Official Title
Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
Brief Summary

Several publications document the occurrence of symptoms that persist or occur late. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients. Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.

Detailed Description

Several publications document the occurrence of symptoms that persist or occur late, more
than 3 weeks after the first clinical manifestations of an SARS-COV2 infection. These
manifestations may be related to thromboembolic or inflammatory complications,
superinfections, or other mechanisms not yet well understood, including potentially related
to the persistence of SARS-COV2. The identification of the observed clinical manifestations
and their clinical and paraclinical description are essential to better understand the
natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible
late manifestations, and to identify potential management options for patients.

Since this type of event is infrequent, a large-scale national multicenter cohort study
focusing on symptomatic patients is needed. In parallel, the prevalence of the main symptoms
observed more than 3 weeks after the onset of a COVID-19 will be estimated through
partnerships with existing cohort studies in the general population or in the population
followed for COVID-19, still symptomatic or not at 3 weeks of infection.

Longitudinal implementation of bio-libraries will allow this cohort to also constitute a
bridge between clinicians and researchers.

Recruiting
COVID19

Other: Questionnaire

Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.

Other: Biocollection

Total serum, plasma samples will be collected

Other: Follow-up visit

All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.

Eligibility Criteria

Inclusion Criteria:

- History of symptomatic CoV-2-SARS infection as defined by :

o Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology

o Associated with at least one event : x Anosmia occurring after February 2020 x OR
COVID 19 evocative scanner x OR ≥ 2 contemporary symptoms of the virological sample
from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea AND not present
prior to diagnosis

- AND persistence of at least one symptom present in the first 3 weeks of a COVID-19,
more than 8 weeks away from the first symptoms of COVID-19. OR late onset of at least
one new symptom a minimum of 3 weeks and a maximum of 6 months after the first
symptoms of a CoV-2 SARS infection.

- First symptoms less than 6 months old on the day of inclusion

- To benefit from a State Health Insurance or Medical Aid plan

- Have signed an informed consent for inclusion.

Exclusion Criteria:

- Minor patient

- Patient under protection of justice

- Patient who required intensive care management :

- more than 5 days

- OR requiring orotracheal intubation

- OR having required high flow ventilation (optiflow)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
French Guiana
Locations

Ch Auxerre
Auxerre, France

CHU Caen
Caen, France

CHRU Lille
Lille, France

CH Melun Marc Jacquet
Melun, France

CH Sud Seine et Marne
Nemours, France

AP-HP Hôpital Hôtel-Dieu
Paris, France

CHU de Saint-Etienne
Saint-Priest-en-Jarez, France

CH Tourcoing
Tourcoing, France

CHRU Tours
Tours, France

CHRU Nancy
Vandœuvre-lès-Nancy, France

Centre Hospitalier Bretagne Atlantique
Vannes, France

CH André Rosemon de Cayenne
Cayenne, French Guiana

Contacts

Olivier ROBINEAU, MD PhD
0320694949
orobineau@ch-tourcoing.fr

Solange TREHOUX, PhD
0320694280
strehoux@ch-tourcoing.fr

Olivier ROBINEAU, MD PhD, Principal Investigator
CH Tourcoing

Tourcoing Hospital
NCT Number
MeSH Terms
COVID-19