Predi-Covid
Luxembourg cohort of positive patients for COVID-19: a stratification study to predict patient prognosis
Why Predi-COVID?
In March 2020, at the beginning of the pandemic, most data in the literature came from cases in hospitals & healthcare facilities. Little information was available about the characteristics of people infected with mild or low disease severity (Why did they not develop more severe forms?) and on potential biomarkers associated with COVID-19 severity.
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Video – PREDI-COVID: Can we predict COVID-19 prognosis?
The “Predi-COVID” cohort study aims to identify important risk factors and biomarkers associated with COVID-19 severity, long-term health consequences of the disease and viral escaping natural or induced COVID-19 immunity.
FNR-grant number: 14716273
Objectives
The main objective of Predi-COVID is to identify clinical, epidemiological and omics characteristics associated with the severity of COVID-19, which will then be used to further stratify the study population into clusters of disease severity with similar pattern and disease course.
Secondary objectives:
- to study the long term health consequences of COVID-19
- to describe the trajectories of symptoms after being positively diagnosed with COVID-19
- to identify vocal biomarkers associated with respiratory syndrome and fatigue related to COVID-19, which could then further be used for easy remote monitoring of Covid-19 patients
- to monitor symptoms and disease outbreak in the high-risk population : household members
The Predi-COVID study was approved by the Luxembourgish Ministry of Health and by the National Committee for Research Ethic on April 23rd, 2020 and has been registered on Clinicaltrials.gov (NCT04380987)
The study design
Predi-COVID is a prospective hybrid cohort study composed of people positively tested for COVID-19 in Luxembourg.
All COVID-19 positive individuals diagnosed in Luxembourg can participate in the study. Initially, only adults were eligible to take part in the study, but as of February 2021, enrollment has been extended to include children.
Participation consists of monitoring symptoms and collecting general health data through e-questionnaires over 24 months (daily monitoring of symptoms and health status over 14 days, then weekly questionnaires at week 3 and 4, followed by monthly questionnaires until month 12, then at month 15 and 24). In addition, clinical and epidemiological data are collected by phone by study nurses or from the patient’s record at the hospital in case of hospitalisation.
A sub-sample of a minimum of 200 adult participants and 100 child participants are invited to participate in the deep-phenotyping sub-study (biological sampling and additional clinical and digital data collection).
The Predicovid-H ancillary study is composed of household members of positive cases included in Predi-COVID. All adults and children in the household of Predi-COVID participants are invited to participate in this study.
Participation entails the monitoring of daily symptoms and the evaluation of the health status over 14 days, as well as the evaluation of clinical and socioeconomic characteristics collected upon inclusion in the study. Biological sample collection (optional) is also foreseen (for more info : “Biobank”).
More info: “Study protocol” (in English) or Protocol – Last version (in PDF)
With the support of:
Funded by:
FNR-grant number: 14716273