Covid19
Conditions
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.
Interventions
OTHERQuestionnaire
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
OTHERBiocollection
Total serum, plasma samples will be collected
OTHERFollow-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.
Sponsors
Tourcoing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical description of asthenia | At the end od the study, an average of 22 months | Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. |
| Clinical description of dyspnea | At the end od the study, an average of 22 months | Frequence of dyspnea between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months. |
| Clinical description of thoracic disorders | At the end od the study, an average of 22 months | Frequence of thoracic disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months. |
| Clinical description of neurological disorders | At the end od the study, an average of 22 months | Frequence of neurological disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months. |
| Clinical description of anosmia | At the end od the study, an average of 22 months | Frequence of anosmia disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months. |
Countries
France, French Guiana
Contacts
Primary ContactOlivier ROBINEAU, MD PhD
Backup ContactSolange TREHOUX, PhD
Outcome results
None listed