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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Questionnaire; Other: Biocollection; Other: Follow-up visit

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier ROBINEAU, MD PhD; Phone Number: 0320694949; Email: orobineau@ch-tourcoing.fr

Study Locations

• France
  • Auxerre, France
    • Recruiting
    • CH Auxerre
  • Caen, France
    • Recruiting
    • CHU CAEN
  • Lille, France
    • Recruiting
    • CHRU Lille
  • Melun, France
    • Recruiting
    • CH Melun Marc Jacquet
  • Nemours, France
    • Recruiting
    • CH Sud Seine et Marne
  • Paris, France
    • Not yet recruiting
    • AP-HP Hôpital Hôtel-Dieu
  • Saint-Priest-en-Jarez, France
    • Recruiting
    • CHU de Saint-Etienne
  • Tourcoing, France
    • Recruiting
    • Ch Tourcoing
  • Tours, France
    • Recruiting
    • CHRU Tours
  • Vandœuvre-lès-Nancy, France
    • Recruiting
    • CHRU Nancy
  • Vannes, France
    • Recruiting
    • Centre hospitalier Bretagne Atlantique
• French Guiana
  • Cayenne, French Guiana
    • Recruiting
    • CH André Rosemon de Cayenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Standardized clinical and paraclinical follow-up; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Principal Investigator: Olivier ROBINEAU, MD PhD, Ch Tourcoing

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RIPH_2020_09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No