Covid19COCO-LATENCT04591613
Late Clinical Events Associated With COVID-19 Infection
A study testing Questionnaire, Biocollection and Follow-up visit in people with Covid19, run by Tourcoing Hospital at 12 sites in 2 countries.
Trial summary
Several publications document the occurrence of symptoms that persist or occur late. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Questionnaire, Biocollection and Follow-up visit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 31 Dec 2020to Aug 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of symptomatic CoV-2-SARS infection as defined by :
- o Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
- o Associated with at least one event : x Anosmia occurring after February 2020 x OR COVID 19 evocative scanner x OR ≥ 2 contemporary symptoms of the virological sample from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea AND not present prior to diagnosis
- AND persistence of at least one symptom present in the first 3 weeks of a COVID-19, more than 8 weeks away from the first symptoms of COVID-19. OR late onset of at least one new symptom a minimum of 3 weeks and a maximum of 6 months after the first symptoms of a CoV-2 SARS infection.
- First symptoms less than 6 months old on the day of inclusion
- To benefit from a State Health Insurance or Medical Aid plan
- Have signed an informed consent for inclusion.
Who cannot join
- Minor patient
- Patient under protection of justice
- Patient who required intensive care management :
- more than 5 days
- OR requiring orotracheal intubation
- OR having required high flow ventilation (optiflow)
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
France11 sites, 11 recruiting
- Recruiting
Ch Auxerre
Auxerre
- Recruiting
CHU Caen
Caen
- Recruiting
CHRU Lille
Lille
- Recruiting
CH Melun Marc Jacquet
Melun
- Recruiting
CH Sud Seine et Marne
Nemours
- Not yet recruiting
AP-HP Hôpital Hôtel-Dieu
Paris
- Recruiting
CHU de Saint-Etienne
Saint-Priest-en-Jarez
- Recruiting
CH Tourcoing
Tourcoing
- Recruiting
CHRU Tours
Tours
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy
- Recruiting
Centre Hospitalier Bretagne Atlantique
Vannes
French Guiana1 site, 1 recruiting
- Recruiting
CH André Rosemon de Cayenne
Cayenne
About this study
Official title: Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
Several publications document the occurrence of symptoms that persist or occur late.
The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
Read the detailed description
Several publications document the occurrence of symptoms that persist or occur late, more than 3 weeks after the first clinical manifestations of an SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory complications, superinfections, or other mechanisms not yet well understood, including potentially related to the persistence of SARS-COV2. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed. In parallel, the prevalence of the main symptoms observed more than 3 weeks after the onset of a COVID-19 will be estimated through partnerships with existing cohort studies in the general population or in the population followed for COVID-19, still symptomatic or not at 3 weeks of infection.
Longitudinal implementation of bio-libraries will allow this cohort to also constitute a bridge between clinicians and researchers.
- Conditions
- Covid19
- Being tested
- Questionnaire, Biocollection, Follow-up visit
- 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
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
BiocollectionOther
Total serum, plasma samples will be collected
Follow-up visitOther
All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
| Study group | Role | What they receive |
|---|---|---|
| Standardized clinical and paraclinical follow-up | Other | Standardized clinical and paraclinical follow-up will be offered in one of the referring investigator centers. Patients will be able to benefit from additional biological samples. Questionnaires will be completed by the patient or with the help of clinical research staff in paper format.
All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Total serum, plasma and naso-paaryngeal samples will be collected. Receives: Other: Questionnaire; Other: Biocollection; Other: Follow-up visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical description of asthenia
Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months.
Measured: At the end od the study, an average of 22 months
Clinical description of dyspnea
Frequence of dyspnea between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measured: At the end od the study, an average of 22 months
Clinical description of thoracic disorders
Frequence of thoracic disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measured: At the end od the study, an average of 22 months
Clinical description of neurological disorders
Frequence of neurological disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measured: At the end od the study, an average of 22 months
Clinical description of anosmia
Frequence of anosmia disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measured: At the end od the study, an average of 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start31 Dec 2020
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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 PhD, Principal investigator, CH TOURCOING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591613
- Sponsor's protocol ID
- RIPH_2020_09
- Acronym
- COCO-LATE
- Status last verified
- May 2022
- First submitted
- 10 Oct 2020
- 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
- Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
- ClinicalTrials.gov ID
- NCT04591613
- Acronym / sponsor ID
- COCO-LATE / RIPH_2020_09
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 19 Oct 2020 (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 symptoms that persist or occur late.
The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
Detailed description
Several publications document the occurrence of symptoms that persist or occur late, more than 3 weeks after the first clinical manifestations of an SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory complications, superinfections, or other mechanisms not yet well understood, including potentially related to the persistence of SARS-COV2. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed. In parallel, the prevalence of the main symptoms observed more than 3 weeks after the onset of a COVID-19 will be estimated through partnerships with existing cohort studies in the general population or in the population followed for COVID-19, still symptomatic or not at 3 weeks of infection.
Longitudinal implementation of bio-libraries will allow this cohort to also constitute a bridge between clinicians and researchers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized clinical and paraclinical follow-up | Other | Other: Questionnaire, Other: Biocollection, Other: Follow-up visitStandardized clinical and paraclinical follow-up will be offered in one of the referring investigator centers. Patients will be able to benefit from additional biological samples. Questionnaires will be completed by the patient or with the help of clinical research staff in paper format. All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID. Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits. Total serum, plasma and naso-paaryngeal samples will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of symptomatic CoV-2-SARS infection as defined by :
- o Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
- o Associated with at least one event : x Anosmia occurring after February 2020 x OR COVID 19 evocative scanner x OR ≥ 2 contemporary symptoms of the virological sample from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea AND not present prior to diagnosis
- AND persistence of at least one symptom present in the first 3 weeks of a COVID-19, more than 8 weeks away from the first symptoms of COVID-19. OR late onset of at least one new symptom a minimum of 3 weeks and a maximum of 6 months after the first symptoms of a CoV-2 SARS infection.
- First symptoms less than 6 months old on the day of inclusion
Key exclusion criteria (6 listed)
- Minor patient
- Patient under protection of justice
- Patient who required intensive care management :
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 |
|---|---|---|
| QuestionnaireQuality of life and chronic disease impact scales will be completed at inclusion and follow-up visits. | Other | Standardized clinical and paraclinical follow-up |
| BiocollectionTotal serum, plasma samples will be collected | Other | Standardized clinical and paraclinical follow-up |
| Follow-up visitAll patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID. | Other | Standardized clinical and paraclinical follow-up |
Primary outcome
Clinical description of asthenia
Time frame: At the end od the study, an average of 22 months
Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of dyspnea
Time frame: At the end od the study, an average of 22 months
Frequence of dyspnea between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of thoracic disorders
Time frame: At the end od the study, an average of 22 months
Frequence of thoracic disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of neurological disorders
Time frame: At the end od the study, an average of 22 months
Frequence of neurological disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of anosmia
Time frame: At the end od the study, an average of 22 months
Frequence of anosmia disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
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 PhD principal investigator
CH TOURCOING
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire, Biocollection and Follow-up visit in people with Covid19, run by Tourcoing Hospital at 12 sites in 2 countries.
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 7 inclusion and 6 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 12 sites in France, French Guiana. 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 PhD (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?
Clinical description of asthenia (time frame: At the end od the study, an average of 22 months). The study lists 5 primary outcomes in all. 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.