Covid19COCO_Vi_LATENCT04817293
Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region
An observational study of Covid19, run by Tourcoing Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Questionnaire and medical consultation
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2021to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Questionnaire, medical consultation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire SSD-12 and EQ5D5L
medical consultationOther
Medical consultation during the visit with data collection
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive | Not described Receives: Other: Questionnaire; Other: medical consultation | |
| COVID-19 negative | Not described Receives: Other: Questionnaire; Other: medical consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At day 1
Secondary outcomes (2)
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).
Measured: 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'.
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start6 Apr 2021
- Primary completionOct 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier ROBINEAU, MD, Principal investigator, CH TOURCOINGSophie PANAGET, MD, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817293
- Sponsor's protocol ID
- RIPH_2021_01
- Acronym
- COCO_Vi_LATE
- Status last verified
- May 2022
- First submitted
- 22 Mar 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04817293
- Acronym / sponsor ID
- COCO_Vi_LATE / RIPH_2021_01
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive | – | Other: Questionnaire, Other: medical consultation |
| COVID-19 negative | – | Other: Questionnaire, Other: medical consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Consultation in a city doctor's office
- Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
- Patient symptomatic or not
- Anosmia
- OR CT scan suggestive of COVID 19
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire SSD-12 and EQ5D5L | Other | COVID-19 negative, COVID-19 positive |
| medical consultationMedical consultation during the visit with data collection | Other | COVID-19 negative, COVID-19 positive |
Primary outcome
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).
2 secondary outcomes
To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.
Time frame: At day 1
To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.
Time frame: At day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier ROBINEAU, MD principal investigator
CH TOURCOING
Sophie PANAGET, MD principal investigator
CHRU LILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Tourcoing Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier ROBINEAU, MD (0320694949, orobineau@ch-tourcoing.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.