, collaboration, and capacity building. Healthcare workers at both the ISTH and FMCO sites received intensive training in Good Clinical Practices (GCP) and in the clinical trial procedures of which participant safety procedures and data collection, ensuring readiness to begin enrolment and follow the trial protocol.
At the FMCO, where the first patient was enrolled, the significance of the moment resonated deeply with both staff and international partners.
Site Principal Investigator and physician at FMCO, Dr. Femi Ayodeji, shared the team’s sentiment;
“Welcoming the first patient into this study is a moment of deep significance for our team and our community. It reflects not only scientific progress, but also the trust patients place in us. We are committed to ensuring that their participation helps bring better care and hope to all those affected by Lassa fever.”
Echoing this sentiment, Dr. Marie Jaspard, infectious disease specialist and Coordinating International Principal Investigator, added:
“Being in Owo for the first patient inclusion was an emotional and humbling experience. I spent two hours in the ward with Dr. Ayodeji and his colleagues, witnessing first-hand the dedication of the team and the courage of the patients. After over a decade of working alongside Nigerian colleagues, this moment represents not just a scientific milestone, but a shared human commitment to confronting Lassa fever together.”
If successful, the INTEGRATE study will enable the consortium to identify an effective and safe drug that would be developed as a new treatment for Lassa fever. As the INTEGRATE clinical trial progresses, it holds the promise of transforming Lassa fever treatment through research and collaboration. With patients now being enrolled and closely monitored under a robust clinical research protocol, the consortium is taking concrete steps toward generating high-quality evidence that could pave the way for a safer and more effective treatment for Lassa fever.
“The days, months, and years leading up to the start of the INTEGRATE trial were filled with challenges. The most challenging issue being managing the multi-centre, multi-disciplinary, and multifaceted nature of the INTEGRATE consortium*. As sponsor of the INTEGRATE trial, we are grateful to our co-sponsor ANRS-MIE for their unalloyed support and tireless effort on the journey thus far, wading the storms with us. The contributions, commitment, and hard work of all our partners are most sincerely appreciated in promoting inclusion and cohesion as well as achieving this landmark start of the INTEGRATE trial.
Today, the world celebrates an important milestone in Lassa fever’s history as the trial has the prospect of providing safe and highly effective therapies for the treatment of the disease. Our team looks forward with great optimism to a successful trial that positively changes Lassa fever management globally.” added Prof. Reuben Agbons Eifediyi, Chief Medical Director, Irrua Specialist Teaching Hospital, Irrua, Edo State.
Note: Nigeria Centre for Disease Control (NCDC)