Protocol for a prospective, longitudinal cohort of people with COVID-19 and their household members to study factors associated with disease severity: the Predi-COVID study

Abstract

Introduction: A few major clinical factors such as sex, obesity or comorbidities have already been associated with COVID-19 severity, but there is a need to identify new epidemiological, clinical, digital and biological characteristics associated with severity and perform deep phenotyping of patients according to severity. The objectives of the Predi-COVID study are (1) to identify new determinants of COVID-19 severity and (2) to conduct deep phenotyping of patients by stratifying them according to risk of complications, as well as risk factors for infection among household members of Predi-COVID participants (the Predi-COVID-H ancillary study).

Methods and analysis: Predi-COVID is a prospective, hybrid cohort study composed of laboratory-confirmed COVID-19 cases in Luxembourg who will be followed up remotely for 1 year to monitor their health status and symptoms. Predi-COVID-H is an ancillary cohort study on household members of index cases included in Predi-COVID to monitor symptoms and household clusters in this high-risk population. A subcohort of up to 200 Predi-COVID and 300 Predi-COVID-H participants with biological samples will be included. Severity of infection will be evaluated by occurrence and duration of hospitalisation, admission and duration of stay in intensive care units or equivalent structures, provision of and duration of supplemental oxygen and ventilation therapy, transfer to another hospital, as well as the impact of infection on daily activities following hospital discharge.

Ethics and dissemination: The study has been approved by the National Research Ethics Committee of Luxembourg (study number 202003/07) in April 2020. An informed consent is signed by study participants. Scientific articles will be submitted to international peer-reviewed journals, along with press releases for lay audience for major results.

Trial registration number: NCT04380987.

Keywords: epidemiology; molecular diagnostics; public health.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Recruitment strategy in the Predi-COVID and Predi-COVID-H study.

Figure 2

Predi-COVID and Predi-COVID-H study design. CRA, clinical research associate; CRF, Case Report Form; GPS, Global Positioning System; ISARIC, International Severe Acute Respiratory and Emerging Infection Consortium; LNS, Laboratoire National de Santé.

Figure 3

Predi-COVID and Predi-COVID-H data architecture and workflow. eCRF, Electronic Case Report Form; GPS, Global Positioning System; IBBL, Integrated BioBank of Luxembourg; ISARIC, International Severe Acute Respiratory and Emerging Infection Consortium; LIH, Luxembourg Institute of Health.