Official Title
Characteristics and Predictors of Early and Late Cardiovascular Complications of Covid-19 Patients - the PoLoCOV-Study (Polish LONG-COVID Cardiovascular Study)
Brief Summary

Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results frominfection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 isnot only a short-term infection. Patients (pts) recovering from SARS-COV2 infectioncomplain of persisting symptoms including: fatigue, diffuse myalgia and weakness, whichmay lead to chronic fatigue syndrome and as well as many other complications.The vast majority of COVID-19 patients remaining in isolation/quarantine, due to the mildcourse of the disease, do not require hospitalization. In this group of patients, thecourse of COVID-19 is very different - from asymptomatic patients to very severe and longlasting symptoms also with a decrease in saturation.There are many studies describing the course and complications of patients hospitalizeddue to COVID-19. There is little published data on how non-hospitalized patients get sickand what are the early and late complications of SARS-CoV-2 infection. In addition, manypatients remain ill even many months after COVID-19, entering what is known asLONG-COVID.Therefore, the STOP-COVID Registry was established. The purpose of the Registry is toassess the course of COVID-19 infection, early and late cardiovascular complications ofCOVID-19 in patients with and without hospitalization. In addition, the purpose of theSTOP-COVID Registry is to assess the incidence of LONG-COVID with all other complicationsand to identify predictive factors.

Detailed Description

The following patients are included in the Registry: Patients 18 years and older
diagnosed with COVID-19, in accordance with the current guidelines of the Ministry of
Health of Poland, after full recovery (resolution of clinical symptoms, minimum 14 days
after last symptoms). The Registry includes patients with and without hospitalization .

Approval from the Bioethics Committee of Lodz Regional Medical Chamber to conduct the
Registry was obtained.

The Registry was held at the: Saint Family Hospital Medical Center, Lodz, Poland Patient
information, course of the disease, post-COVID-19 complaints, comorbidities and current
treatment were collected at visit "0" within 4-8 weeks after the end of COVID-19.

Subsequently, patients were ordered the following tests:

- 12-lead ECG

- 24-hour Holter ECG monitoring

- 24-hour Holter blood pressure monitoring

- Echocardiographic of the Heart assessment

- Biochemical tests: Lipid Profile (total cholesterol, LDL fraction, HDL,
triglycerides), glucose or glycosylated hemoglobin (HbA1c) level, D-dimers.

In patients with indications, the following were additionally performed: MRI of the
heart, Angio CT of pulmonary vessels, Angio CT of coronary vessels or other diagnostic
tests. Depending on the indications of the pts, they were referred for other tests and
specialist consultations. All pts were diagnosed and treated in accordance with the
current recommendations of the European Cardiology Society (ESC) and Polish Cardiac
Society (PCS).

If any abnormalities were found, patients were treated in accordance with the current ESC
guidelines. In the event of complications after COVID-19, each patient will be treated in
accordance with current guidelines and recommendations, in accordance with current
medical knowledge.

After a period of 3 months after COVID-19, new symptoms that appeared after COVID-19,
remained and/or worsened after COVID-19 were assessed at the follow-up visit, based on
the patient's interview. If such symptoms occurred, patients were classified as
LONG-COVID. Symptoms that may have resulted from the severity of the underlying condition
were not classified as LONG-COVID.

Patients with LONG-COVID, after excluding complications/contraindications, will be
referred to the post-COVID rehabilitation program. This program covers a comprehensive
range of rehabilitation with dietary and psychological consultations. Patients referred
to the rehabilitation program will constitute the REHA-STOP-COVID group. The
rehabilitation program will last 6 weeks. At the beginning and at the end of the program,
each patient will have fitness assessment performed with the following tests:

- oxygen saturation assessment performed with a pulse oximeter;

- physical capacity assessment with 6 minute walking test (6MWT)

- Dyspnea assessment with modified 0-10 Borg scale

- Fatigue assessment with Modified Fatigue Impact Scale (MFIS)

- Muscle Strength Assessment

- lower extremity function and mobility with Short Physical Performance Battery test
(SPPB)

Annual reassessment of all patients is planned for 5 years after COVID-19.

During the control visits, patients will be ordered the following:

- Clinical evaluation with health assessment, comorbidities and symptoms that may be
due to a history of COVID-19

- 12-lead ECG

- 24-hour Holter ECG monitoring

- 24-hour Holter blood pressure monitoring

- Echocardiographic of the Heart assessment

- Biochemical tests: Lipid Profile (total cholesterol, LDL fraction, HDL,
triglycerides), glucose or glycosylated hemoglobin (HbA1c).

Additionally, a questionnaire will be completed by the patient with an assessment of
his/her health, weight, height, BMI, risk factors for cardiovascular diseases (smoking,
alcohol abuse), physical activity, all medications that the patient takes, whether the
patient was re-infected with SARS-CoV in the past years (date) , whether the patient was
vaccinated (with full vaccination date).

Each patient from the STOP-COVID program, in the event of deterioration of health and /
or the appearance of new ailments, may be referred for the consultation to the Saint
Family Hospital Medical Center by a GP and/or another specialist during the whole period
of the study.

During the entire study period, the following will be registered in the medical database:

1. Any new medical event assessed by 2 doctors as a complication after COVID-19

2. Any hospitalization related to complications of COVID-19 as well as any other reason

3. Each severity has already been diseases diagnosed and treated, with information
whether it required correction / modification of the current treatment

4. Any newly diagnosed diseases

5. Any abnormalities in the results of diagnostic examinations, laboratory tests and
consultations

Unknown status
COVID19
LONG-COVID
Eligibility Criteria

Inclusion Criteria:

Patients after COVID-19, 18 years and older

Exclusion Criteria:

None

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Poland
Locations

Medical Center, Saint Family Hospital
Łódź, Poland

Michal Chudzik
NCT Number
Keywords
COVID19
Covid complications
Long-COVID
Chronic Fatigue Syndrome
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome