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

NCT04380987 | Completed

• 1 other identifier: Predi-Covid
• Study Type: observational
• Target: 1,366
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

Severity factors; Patient stratification; Digital

Outcome Measures

Primary Outcomes (1)

• Description of clinical manifestations

  Number of symptoms associated with Covid-19

  1 year

Secondary Outcomes (10)

• Clinical aggravation of the infection

  1 year

• Discharge of hospitalization

  1 year

• Death

  1 year

• Description of biological manifestations

  1 year

• Description of biological manifestations

  1 year

Study Arms (1)

Predicovid

Biological: Biological sampling

Interventions

Biological sampling BIOLOGICAL

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.

Predicovid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Centre Hospitalier du Luxembourg: collaborator
• Hopitaux Robert Schuman (Luxembourg): collaborator
• Laboratoire National de Santé (Luxembourg): collaborator
• University of Luxembourg: collaborator

Study Sites (1)

Luxembourg Institute of Health

Luxembourg, Luxembourg

Location

Related Publications (6)

• 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.

  PMID: 40281467 DERIVED

• 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.

  PMID: 36414294 DERIVED

• 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.

  PMID: 36265042 DERIVED

• 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.

  PMID: 35983269 DERIVED

• 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.

  PMID: 35487745 DERIVED

• 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.

  PMID: 33234656 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biological/Vaccine: 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 8, 2020
• Study Start: May 4, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

LU (1)