eCRF for the HORFAVID Study

Research on COVID-19 has largely focused on those who develop severe or fatal disease. In recent studies, however, it has been found that an increasing number of patients with initially mild COVID-19 may experience prolonged symptoms, whose profile and time sequence remain uncertain.

The National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome therefore aimed to assess whether impaired function of the hypothalamic-pituitary-adrenal (HPA) axis and the hypothalamic-pituitary-thyroid (HPT) axis in patients with Long-COVID, is associated with fatigue.

In July 2022 INMI Spallanzani selected Livebase as the best option to record all the clinical data gathered during the HORFAVID study. The study was not sponsored by a pharmaceutical company, therefore outsourcing to a CRO was unfeasible due to budget restrictions. Crucially, Livebase allowed a single engineer to design, generate and deploy in production a fully functional scientific database for the study in just one day, which reduced its cost to a minimum.

The HORFAVID study included a sample of 104 patients attending the post-COVID-19 outpatient clinic at INMI L. Spallanzani, totaling 201 medical visits (including the follow-up visit). An autoimmunity substudy was also conducted on 12 patients selected based on certain clinical characteristics.

The eCRF designed and generated for the study collected a variety of data, including questionnaires, clinical assessments, and blood tests: for HPA axis function, cortisol ACTH, DHEAS, sodium, potassium, testosterone (for men); for HPT axis function, TSH, fT3, fT4. In addition, blood samples were taken for inflammatory study with quantification of the following cytokines on plasma: IL-1β, IL-6, TNFα, IL-8, VIT D, PCR, and D-Dimer.

Just like any application generated by Livebase, the eCRF for the HORFAVID study was based on a relational database structure. Therefore data integrity was ensured, resulting in accurate and reliable results. Moreover, the results were easy to export and share with the scientific community. Even in projects with the tightest deadlines, Livebase applications empower researchers to harness the full potential of their scientific data with ease and efficiency.