Late Clinical Events Associated With COVID-19 Infection

  • STATUS
    Recruiting
  • End date
    Aug 5, 2022
  • participants needed
    1000
  • sponsor
    Tourcoing Hospital
Updated on 5 February 2021
Investigator
Olivier ROBINEAU, MD PhD
Primary Contact
CH Melun Marc Jacquet (9.5 mi away) Contact
+9 other location

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.

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.

Details
Condition COVID19
Treatment Questionnaire, Biocollection, Follow-up visit
Clinical Study IdentifierNCT04591613
SponsorTourcoing Hospital
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

History of symptomatic CoV-2-SARS infection as defined by
Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
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)
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