Research Stefan Morreel

Abstract

This multi-country, prospective Perpetual Observational Study (POS) among patients presenting with symptoms of an acute respiratory infection (ARI) to primary care (PC) aims to provide an estimate of the overall incidence of illness and individual diagnoses, as well as critically important benchmark descriptive data related to patient characteristics, complications, outcome, and risk factors per viral aetiology. These detailed data allow for the identification of variation in management and care within and between countries, suggesting improvements for care planning and informing clinical guidelines. In the longer term, the study will establish a research-ready infrastructure for enhanced observational studies and clinical trials related to treatment, diagnosis, and prevention of ARI in the primary care setting. Such a "plug-in" approach is especially beneficial during epidemics and pandemics because it makes it possible to set up new studies much quicker, without having to go through the full process of regulatory approvals for each individual research.

Researcher(s)

• Promoter: Coenen Samuel
• Co-promoter: Morreel Stefan

Research team(s)

• Primary and interdisciplinary care Antwerp (ELIZA)

Project website

Project type(s)

• Research Project

Abstract

As the threat of multimorbidity is increasing worldwide, the enabling of integrated care focused on the quintuple aim is considered necessary. The aim of this study is to construct a data network that integrates the available Belgian data in a dynamic user-friendly dashboard for healthcare providers. Although evidence about how to integrate the principles of PHM into a fragmented healthcare system and data landscape is lacking. This project consists of three Work Packages (WPs): WP 1: Literature Search (UAntwerpen and KULeuven task) WP 2: Mocku-up Dashboard creation (UHasselt task) WP 3: WP3 Iterative Usercentred Approach (focusgroups, UAntwerpen and KULeuven task) In this way a first step of shifting from reactive to proactive and integrated care is taken to minimalize the burden of multimorbidity on the healthcare system in Belgium.

Researcher(s)

• Promoter: Morreel Stefan

Research team(s)

• Primary and interdisciplinary care Antwerp (ELIZA)

Project type(s)

• Research Project

Abstract

Background COVID-19 and COVID-like-illness cause significant ill-health and mortality, particularly in clinically vulnerable individuals. Despite novel antiviral agents coming to market, it remains imperative that the search for better treatments continues, especially since many new drugs are expensive, require a diagnostic test before they are used, and may have many important drug interactions and exclusions. An adaptive platform trial is an efficient way to test such potential agents as it allows for multiple interventions to be tested under a single master protocol. Main trial Platform randomised, double-blind, multicentre trial for the evaluation of new investigational products (IPs) for treatment of non-hospitalised patients with COVID-19 and COVID-like-illness. Platform trial A "platform trial" is a trial in which multiple IPs for the same illness can be tested simultaneously, and in which new interventions can be added during the course of the trial in accordance with pre-specified criteria. The master protocol describes the overall structure and processes of the platform, while any specifics for the interventions and comparators under investigation are described in separate intervention specific appendices (ISAs). Outcomes The primary outcome will be phase dependent. For Phase IIb/III type evaluations the primary outcome will be time to first self-report of feeling fully recovered from symptoms of COVID-19 or COVID-like-illness. For Phase IIa type evaluations the primary outcome parameter will be viral clearance and impact on biomarkers. Secondary outcomes and possible exploratory outcomes are available in the master protocol. Trial design Screening can be completed face-to face as well as remotely. After obtaining informed consent, eligibility for trial participation will be checked. Eligible participants will be randomly allocated to receive either an IP, or the specified control. Participants will be asked to report their symptoms in a daily or weekly diary. A swab will be (self)-taken at baseline (day 0) and subsequently on day 4, 7 and 14. Participants will receive a phone call on/after day 28 in case their diary is incomplete to capture a minimal outcome data set. For longer-term follow-up, all participants will receive a follow-up call or electronic questionnaire 3 and 6 months after randomisation. Trial population Participants who meet the following main inclusion criteria may be eligible to take part in the main trial: • Aged ≥18 years • Presence of at least two symptoms suggestive of COVID-19 or COVID-like-illness, one respiratory (cough, sore throat, running or congested nose or sinuses, shortness of breath) and one systemic (fever, feeling feverish, sweats/chills or shivering, low energy or tiredness, headache, muscle, joint or body aches, loss of taste and/or smell). • Judged by recruiting medically qualified clinician or research nurse that the illness is due to COVID-19 or COVID-like-illness • Onset of symptoms less than 7 days. • Willing and able to give informed consent for participation in the study. • Willing and able to comply with all trial procedures. Potential additional inclusion criteria for specific IPs will be detailed in the ISA.

Researcher(s)

• Promoter: Coenen Samuel
• Co-promoter: Morreel Stefan

Research team(s)

• Primary and interdisciplinary care Antwerp (ELIZA)

Project website

Project type(s)

• Research Project