- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04817293
Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region (COCO_Vi_LATE)
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
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Olivier ROBINEAU, MD
- Telefonnummer: 0320694949
- E-mail: orobineau@ch-tourcoing.fr
Studiesteder
-
-
-
Tourcoing, Frankrig
- Rekruttering
- Ch Tourcoing
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
A- For COVID cases:
- Consultation in a city doctor's office
- Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
- Patient symptomatic or not
Definition of symptomatic :
- Anosmia
- OR CT scan suggestive of COVID 19
- 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:
- Consultation in a city doctor's office
- No known COVID+ serology
- No known RT- PCR SARS-CoV-2
- No clinical suspicion of COVID-19 infection
Exclusion Criteria:
- Minor patient
- Refusal to participate
- Patient under protection
- Patient requiring hospitalization for COVID-19 (excluding non-emergency hospitalization)
- Patient consulted for the following reason only: treatment monitoring, treatment renewal or certificate, hospital discharge
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
COVID-19 positiv
|
Questionnaire SSD-12 and EQ5D5L
Medical consultation during the visit with data collection
|
COVID-19 negativ
|
Questionnaire SSD-12 and EQ5D5L
Medical consultation during the visit with data collection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: At day 1
|
The judgement criterion will be the reasons for consultation standardized with the CISP-2 classification (International Classification of Primary Care).
|
At day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.
Tidsramme: At day 1
|
The 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).
|
At day 1
|
To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.
Tidsramme: At day 1
|
The 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'.
|
At day 1
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Olivier ROBINEAU, MD, Ch Tourcoing
- Ledende efterforsker: Sophie PANAGET, MD, CHRU Lille
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RIPH_2021_01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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