COVID-19NCT05531773
Post COVID-19 Condition
An observational study of COVID-19, run by Euresist Network GEIE at 7 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- follow up of COVID-19 Patients
- How many people
- 2,300 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 1 Jul 2022to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- death during hospitalization:
- patient's decline to participate in the study.
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Italy2 sites, 2 recruiting
- Recruiting
ASST Santi Paolo e Carlo
Milan, Lombardy
ANTONELLA D'ARMINIO MONFORTE, PROF, +390281843045-6, antonella.darminio@unimi.it
- Recruiting
Policlinico "Tor Vergata", Università degli Studi di Roma TOR VERGATA
Rome, Lazio
FRANCESCA CECCHERINI SILBERSTEIN, PROF, CECCHERINI@med.uniroma2.it
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heinrich Heine
Düsseldorf
BJOERN JENSEN, Bjoern-ErikOle.Jensen@med.uni-duesseldorf.de
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital, Santaros Klinikos
Vilnius
DANIEL NAUMOVAS, DR, daniel.naumovas@santa.lt
Mexico1 site, 1 recruiting
- Recruiting
Regional Hospital Dr. Juan Graham Casasús
Villahermosa, Tabasco
Gibran Rubio Quintanares, DR, gibran.rubio-quintanares@uk-koeln.de
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar de Lisboa Ocidental
Lisbon
CRISTINA TOSCANO, DR, ctoscano@chlo.min-saude.pt
United Kingdom1 site, 1 recruiting
- Recruiting
St. Mary Hospital, Imperial College Healthcare NHS Trust
London
FRANCIS Drobniewski, PROF, f.drobniewski@imperial.ac.uk
About this study
Official title: 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.
Read the 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).
- Conditions
- COVID-19
- Being tested
- follow up of COVID-19 Patients
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up of COVID-19 PatientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | patients recovered from an acute COVID-19 episode Receives: Other: follow up of COVID-19 Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of post COVID-19 condition
Measured: through study completion, an average of 3 years
Persistence of post COVID-19 condition beyond 2-3 months from the acute COVID-19 disease
Measured: through study completion, an average of 3 years
Predictors of post COVID-19 condition
Measured: 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
Measured: through study completion, an average of 3 years
Virological and immunological phenotype of post COVID-19 condition
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jul 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Euresist Network GEIE
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Santi Paolo e Carlo, Vilnius University Hospital Santaros Klinikos, Heinrich-Heine University, Duesseldorf, University of Rome Tor Vergata, Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus", St Mary's Hospital, London, Centro Hospitalar Lisboa Ocidental
- Responsible party
- Sponsor
- Investigators
- ANTONELLA D'ARMINIO MONFORTE, PROF, Study chair, ASST SANTI GIOVANNI E CARLO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531773
- Sponsor's protocol ID
- EuCARE - PostCOVID
- Status last verified
- Aug 2025
- First submitted
- 6 Sep 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Varisco B, Bai F, De Benedittis S, Tavelli A, Cozzi-Lepri A, Sala M, Miraglia FG, Santoro MM, Ceccherini-Silberstein F, Shimoni Y, Ravid S, Kozlovski T, Konig F, Pfeifer N, Shamsara E, Parczewski M, Monforte AD, Incardona F, Mommo C, Marchetti G. EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations. BMC Infect Dis. 2023 Oct 13;23(1):684. doi: 10.1186/s12879-023-08595-0.
PubMed 37833640
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Post COVID-19 Manifestations in a Multicenter Cohort Study (EuCARE-POSTCOVID Study)
- ClinicalTrials.gov ID
- NCT05531773
- Acronym / sponsor ID
- EuCARE - PostCOVID
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Euresist Network GEIEUniversity, hospital or other
- Collaborators
- ASST Santi Paolo e Carlo, Vilnius University Hospital Santaros Klinikos, Heinrich-Heine University, Duesseldorf, University of Rome Tor Vergata, Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus", St Mary's Hospital, London, Centro Hospitalar Lisboa Ocidental
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Other: follow up of COVID-19 Patientspatients recovered from an acute COVID-19 episode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- death during hospitalization:
- patient's decline to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow up of COVID-19 PatientsIn 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. | Other | COVID-19 patients |
Primary outcome
Overall incidence of post COVID-19 condition
Time frame: 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
Predictors of post COVID-19 condition
Time frame: 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
Virological and immunological phenotype of post COVID-19 condition
Time frame: through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 37833640Varisco B, Bai F, De Benedittis S, Tavelli A, Cozzi-Lepri A, Sala M, Miraglia FG, Santoro MM, Ceccherini-Silberstein F, Shimoni Y, Ravid S, Kozlovski T, Konig F, Pfeifer N, Shamsara E, Parczewski M, Monforte AD, Incardona F, Mommo C, Marchetti G. EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations. BMC Infect Dis. 2023 Oct 13;23(1):684. doi: 10.1186/s12879-023-08595-0.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ANTONELLA D'ARMINIO MONFORTE, PROF study chair
ASST SANTI GIOVANNI E CARLO
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Euresist Network GEIE at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Germany, Lithuania, Mexico, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FRANCESCA INCARDONA, DR (+393356112830, francesca.incardona@euresist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of post COVID-19 condition (time frame: through study completion, an average of 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.