WP1: Establishment of a master trial protocol and related documents
The aim of Work Package 1 (WP1) is to establish a master protocol for testing the efficacy of a pan-nematode drug candidate (oxfendazole) against several filarial species as well as soil-transmitted helminths. Additionally, WP1 aims to establish the framework for initiating the study packages of the African partners.
WP2: Set-up of a joint database
Work Package 2 will establish a shared database for data management and data preparation for the analysis of the adaptive basket trial. The database will also contribute to exploring confounding factors such as geographical differences.
WP3: Clinical trial conduct and biobanking
The aim of Work Package 3 (WP3) is to set up the requirements for the conduct of 4 clinical proof-of-concept (PoC) sub-studies in Sub-Saharan Africa aimed at testing the efficacy of the pan-nematode drug candidate oxfendazole (OXF):
- PoC sub-study of OXF in onchocerciasis patients (primarily performed in the Democratic Republic of the Congo)
- PoC sub-study of OXF in loiasis patients (primarily performed in the Gabonese Republic)
- PoC sub-study of OXF in mansonellosis patients (primarily performed in the Republic of Cameroon)
- PoC sub-study of OXF in trichuriasis patients: (performed in the United Republic of Tanzania)
Additionally, WP3 will establish a biobank to store samples at the clinical trial sites.
WP4: Implementation of highly sensitive diagnostic assays
In Work Package 4, molecular diagnostic tools like LAMP (Loop-mediated Isothermal Amplification) assays will be transferred among the African partners to improve and harmonise the diagnostic expertise of the studied diseases.
WP5: Virtual training and assessment tool
In order to enhance the skills of technicians involved in the project, Work Package 5 aims to establish a virtual training platform for microscopical analysis and quality control. This platform will specifically focus on improving their proficiency in parasite detection during blood and stool examination.
WP6: Capacity building & training activities
The tools and resources offered in Work Package 6 aim to support successful clinical trials while also providing essential biomedical and clinical knowledge to scientists in low- and middle-income countries (LMICs). This includes promoting Gender Equality awareness in science and enhancing clinical trial expertise in LMICs.
WP7: Dissemination & Sustainability
The aim of WP7 is to develop communication and dissemination strategies that will ensure optimal visibility and wide outreach to relevant stakeholders. Strategic planning and implementation of project exploitation will safeguard that high-quality results are captured, assessed and used.
WP8: Project management and scientific coordination
In order to ensure that objectives and milestones are met on time, Work Package 8 will establish a well-defined organisational framework and provide clear guidance and support mechanisms to facilitate smooth project workflows.