Post COVID-19 Condition

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531773
• Other study ID #: EuCARE - PostCOVID
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: September 2022
• Source: Euresist Network GEIE
• Contact: FRANCESCA INCARDONA, DR
• Phone: +393356112830
• Email: francesca.incardona[@]euresist.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Heinrich Heine	Düsseldorf
Italy	ASST Santi Paolo e Carlo	Milan	Lombardia
Italy	Policlinico "Tor Vergata", Università degli Studi di Roma TOR VERGATA	Roma	Lazio
Lithuania	Vilnius University Hospital, Santaros Klinikos	Vilnius
Mexico	Regional Hospital Dr. Juan Graham Casasús	Villahermosa	Tabasco
Portugal	Centro Hospitalar de Lisboa Ocidental	Lisboa
United Kingdom	St. Mary Hospital, Imperial College Healthcare NHS Trust	London

Sponsors (8)

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

Countries where clinical trial is conducted

Germany,  Italy,  Lithuania,  Mexico,  Portugal,  United Kingdom, 

Outcome

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