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

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ClinicalTrials.gov Identifier: NCT04817293
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Tourcoing Hospital

Study Description
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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


Condition or disease Intervention/treatment
Covid19 Other: Questionnaire Other: medical consultation

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: At day 1 ]
    The judgement criterion will be the reasons for consultation standardized with the CISP-2 classification (International Classification of Primary Care).


Secondary Outcome Measures :
  1. To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients. [ Time Frame: 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).

  2. To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients. [ Time Frame: 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'.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817293


Contacts
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Contact: Olivier ROBINEAU, MD 0320694949 orobineau@ch-tourcoing.fr
Contact: Solange TREHOUX, PhD 0320694280 strehoux@ch-tourcoing.fr

Locations
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France
CH Tourcoing Recruiting
Tourcoing, France
Sponsors and Collaborators
Tourcoing Hospital
Investigators
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Principal Investigator: Olivier ROBINEAU, MD CH Tourcoing
Principal Investigator: Sophie PANAGET, MD CHRU Lille
More Information
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Responsible Party: Tourcoing Hospital
ClinicalTrials.gov Identifier: NCT04817293    
Other Study ID Numbers: RIPH_2021_01
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases