Late Clinical Events Associated With COVID-19 Infection

Covid19 Clinical Trial

— COCO-LATE  

Official title:

Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591613
• Other study ID #: RIPH_2020_09
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2020
• Est. completion date: August 2025

Study information

• Verified date: May 2022
• Source: Tourcoing Hospital
• Contact: Olivier ROBINEAU, MD PhD
• Phone: 0320694949
• Email: orobineau[@]ch-tourcoing.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Questionnaire
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
• Biocollection
Total serum, plasma samples will be collected
• Follow-up visit
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.

Locations

Country	Name	City	State
France	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
French Guiana	CH André Rosemon de Cayenne	Cayenne

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Countries where clinical trial is conducted

France,  French Guiana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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