eCRF for the RENOIR Study

RENOIR is a clinical trial that aims to evaluate the extent and persistence over time of the humoral and cellular immune response in subjects who received MAbs after SARS-CoV-2 infection and had a different vaccination status at the time of infection and evaluate the impact of different revaccination times on the humoral and cellular response.

The study is essential for understanding how specific monoclonal antibody treatments and revaccinations influence long-term immunity in COVID-19 patients. The insights gained can help optimize vaccination schedules and treatment plans, particularly for high-risk groups, thereby improving protection against severe disease outcomes, with significant implications for public health strategies.

Conducted by the National Institute for Infectious Diseases Lazzaro Spallanzani, the RENOIR study involves 93 patients aged between 18 and 65 years, with a total of 444 visits, and focuses on the durability of immune responses post-treatment and the effects of subsequent vaccinations. Investigational medicinal products (IMPs) included Evusheld, Xevudy, Comirnaty, Spikevax, and Nuvaxovid.

Without a commercial sponsor, the RENOIR study faced the challenge of limited financial resources alongside the need for a comprehensive report tool. Livebase emerged as a vital solution due to its agility and robust architecture, allowing for the rapid generation and deployment of the eCRF within a remarkably short timeframe of just three days in July 2022 by a one-man development team.

A key feature of Livebase used in the RENOIR study is its versioning capability, particularly for documenting adverse effects of the vaccines. This feature allows for systematic tracking of any changes in the documentation of vaccine side effects, which is crucial in a dynamic research environment where updates are frequent. By maintaining a detailed record of these changes, the versioning feature ensures consistency and reduces errors in reporting adverse effects.

The eCRF application designed for the RENOIR study, as any application generated with Livebase, is based upon a relational Database Management System (DBMS), offering a robust framework for exporting collected data. This structured approach ensures that the intricate datasets collected by the study are organized efficiently, enabling seamless integration with various analysis and reporting tools.