600+ Individuals with Coronavirus Participate in Predi-COVID Cohort Study

The Luxembourg Institute of Health (LIH) has presented the preliminary results of the Luxembourgish cohort study "Predi-COVID" (full name: "Luxembourg cohort of positive patients for COVID-19: a stratification study to predict severe prognosis"); today also saw the publication of the protocol of the study in the "British Medical Journal Open".

Launched under the aegis of the Research Luxembourg COVID-19 Task Force on 24 April 2020, Predi-COVID is a cohort study promoted by the LIH that aims to identify the key risk factors and biomarkers associated with COVID-19 severity and comprehend the long-term health consequences of the disease. The study is expected to contribute to a better understanding of the heterogeneity observed in disease severity and prognosis, ultimately enabling the accurate evaluation of patients infected with SARS-CoV-2 and more personalised care recommendations. 

Predi-COVID was launched with the goal of defining which patient profiles can be associated with a more severe prognosis. The study aims to identify the clinical, epidemiological and socio-demographic characteristics, as well as specific biomarkers from both the SARS CoV-2 virus and the patient, which can help predict the way the disease will evolve in a given individual, according notably to his / her immune profile.

The research team has been establishing a cohort of people over the age of 18 who tested positive for coronavirus. All newly diagnosed individuals in Luxembourg can participate in Predi-COVID, upon agreeing to share their data for research purposes. In parallel to Predi-COVID, the ancillary study “Predi-COVID-H” was launched to include household members of COVID-19 positive participants to study the transmission of the virus in this high-risk population. The recruitment and data / sample collection phase started on 5 May and was initially planned to last until December 2020, although an extension period until late June 2021 is being requested.

The health evolution and symptoms of the enrolled patients are followed daily through different remote digital tools, depending on whether patients are at home or in hospital, for fourteen days from the time of confirmation of diagnosis. Short additional evaluations are also performed monthly for up to twelve months, to assess potential long-term consequences of COVID-19. Innovative digital data, specifically voice recordings, is also collected as part of the study. More detailed clinical and digital data and associated biological samples is gathered from a subset of at least 200 volunteers from the Predi-COVID cohort and from 100 Predi-COVID-H participants, in order to better characterise symptoms and clearly define the different outcomes. Upon inclusion in the study and after three weeks, several biological samples (including blood, nasal and oral swabs, saliva and stool) are collected from participants to identify human and viral predictive markers.

Preliminary results

Since 5 May and as of 10 November 2020, 1,406 and 67 eligible subjects have been contacted by phone for inclusion in Predi-COVID and in Predi-COVID-H, respectively, 556 of which agreed to be included in the former and 48 in the latter. On average, participants are 39 years old. In terms of biological samples, the team has been establishing a unique biobank to study COVID-19, already boasting 627 specimens collected during the baseline and follow-up visits. This collection includes blood, sputum, swabs, stool and hair samples.

The preliminary findings also indicated that the majority of the enrolled population experienced few or mild symptoms. The most prevalent symptoms at admission included fever (26.2% of participants), cough (23.3%), runny nose (12.2%) and sore throat (10.8%), while the most common comorbidities and risk factors included smoking (18.1% of participants), asthma (5.4%), diabetes (4.7%), chronic heart disease (3.6%) and obesity (3.3%).

Furthermore, a total of 3,290 voice recordings has been made available by 245 participants using the CoLive LIH smartphone app, with multiple recordings per person to allow the study of the evolution of voice characteristics over time. These will enable the identification of “vocal biomarkers” of frequently observed symptoms in COVID-19 patients, such as respiratory syndromes, fatigue, anxiety or negative emotions related to COVID-19, which could subsequently be used for the easy remote monitoring of patients at home.

“We are delighted with the results obtained thus far. We would like to encourage all individuals who recently tested positive for COVID-19 to take part in the study, since the greater the number of participants the more accurate the final results. Besides, we are now collaborating with the Centre Hospitalier de Luxembourg to envisage the inclusion of up to 100 COVID-19 positive children in Predi-COVID and up to 30 children from affected households in Predi-COVID-H”, stated Prof Markus Ollert, Director of the LIH Department of Infection and Immunity and co-Principal Investigator of Predi-COVID.

The study protocol of the study was published today, Tuesday 24 November 2020, in the "British Medical Journal Open", thus reinforcing the international visibility and success of this collaborative “Made in Luxembourg” project.

Dr Guy Fagherazzi of the LIH Department of Population Health, co-Principal Investigator of Predi-COVID and first author of the publication, added: “We are very grateful to the Health Inspection Department of the Ministry of Health for the unwavering support and excellent collaboration throughout, which are key to the success of the study. The protocol has recently been published in a renowned international journal and will serve as the core publication to cite for all future work based on Predi-COVID data. So far, nine ancillary projects funded by the National Research Fund or by the European Commission’s Horizon 2020 programme are already using Predi-COVID data”.

Predi-COVID is coordinated by the Department of Population Health (DoPH) of the LIH and boasts a highly interdisciplinary consortium of Luxembourgish research institutions, including the LIH Department of Infection and Immunity (DII), the Integrated Biobank of Luxembourg (IBBL), the Laboratoire National de Santé (LNS), the University of Luxembourg, the Luxembourg Centre for Systems Biomedicine (LCSB), the Centre Hospitalier de Luxembourg (CHL) and Hôpitaux Robert Schuman (HRS). The study is cofinanced by the Luxembourg National Research Fund (FNR) and by the André Losch Foundation.