Luxembourg Institute of Health
Luxembourg
NCT Number: NCT04380987
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.
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Notify Me18 year and older
All sexes
Observational
Luxembourg
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
Number of symptoms associated with Covid-19
Time frame: 1 year
Number of hospitalizations
Time frame: 1 year
Number of discharges
Time frame: 1 year
Number of deaths
Time frame: 1 year
Whole blood count parameters
Time frame: 1 year
Plasma cytokine levels
Time frame: 1 year
Antibodies to SARS-Cov2
Time frame: 1 year
HLA genotypes
Time frame: 1 year
Coinfections
Time frame: 1 year
Virus mutations
Time frame: 1 year
Audio feature extracted from 30 seconds recordings of participants' voice reading a prespecified text, collected throughout the CoLIVE LIH smartphone app.
Luxembourg Institute of Health
Other Gov
Acronym: Predi-COVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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