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CompletedNCT04380987Predi-COVIDUpdated Sep 9, 2025

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

An observational study in Covid19, sponsored by Luxembourg Institute of Health. Completed at 1 site in Luxembourg. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Luxembourg Institute of Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,366
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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

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Conditions studied

  • Covid19

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Keywords

  • Severity factors
  • Patient stratification
  • Digital
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 1,366 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Luxembourg Institute of Health is the lead sponsor of 28 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients not understanding French or German
  • Patients already included in an interventional study on Covid-19 (Discovery or other)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,366 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Predicovid

    Biological: Biological sampling

Interventions

  • BiologicalBiological 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.

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What researchers measure

Primary outcomes

  1. Description of clinical manifestations

    Number of symptoms associated with Covid-19

    Time frame: 1 year

Secondary outcomes

  1. Clinical aggravation of the infection

    Number of hospitalizations

    Time frame: 1 year

  2. Discharge of hospitalization

    Number of discharges

    Time frame: 1 year

  3. Death

    Number of deaths

    Time frame: 1 year

  4. Description of biological manifestations

    Whole blood count parameters

    Time frame: 1 year

  5. Description of biological manifestations

    Plasma cytokine levels

    Time frame: 1 year

  6. Description of biological manifestations

    Antibodies to SARS-Cov2

    Time frame: 1 year

  7. Patient-related prognostic factors

    HLA genotypes

    Time frame: 1 year

  8. Patient-related prognostic factors

    Coinfections

    Time frame: 1 year

  9. Virus-related prognostic factors

    Virus mutations

    Time frame: 1 year

  10. 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.

    Time frame: 1 year

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Study locations

1 site
  • Luxembourg Institute of Health
    Luxembourg, Luxembourg
08

References and documents

Publications

  • Fischer A, Zhang L, Elbeji A, Wilmes P, Snoeck CJ, Larche J, Oustric P, Ollert M, Fagherazzi G. Trajectories of persisting Covid- 19 symptoms up to 24 months after acute infection: findings from the Predi-Covid cohort study. BMC Infect Dis. 2025 Apr 25;25(1):603. doi: 10.1186/s12879-025-11023-0. PubMed 40281467 ↗
  • Elbeji A, Zhang L, Higa E, Fischer A, Despotovic V, Nazarov PV, Aguayo G, Fagherazzi G. Vocal biomarker predicts fatigue in people with COVID-19: results from the prospective Predi-COVID cohort study. BMJ Open. 2022 Nov 22;12(11):e062463. doi: 10.1136/bmjopen-2022-062463. PubMed 36414294 ↗
  • 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. PubMed 36265042 ↗
  • 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. PubMed 35983269 ↗
  • 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. PubMed 35487745 ↗
  • 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. PubMed 33234656 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04380987
Lead sponsor
Luxembourg Institute of Health
Collaborators
Centre Hospitalier du Luxembourg, Hopitaux Robert Schuman (Luxembourg), Laboratoire National de Santé (Luxembourg), University of Luxembourg
Responsible party
Sponsor
First posted
May 8, 2020
Start date
May 4, 2020
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024
Last update
Sep 9, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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