Predi-COVID is a prospective cohort study composed of people positively tested forCOVID-19 in Luxembourg, followed digitally for monitoring participants' health evolutionand symptoms at home. Participants will be actively followed for 14 days from the time ofconfirmation of diagnosis, whether they are at the hospital or at home in isolation orquarantine. Short evaluations will be also performed at week 3 and week 4 and thenmonthly for a period up to 12 months to assess potential long term consequences ofCOVID-19. A subsample of 200 participants will be contacted to integrate complementaryclinical 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 diseasemanaged at home.A deep phenotyping related to the symptoms of the disease as well as biosampling allowingfor 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