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

NCT04817293 | Unknown

• 1 other identifier: RIPH_2021_01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

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

  At day 1

Secondary Outcomes (2)

• To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.

  At day 1

• To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.

  At day 1

Study Arms (2)

COVID-19 positive

Other: Questionnaire; Other: medical consultation

COVID-19 negative

Other: Questionnaire; Other: medical consultation

Interventions

Questionnaire OTHER

Questionnaire SSD-12 and EQ5D5L

COVID-19 negative; COVID-19 positive

medical consultation OTHER

Medical consultation during the visit with data collection

COVID-19 negative; COVID-19 positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tourcoing Hospital: lead

Study Sites (1)

CH Tourcoing

Tourcoing, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Olivier ROBINEAU, MD

  CH TOURCOING

  PRINCIPAL INVESTIGATOR

• Sophie PANAGET, MD

  CHRU LILLE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier ROBINEAU, MD

CONTACT

0320694949; orobineau@ch-tourcoing.fr

Solange TREHOUX, PhD

CONTACT

0320694280; strehoux@ch-tourcoing.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: April 6, 2021
• Primary Completion: October 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)