NCT04591613

Late Clinical Events Associated With COVID-19 Infection

Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Tourcoing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-31
• Primary completion: 2024-12-01
• Completion: 2025-08-01
• First posted: 2020-10-19
• Last updated: 2022-05-10

Locations

12 sites across 2 countries: France, French Guiana