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

The EuCARE-POSTCOVID study is an observational multicentre study enrolling COVID-19patients recovered from the acute phase of disease to investigate the prevalence andpossible predictors of post COVID-19 condition. The study will retrospectively analyzedata already collected at the post COVID-19 outpatients services of the participatingcenters; 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).

Recruiting
COVID-19

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Italy
Lithuania
Mexico
Portugal
United Kingdom
Locations

University Hospital Heinrich Heine
Düsseldorf, Germany

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

ASST Santi Paolo e Carlo
Milan, Lombardia, Italy

Vilnius University Hospital, Santaros Klinikos
Vilnius, Lithuania

Regional Hospital Dr. Juan Graham Casasús
Villahermosa, Tabasco, Mexico

Centro Hospitalar de Lisboa Ocidental
Lisboa, Portugal

St. Mary Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom

Contacts

FRANCESCA INCARDONA, DR
+393356112830
francesca.incardona@euresist.org

ANTONELLA D'ARMINIO MONFORTE, PROF
+390281843045
antonella.darminio@unimi.it

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

Euresist Network GEIE
NCT Number
MeSH Terms
COVID-19