Investigating late symptoms associated with COVID-19 infection

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

This study is trying to find out what long-lasting or new symptoms people have after recovering from COVID-19 to help understand and manage these issues better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tourcoing Hospital (Academic / other)
• Locations: 12 sites (Auxerre and 11 other locations)
• Trial ID: NCT04591613 on ClinicalTrials.gov

What this trial studies

This study aims to identify and describe clinical manifestations that persist or occur late in patients who have experienced COVID-19. It focuses on symptomatic individuals who have had a confirmed SARS-CoV-2 infection and are experiencing ongoing or new symptoms more than three weeks after their initial diagnosis. The study will utilize a large-scale national multicenter cohort approach, collecting data through questionnaires and bio-samples to better understand the natural evolution of COVID-19 and its late manifestations. The findings may help clarify the underlying mechanisms of these symptoms and inform potential management strategies for affected patients.

Who should consider this trial

Good fit: Ideal candidates include adults who have had symptomatic COVID-19 and are experiencing persistent or new symptoms more than three weeks after their initial infection.

Not a fit: Patients who have not experienced any symptoms related to COVID-19 or whose symptoms have resolved completely may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of long-term symptoms associated with COVID-19.

How similar studies have performed: Other studies have documented long-term symptoms of COVID-19, indicating that this approach is relevant and necessary for understanding the condition.

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)

Where this trial is running

Auxerre and 11 other locations

• Ch Auxerre — Auxerre, France (Recruiting)
• CHU Caen — Caen, France (Recruiting)
• CHRU Lille — Lille, France (Recruiting)
• CH Melun Marc Jacquet — Melun, France (Recruiting)
• CH Sud Seine et Marne — Nemours, France (Recruiting)
• AP-HP Hôpital Hôtel-Dieu — Paris, France (Not_yet_recruiting)
• CHU de Saint-Etienne — Saint-Priest-en-Jarez, France (Recruiting)
• CH Tourcoing — Tourcoing, France (Recruiting)
• CHRU Tours — Tours, France (Recruiting)
• CHRU Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
• Centre Hospitalier Bretagne Atlantique — Vannes, France (Recruiting)
• CH André Rosemon de Cayenne — Cayenne, French Guiana (Recruiting)

Study contacts

• Principal investigator: Olivier ROBINEAU, MD PhD — Ch Tourcoing
• Study coordinator: Olivier ROBINEAU, MD PhD

Conditions Covid19