Late Clinical Events Associated With COVID-19 Infection
COCO-LATE
1 other identifier
interventional
1,000
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Dec 2020
Longer than P75 for not_applicable covid19
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
December 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedMay 10, 2022
May 1, 2022
3.9 years
October 10, 2020
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Clinical description of asthenia
Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months.
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.
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.
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.
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.
At the end od the study, an average of 22 months
Study Arms (1)
Standardized clinical and paraclinical follow-up
OTHERStandardized 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.
Interventions
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Total serum, plasma samples will be collected
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.
Eligibility Criteria
You may qualify if:
- 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.
- To benefit from a State Health Insurance or Medical Aid plan
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Ch Auxerre
Auxerre, France
CHU Caen
Caen, France
CHRU Lille
Lille, France
CH Melun Marc Jacquet
Melun, France
CH Sud Seine et Marne
Nemours, France
AP-HP Hôpital Hôtel-Dieu
Paris, France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France
CH Tourcoing
Tourcoing, France
CHRU Tours
Tours, France
CHRU Nancy
Vandœuvre-lès-Nancy, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
CH André Rosemon de Cayenne
Cayenne, French Guiana
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier ROBINEAU, MD PhD
CH TOURCOING
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2020
First Posted
October 19, 2020
Study Start
December 31, 2020
Primary Completion
December 1, 2024
Study Completion
August 1, 2025
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share