Clinical trial NCT04591613: Late Clinical Events Associated With COVID-19 Infection
Official title: Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Covid19
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Clinical description of asthenia
timeFrame: At the end od the study, an average of 22 months
measure: Clinical description of dyspnea
timeFrame: At the end od the study, an average of 22 months
measure: Clinical description of thoracic disorders
timeFrame: At the end od the study, an average of 22 months
measure: Clinical description of neurological disorders
timeFrame: At the end od the study, an average of 22 months
measure: Clinical description of anosmia
timeFrame: At the end od the study, an average of 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Auxerre
country: France
facility: Ch Auxerre
city: Caen
country: France
facility: CHU Caen
city: Lille
country: France
facility: CHRU Lille
city: Melun
country: France
facility: CH Melun Marc Jacquet
city: Nemours
country: France
facility: CH Sud Seine et Marne
city: Paris
country: France
facility: AP-HP Hôpital Hôtel-Dieu
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Tourcoing
country: France
facility: CH Tourcoing
city: Tours
country: France
facility: CHRU Tours
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Cayenne
country: French Guiana
facility: CH André Rosemon de Cayenne
Study officials:
affiliation: CH TOURCOING
name: Olivier ROBINEAU, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: