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

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Questionnaire; Other: medical consultation

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Olivier ROBINEAU, MD; Phone Number: 0320694949; Email: orobineau@ch-tourcoing.fr

Study Locations

• France
  • Tourcoing, France
    • Recruiting
    • Ch Tourcoing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 positive	Other: Questionnaire; Questionnaire SSD-12 and EQ5D5L; Other: medical consultation; Medical consultation during the visit with data collection
COVID-19 negative	Other: Questionnaire; Questionnaire SSD-12 and EQ5D5L; Other: medical consultation; Medical consultation during the visit with data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.	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.	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

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Principal Investigator: Olivier ROBINEAU, MD, Ch Tourcoing; Principal Investigator: Sophie PANAGET, MD, CHRU Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RIPH_2021_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No