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

Covid19 Clinical Trial

— Predi-COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04380987
• Other study ID #: Predi-Covid
• Status: Recruiting
• Start date: May 4, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Luxembourg Institute of Health
• Contact: Aurelie Fischer, MS
• Phone: 00352621328591
• Email: aurelie.fischer[@]lih.lu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Luxembourg	Luxembourg Institute of Health	Luxembourg

Sponsors (5)

Lead Sponsor	Collaborator
Luxembourg Institute of Health	Centre Hospitalier du Luxembourg, Hopitaux Robert Schuman (Luxembourg), Laboratoire National de Santé (Luxembourg), University of Luxembourg

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of clinical manifestations	Number of symptoms associated with Covid-19	1 year
Secondary	Clinical aggravation of the infection	Number of hospitalizations	1 year
Secondary	Discharge of hospitalization	Number of discharges	1 year
Secondary	Death	Number of deaths	1 year
Secondary	Description of biological manifestations	Whole blood count parameters	1 year
Secondary	Description of biological manifestations	Plasma cytokine levels	1 year
Secondary	Description of biological manifestations	Antibodies to SARS-Cov2	1 year
Secondary	Patient-related prognostic factors	HLA genotypes	1 year
Secondary	Patient-related prognostic factors	Coinfections	1 year
Secondary	Virus-related prognostic factors	Virus mutations	1 year
Secondary	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