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 :
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
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.
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)
Luxembourg Institute of Health
Luxembourg, Luxembourg
Investigator: Aurelie Fischer, MS
Contact: 00352621328591
aurelie.fischer@lih.lu
Investigator: Laetitia Huiart, MD, PhD
Aurelie Fischer, MS
00352621328591
aurelie.fischer@lih.lu
Manon Gantenbein, PhD
manon.gantenbein@lih.lu