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Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04817293
Acronym
COCO_Vi_LATE
Enrollment
1000
Registered
2021-03-26
Start date
2021-04-06
Completion date
2023-02-28
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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

Interventions

OTHERQuestionnaire

Questionnaire SSD-12 and EQ5D5L

Medical consultation during the visit with data collection

Sponsors

Tourcoing Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.At day 1The judgement criterion will be the reasons for consultation standardized with the CISP-2 classification (International Classification of Primary Care).

Secondary

MeasureTime frameDescription
To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.At day 1The assessment will be done using the international SSD-12 scale (Symptom Disorder-B Criteria Scale). The SSD-12 is composed of 12 items; each of the three psychological subcriteria is measured by four items (cognitive aspects; affective aspects; behavioral aspects).
To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.At day 1The EQ-5D-5L scale is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.

Countries

France

Contacts

Primary ContactOlivier ROBINEAU, MD
orobineau@ch-tourcoing.fr0320694949
Backup ContactSolange TREHOUX, PhD
strehoux@ch-tourcoing.fr0320694280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026