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

IntroductionA 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 analysisPredi-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 disseminationThe 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 numberNCT04380987.

Associations between physical activity prior to infection and COVID-19 disease severity and symptoms: results from the prospective Predi-COVID cohort study

“…COVID-19, caused by SARS-CoV-2, spreads rapidly from China, caused outbreaks in countries throughout the world and was characterised by the WHO as a global pandemic on 11 March 2020 1. This pandemic overwhelmed healthcare facilities, including but not limited to hospitals, intensive care units (ICUs) and outpatient facilities 2. Epidemiological studies have demonstrated that mortality is higher among the elderly population, with a 6.1% increase in mortality per 10 years increase in age 3.…”

Deep immune profiling reveals early-stage and highly coordinated immune responses in mild COVID-19 patients

“…We established the longitudinal Predi-COVID cohort 16 in Luxembourg during the first wave of the current pandemic with the aim to gain a deep and systematic understanding of the early antiviral immune response across the full spectrum of COVID-19 disease phenotypes ( Fig. 1a ).…”

“…In May 2020, a mass PCR screening program was implemented on a population-wide level in Luxembourg 30 , which allowed us to get unique access to PCR-positive asymptomatic and mild non-hospitalized COVID-19 patients and to prospectively recruit them into the longitudinal Predi-COVID study that was initiated simultaneously 16 . This empowered us to analyze a comprehensive picture of distinct early-stage protective immune signatures in mild COVID-19 patients versus hospitalized patients, asymptomatic individuals and healthy controls during the first waves of the pandemic.…”

“…Biological samples were collected at the same time as for the Predi-COVID participant sharing the house (baseline, as day 1) and 2 weeks later, at day 14. More details on the study design have been described 16 .…”

The U.S. Needs a National Human Health Observing System

“…In the U.S., the need for prospective cohort studies for COVID-19 was identified relatively early in the pandemic ( 4 ), and repurposing some ongoing longitudinal cohort studies is in process ( 23 ). In addition, a few relatively short-term prospective and retrospective cohort studies targeted to COVID-19 in specific localities are underway ( 24 , 25 ), and the National Institutes of Health (NIH) is supporting a National COVID Cohort Collaborative. The latter is to serve as “a secure portal for patient-level COVID-19 clinical data” ( 26 ), and it may be possible to utilize the All of Us national cohort study ( https://www.nih.gov/news-events/news-releases/all-us-research-program-launches-covid-19-research-initiatives ).…”