Clinical trial NCT04817293: Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region
Official title: Coordinated Research on Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With SARS-COV-2 Infection: a Transversal Study in Town in the Hauts de France Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: he study population consisted of patients with COVID-19 infection and patients without COVID-19 infection consulting their general practitioner during the study inclusion period.

Brief summary: Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).

The objective of the COCO_Vi_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19


Eligibility criteria: Inclusion Criteria:

A- For COVID cases:

1. Consultation in a city doctor's office
2. Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
3. Patient symptomatic or not

Definition of symptomatic :

1. Anosmia
2. OR CT scan suggestive of COVID 19
3. OR ≥ 2 symptoms contemporaneous with virologic sampling among: asthenia, cough, dyspnea, fever, myalgias, dysgeusia, diarrhea AND not present previously at diagnosis

B-. For NON COVID cases:

1. Consultation in a city doctor's office
2. No known COVID+ serology
3. No known RT- PCR SARS-CoV-2
4. No clinical suspicion of COVID-19 infection

Exclusion Criteria:

1. Minor patient
2. Refusal to participate
3. Patient under protection
4. Patient requiring hospitalization for COVID-19 (excluding non-emergency hospitalization)
5. Patient consulted for the following reason only: treatment monitoring, treatment renewal or certificate, hospital discharge

Primary outcomes:
measure: To compare the reasons for consultation between patients with a history of Covid 19 and those who have not been infected with SARS-CoV-2.
timeFrame: At day 1
Secondary outcomes:
measure: To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.
timeFrame: At day 1
measure: To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.
timeFrame: At day 1
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
affiliation: CH TOURCOING
name: Olivier ROBINEAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU LILLE
name: Sophie PANAGET, MD
role: PRINCIPAL_INVESTIGATOR
References: