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| Name | Class |
|---|---|
| Centre Hospitalier du Luxembourg | OTHER |
| Hopitaux Robert Schuman (Luxembourg) | UNKNOWN |
| Laboratoire National de Santé (Luxembourg) | UNKNOWN |
| University of Luxembourg |
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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.
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 :
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicovid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Description of clinical manifestations | Number of symptoms associated with Covid-19 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical aggravation of the infection | Number of hospitalizations | 1 year |
| Discharge of hospitalization | Number of discharges | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adult (≥18 years old) patients with confirmed SARS-CoV-2 infection, hospitalized or at home.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luxembourg Institute of Health | Luxembourg | Luxembourg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40281467 | Derived | 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. | |
| 36414294 | Derived |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| OTHER |
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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.
|
| Death | Number of deaths | 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 |
| 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. |
| 36265042 | 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. |
| 35983269 | 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. |
| 35487745 | 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. |
| 33234656 | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |