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Covid19Predi-COVIDNCT04380987

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

An observational study of Covid19, run by Luxembourg Institute of Health at 1 site in Luxembourg.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Biological sampling
How many people
1,366 participants
Where
1 siteLuxembourg
Study dates
4 May 2020to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Luxembourg1 site

  • Luxembourg Institute of Health

    Luxembourg

Other trials in Luxembourg

About this study

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

Conditions
Covid19
Being tested
Biological sampling
Keywords
Severity factors, Patient stratification, Digital
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological samplingBiological

    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.

Study groups in NCT04380987
Study groupRoleWhat they receive
PredicovidNot described
Receives: Biological: Biological sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Description of clinical manifestations

    Number of symptoms associated with Covid-19

    Measured: 1 year

Secondary outcomes (10)

  1. Clinical aggravation of the infection

    Number of hospitalizations

    Measured: 1 year

  2. Discharge of hospitalization

    Number of discharges

    Measured: 1 year

  3. Death

    Number of deaths

    Measured: 1 year

  4. Description of biological manifestations

    Whole blood count parameters

    Measured: 1 year

  5. Description of biological manifestations

    Plasma cytokine levels

    Measured: 1 year

  6. Description of biological manifestations

    Antibodies to SARS-Cov2

    Measured: 1 year

  7. Patient-related prognostic factors

    HLA genotypes

    Measured: 1 year

  8. Patient-related prognostic factors

    Coinfections

    Measured: 1 year

  9. Virus-related prognostic factors

    Virus mutations

    Measured: 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start4 May 2020
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380987
Sponsor's protocol ID
Predi-Covid
Acronym
Predi-COVID
Status last verified
Aug 2025
First submitted
30 Apr 2020
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Luxembourg Institute of Health at 1 site in Luxembourg.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of clinical manifestations (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04380987, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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