Luxembourg Cohort of Positive Patients for COVID-19: a Stratification Study to Predict Patient Prognosis (Predi-COVID)

Predi-COVID is a prospective cohort study composed of people positively tested for COVID-19 in Luxembourg, followed digitally for monitoring participants' health evolution and symptoms at home. Participants will be actively followed for 14 days from the time of confirmation of diagnosis, whether they are at the hospital or at home in isolation or quarantine. Short evaluations will be also performed at week 3 and week 4 and then monthly for a period up to 12 months to assess potential long term consequences of COVID-19. A subsample of 200 participants will be contacted to integrate complementary clinical data and collect samples.

The study aims at identifying factors associated with the COVID-19 disease severity. COVID-19 patients with severity criteria will be compared to patients with mild disease managed at home.

A deep phenotyping related to the symptoms of the disease as well as biosampling allowing for laboratory-based and computational analytics will be performed.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: Biological sampling

Detailed Description

The objective is to recruit virtually all COVID-19 positive persons in Luxembourg.

The sub-sample of a minimum of 200 COVID-19 positive persons in Predi-COVID study would allow to find a risk ratio of severe disease above 2 for the selected risk factor with a power of 80% when the prevalence of the disease is above 7%.

For every symptomatic adult tested positive by RTqPCR, biological samples will be collected at the inclusion and as follow-up 3 weeks after inclusion.

For patients at home, an experienced nurse from CIEC will perform the sampling, using all the required precautions and protections in the actual context.

For hospitalised patients, a simplified sampling strategy will be put in place and adapted to the patient state, the workload of staff and adapted constantly depending on the evolution of the epidemy.

Data will be collected through 3 different ways :

1. Questionnaires : health status monitoring data with daily questionnaires during the 14 first days following diagnosis, weekly questionnaires at week 3 and 4 and monthly questionnaires from month 2 to month 12.
2. Adapted ISARIC eCRF for patients at hospital (during all hospital stay) and at inclusion for patients included from home.
3. Smartphone application (LIH in-house solution) : innovative data (voice recordings, geolocation and mini-questionnaires).

An ancillary study will be added (Predi-COVID-H):

Predi-COVID-H is an ancillary cohort study composed of Household members of index cases to monitor symptoms and disease outbreak in this high-risk population. For every asymptomatic member of the family of a "case" included in the Predi-COVID sub-sample (a "contact"), clinical as well as socio-economic characteristics will be collected. Biological samples will also be collected at the same time as the "case" visit by nurses and up to 30 ml of blood will be taken at baseline, for serology. IgG and/or IgA seropositive "contacts" will be proposed to be enrolled in the Predi-COVID study. For IgG and IgA seronegative "contacts", a second serology will be planned 2 weeks later, up to 30 mL of blood will be collected. If they become IgG and/or IgA seropositive, they will be proposed to be enrolled in the Predi-COVID study. IgG and IgA seronegative "contacts" will be followed digitally

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Aurelie Fischer, MS; Phone Number: 00352621328591; Email: aurelie.fischer@lih.lu
• Study Contact Backup: Name: Manon Gantenbein, PhD; Email: manon.gantenbein@lih.lu

Study Locations

• Luxembourg
  • Luxembourg, Luxembourg
    • Recruiting
    • Luxembourg Institute of Health
    • Contact: Aurelie Fischer, MS; Phone Number: 00352621328591; Email: aurelie.fischer@lih.lu
    • Principal Investigator: Laetitia Huiart, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years old) patients with confirmed SARS-CoV-2 infection, hospitalized or at home.

Description

Inclusion Criteria:

• SARS-CoV-2 infection as determined by PCR, performed by one of the certified laboratories in Luxembourg
• Signed informed consent form
• Age ≥18 years old
• Hospitalized or at home

Exclusion Criteria:

• Patients not understanding French or German
• Patients already included in an interventional study on Covid-19 (Discovery or other)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Predicovid	Biological: Biological sampling; For every symptomatic adult tested positive by RTqPCR, up to 45 mL of blood will be taken, nasopharyngeal and oropharyngeal swab will be performed, an induced sputum and a stool samples will be recovered at the inclusion. As follow-up, 3 weeks after inclusion, up to 45 mL of blood will be taken and a new induced sputum will be recovered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of clinical manifestations	Number of symptoms associated with Covid-19	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Number of deaths	1 year
Clinical aggravation of the infection	Number of hospitalizations	1 year
Discharge of hospitalization	Number of discharges	1 year
Description of biological manifestations	Whole blood count parameters	1 year
Description of biological manifestations	Plasma cytokine levels	1 year
Description of biological manifestations	Antibodies to SARS-Cov2	1 year
Patient-related prognostic factors	HLA genotypes	1 year
Patient-related prognostic factors	Coinfections	1 year
Virus-related prognostic factors	Virus mutations	1 year
Vocal biomarker of Covid-19 related respiratory complications	Audio feature extracted from 30 seconds recordings of participants' voice reading a prespecified text, collected throughout the CoLIVE LIH smartphone app.	1 year

Collaborators and Investigators

• Sponsor: Luxembourg Institute of Health
• Collaborators: Centre Hospitalier du Luxembourg; University of Luxembourg; Laboratoire National de Santé (Luxembourg); Hopitaux Robert Schuman (Luxembourg)

Publications and helpful links

General Publications

• Higa E, Elbeji A, Zhang L, Fischer A, Aguayo GA, Nazarov PV, Fagherazzi G. Discovery and Analytical Validation of a Vocal Biomarker to Monitor Anosmia and Ageusia in Patients With COVID-19: Cross-sectional Study. JMIR Med Inform. 2022 Nov 8;10(11):e35622. doi: 10.2196/35622.
• Fischer A, Zhang L, Elbeji A, Wilmes P, Oustric P, Staub T, Nazarov PV, Ollert M, Fagherazzi G. Long COVID Symptomatology After 12 Months and Its Impact on Quality of Life According to Initial Coronavirus Disease 2019 Disease Severity. Open Forum Infect Dis. 2022 Aug 5;9(8):ofac397. doi: 10.1093/ofid/ofac397. eCollection 2022 Aug.
• Malisoux L, Backes A, Fischer A, Aguayo G, Ollert M, Fagherazzi G. Associations between physical activity prior to infection and COVID-19 disease severity and symptoms: results from the prospective Predi-COVID cohort study. BMJ Open. 2022 Apr 29;12(4):e057863. doi: 10.1136/bmjopen-2021-057863.
• Fagherazzi G, Fischer A, Betsou F, Vaillant M, Ernens I, Masi S, Mossong J, Staub T, Brault D, Bahlawane C, Rashid MA, Ollert M, Gantenbein M, Huiart L. 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. BMJ Open. 2020 Nov 23;10(11):e041834. doi: 10.1136/bmjopen-2020-041834.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Digital; Severity factors; Patient stratification
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Predi-Covid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No