Clinical trial NCT05531773: Post COVID-19 Condition
Official title: Assessment of Post COVID-19 Manifestations in a Multicenter Cohort Study (EuCARE-POSTCOVID Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Euresist Network GEIE
Sponsor class: OTHER
Collaborators: name: ASST Santi Paolo e Carlo
name: Vilnius University Hospital Santaros Klinikos
name: Heinrich-Heine University, Duesseldorf
name: University of Rome Tor Vergata
name: Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
name: St Mary's Hospital, London
name: Centro Hospitalar Lisboa Ocidental
First posted: 2022-09-08
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

Brief 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.

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).

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.

Primary outcomes:
measure: Overall incidence of post COVID-19 condition
timeFrame: through study completion, an average of 3 years
measure: Persistence of post COVID-19 condition beyond 2-3 months from the acute COVID-19 disease
timeFrame: through study completion, an average of 3 years
measure: Predictors of post COVID-19 condition
timeFrame: through study completion, an average of 3 years
measure: Long-term organ damage (lung, heart, Central Nervous System, Peripheral Nervous System) associated with post COVID-19 condition
timeFrame: through study completion, an average of 3 years
measure: Virological and immunological phenotype of post COVID-19 condition
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital Heinrich Heine
city: Roma
country: Italy
facility: Policlinico "Tor Vergata", Università degli Studi di Roma TOR VERGATA
state: Lazio
city: Milan
country: Italy
facility: ASST Santi Paolo e Carlo
state: Lombardia
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital, Santaros Klinikos
city: Villahermosa
country: Mexico
facility: Regional Hospital Dr. Juan Graham Casasús
state: Tabasco
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental
city: London
country: United Kingdom
facility: St. Mary Hospital, Imperial College Healthcare NHS Trust
Study officials:
affiliation: ASST SANTI GIOVANNI E CARLO
name: ANTONELLA D'ARMINIO MONFORTE, PROF
role: STUDY_CHAIR
References: