Post COVID-19 Condition

Last updated: August 28, 2024
Sponsor: Euresist Network GEIE
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

follow up of COVID-19 Patients

Clinical Study ID

NCT05531773
EuCARE - PostCOVID
  • Ages > 18
  • All Genders

Study Summary

The EuCARE-POSTCOVID study is an observational multicentre study enrolling COVID-19 patients recovered from the acute phase of disease to investigate the prevalence and possible predictors of post COVID-19 condition. The study will retrospectively analyze data already collected at the post COVID-19 outpatients services of the participating centers; furthermore, a prospective cohort study will be performed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients, >18 years old;

  • Confirmed diagnosis of COVID-19 disease (positive SARS CoV-2 RNA on naso- pharyngealswab or upper respiratory sample);

  • Mild COVID-19 disease without hospital admission or moderate/severe diseaserequiring hospital admission for COVID-19 or hospitalization for other medicalissues with a positive SARS CoV-2 RNA sample;

  • Informed consent for the study.

Exclusion

Exclusion Criteria:

  • death during hospitalization:

  • patient's decline to participate in the study.

Study Design

Total Participants: 2300
Treatment Group(s): 1
Primary Treatment: follow up of COVID-19 Patients
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
July 01, 2025

Study Description

Background:

The EuCARE project includes several cohorts of patients and schools to provide an advance response to COVID-19 epidemics. The cohorts belong to different geographic areas including European countries, Kenya, Mexico, Russia and Vietnam, and will consolidate or expand interactions with other cohorts. A comprehensive multidisciplinary team of clinicians, virologists, epidemiologists, statisticians and top experts in artificial intelligence will collaborate to investigate:

  • the natural and artificial immunity to the different viral variants in health care workers;

  • the clinical course and long-term follow up of hospitalized COVID-19 patients to derive the role of different viral variants in the outcome of the infection, including post COVID-19 condition;

  • the best strategies to control the spread of different viral variants in schools, by comparing the outcome of diverse containment and prevention measures in relation to the prevalence and dynamics of the variants.

Post COVID-19 condition is defined as the persistence or new onset of symptoms 3 months after an acute episode of COVID-19; these symptoms could last 2 or even more months and are not explained by an alternative diagnosis. The prevalence of these ongoing symptoms is very variable among the different studies, but seems high, affecting up to 50-60% of recovered patients.

Moreover, the post COVID-19 condition is described more commonly in females and more severe patients, but can be observed at all ages and in patients with a mild acute episode of COVID-19 disease.

AIMS AND OBJECTIVES The hypothesis of the study is that a relatively high proportion of patients recovered from an acute COVID-19 episode develops long-term sequelae, defined as the presence of ongoing or new onset physical and/or psychological symptoms at three months after the acute illness. These symptoms could last at least two months or even longer.

The mechanisms underpinning the post-acute and chronic manifestations of COVID-19 are not entirely understood.

The predictors of post COVID-19 condition have not yet identified, but the first evidence suggest that patients experiencing persistent symptoms, at 4-weeks or 8-weeks after the acute disease, were more likely elderly, females and hospitalized in the acute phase compared to the patients reporting symptoms for a short period of time (Carole et al, 2021).

We also hypothesized that older age, female gender, severity of disease and previous patients' comorbidities could be risk factors for the development of post COVID-19 condition.

Finally, our hypothesis is that the new variant "Omicron" could be associated with a lower inflammation and disease's severity during the acute phase and, thus, with a lower incidence of post COVID-19 condition.

Study objective:

Primary objective is to assess the incidence and risk factors of post COVID-19 condition in a cohort of recovered COVID-19 patients.

Secondary objectives are:

to evaluate the association between circulating SARS-CoV-2 variants and risk of post COVID-19 condition; to evaluate long-term residual organ damage (lung, hearth, Central Nervous System, CNS, Peripheral Nervous System, PNS) in relation to patient's characteristics and virology (variant, viral load in the acute phase).

Connect with a study center

  • University Hospital Heinrich Heine

    Düsseldorf,
    Germany

    Active - Recruiting

  • Policlinico "Tor Vergata", Università degli Studi di Roma TOR VERGATA

    Roma, Lazio
    Italy

    Active - Recruiting

  • ASST Santi Paolo e Carlo

    Milan, Lombardia
    Italy

    Active - Recruiting

  • Vilnius University Hospital, Santaros Klinikos

    Vilnius,
    Lithuania

    Active - Recruiting

  • Regional Hospital Dr. Juan Graham Casasús

    Villahermosa, Tabasco
    Mexico

    Active - Recruiting

  • Centro Hospitalar de Lisboa Ocidental

    Lisboa,
    Portugal

    Active - Recruiting

  • St. Mary Hospital, Imperial College Healthcare NHS Trust

    London,
    United Kingdom

    Active - Recruiting

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