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Late Clinical Events Associated With COVID-19 Infection (COCO-LATE)

Primary Purpose

Covid19

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Questionnaire
Biocollection
Follow-up visit
Sponsored by
Tourcoing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • Ch AuxerreRecruiting
  • CHU CaenRecruiting
  • CHRU LilleRecruiting
  • CH Melun Marc JacquetRecruiting
  • CH Sud Seine et MarneRecruiting
  • AP-HP Hôpital Hôtel-Dieu
  • CHU de Saint-EtienneRecruiting
  • CH TourcoingRecruiting
  • CHRU ToursRecruiting
  • CHRU NancyRecruiting
  • Centre Hospitalier Bretagne AtlantiqueRecruiting
  • CH André Rosemon de CayenneRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standardized clinical and paraclinical follow-up

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical description of asthenia
Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2020
Last Updated
May 9, 2022
Sponsor
Tourcoing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04591613
Brief Title
Late Clinical Events Associated With COVID-19 Infection
Acronym
COCO-LATE
Official Title
Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tourcoing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standardized clinical and paraclinical follow-up
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Intervention Type
Other
Intervention Name(s)
Biocollection
Intervention Description
Total serum, plasma samples will be collected
Intervention Type
Other
Intervention Name(s)
Follow-up visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical description of asthenia
Description
Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months.
Time Frame
At the end od the study, an average of 22 months
Title
Clinical description of dyspnea
Description
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.
Time Frame
At the end od the study, an average of 22 months
Title
Clinical description of thoracic disorders
Description
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.
Time Frame
At the end od the study, an average of 22 months
Title
Clinical description of neurological disorders
Description
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.
Time Frame
At the end od the study, an average of 22 months
Title
Clinical description of anosmia
Description
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.
Time Frame
At the end od the study, an average of 22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier ROBINEAU, MD PhD
Phone
0320694949
Email
orobineau@ch-tourcoing.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Solange TREHOUX, PhD
Phone
0320694280
Email
strehoux@ch-tourcoing.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier ROBINEAU, MD PhD
Organizational Affiliation
CH Tourcoing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Auxerre
City
Auxerre
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Caen
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
CH Melun Marc Jacquet
City
Melun
Country
France
Individual Site Status
Recruiting
Facility Name
CH Sud Seine et Marne
City
Nemours
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hôpital Hôtel-Dieu
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU de Saint-Etienne
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Recruiting
Facility Name
CH Tourcoing
City
Tourcoing
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Nancy
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Bretagne Atlantique
City
Vannes
Country
France
Individual Site Status
Recruiting
Facility Name
CH André Rosemon de Cayenne
City
Cayenne
Country
French Guiana
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Late Clinical Events Associated With COVID-19 Infection

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