Post COVID-19 Condition

September 15, 2025 updated by: Euresist Network GEIE

Assessment of Post COVID-19 Manifestations in a Multicenter Cohort Study (EuCARE-POSTCOVID Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with acute COVID-19 disease from 01/03/2020 to 01/02/2025 at the participating centers will be enrolled in the study; two groups of patients recovered from acute COVID-19 will be enrolled:

  • Group 1 (hospitalized patients): patients hospitalized for COVID-19 disease;
  • Group 2 (outpatients): patients diagnosed with mild COVID-19 disease and thus not hospitalized (these patients will be referred to the Clinic of Infectious Diseases by the general practitioner or have received monoclonal antibodies for COVID-19 or antiviral treatments for COVID-19 at the Clinic of Infectious Diseases or have been visited at the Emergency Department of the hospital).

Description

Inclusion Criteria:

  • Adult patients, >18 years old;
  • Confirmed diagnosis of COVID-19 disease (positive SARS CoV-2 RNA on naso- pharyngeal swab or upper respiratory sample);
  • Mild COVID-19 disease without hospital admission or moderate/severe disease requiring hospital admission for COVID-19 or hospitalization for other medical issues with a positive SARS CoV-2 RNA sample;
  • Informed consent for the study.

Exclusion Criteria:

  • death during hospitalization:
  • patient's decline to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 patients
patients recovered from an acute COVID-19 episode
Other: follow up of COVID-19 Patients

In each participating center a post COVID-19 outpatient clinic is already working or will be settled up to care COVID-19 patients after the acute phase. At the post COVID-19 clinic patients will undergo routine blood exams and will be visited by Infectious Diseases physicians after recovery from the acute episode of COVID-19 disease. According to the clinical issues of the patients and the procedures of the study, if necessary, the patients will be visited by other practitioners (Pneumologists, Cardiologists, Neurologists, Physiatrist and Psychologists or others).

Patients who have been already visited at the post COVID outpatient clinics from 01/03/2020 and for whom data of the acute phase and the follow up have been collected will be enrolled in the study and retrospectively analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall incidence of post COVID-19 condition
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years
Persistence of post COVID-19 condition beyond 2-3 months from the acute COVID-19 disease
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years
Predictors of post COVID-19 condition
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years
Long-term organ damage (lung, heart, Central Nervous System, Peripheral Nervous System) associated with post COVID-19 condition
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years
Virological and immunological phenotype of post COVID-19 condition
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Euresist Network GEIE

Collaborators

Heinrich-Heine University, Duesseldorf
University of Rome Tor Vergata
St Mary's Hospital, London
Centro Hospitalar Lisboa Ocidental
ASST Santi Paolo e Carlo
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
Vilnius University Hospital Santaros Klinikos

Investigators

  • Study Chair: ANTONELLA D'ARMINIO MONFORTE, PROF, ASST SANTI GIOVANNI E CARLO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuCARE - PostCOVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study is part of a project funded by the European Commission and the project agreement with theCommission affirms that the data and the results will be public

IPD Sharing Time Frame

AFTER THE STUDY END NO TIME LIMIT WAS FIXED

IPD Sharing Access Criteria

REQUEST TO THE STUDY COORDINATOR OR TO THE PROJECTPARTNERS

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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