Covid19NCT05018052
Early and Late Complications of COVID-19
An observational study of Covid19 and LONG-COVID, run by Michal Chudzik at 1 site in Poland.
Trial summary
Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, LONG-COVID
- How many people
- 1,900 participants
- Where
- 1 sitePoland
- Study dates
- 29 May 2020to 30 Sep 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older diagnosed with COVID-19, after full recovery (resolution of clinical symptoms, minimum 14 days after last symptoms), with and without hospitalization .
Who may be able to join
- Patients after COVID-19, 18 years and older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Predictors of Early and Late Cardiovascular Complications of Covid-19 Patients - the PoLoCOV-Study (Polish LONG-COVID Cardiovascular Study)
Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection. Patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may 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 mild course of the disease, do not require hospitalization. In this group of patients, the course of COVID-19 is very different - from asymptomatic patients to very severe and long lasting symptoms also with a decrease in saturation.
Read more
There are many studies describing the course and complications of patients hospitalized due to COVID-19. There is little published data on how non-hospitalized patients get sick and what are the early and late complications of SARS-CoV-2 infection. In addition, many patients remain ill even many months after COVID-19, entering what is known as LONG-COVID.
Therefore, the STOP-COVID Registry was established. The purpose of the Registry is to assess the course of COVID-19 infection, early and late cardiovascular complications of COVID-19 in patients with and without hospitalization. In addition, the purpose of the STOP-COVID Registry is to assess the incidence of LONG-COVID with all other complications and to identify predictive factors.
Read the 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:
- Any new medical event assessed by 2 doctors as a complication after COVID-19
- Any hospitalization related to complications of COVID-19 as well as any other reason
- Each severity has already been diseases diagnosed and treated, with information whether it required correction / modification of the current treatment
- Any newly diagnosed diseases
- Any abnormalities in the results of diagnostic examinations, laboratory tests and consultations
- Conditions
- Covid19, LONG-COVID
- Keywords
- Covid19, Covid complications, Long-Covid, Chronic Fatigue Syndrome
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Early and Late COVID-19 cardio-vascular complications
Early and Late COVID-19 cardio-vascular complications
Measured: 5 years
Predictors of Long-Covid Cardio-Vascular complications
Predictors of Long-Covid Cardio-Vascular complications
Measured: 5 years
SCORE - algorithm to help to predict the highest risk of Long-Covid complications
SCORE - algorithm to help to predict the highest risk of Long-Covid complications
Measured: 5 years
Secondary outcomes (3)
Detailed patients' characteristics and differences in those with and without Long-Covid complications
Detailed patients' characteristics and differences in those with and without Long-Covid
Measured: 5 years
Definition and characteristics of the early and Late COVID-19 complications
Definition and characteristics of the early and Late COVID-19 complications
Measured: 5 years
Comparison of complications and Long-Covid depending on the severity of the course of COVID-19 COVID-19, comorbidities
Comparison of complications and Long-Covid depending on the severity of the course of COVID
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start29 May 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 1,900 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Michal Chudzik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michal Chudzik, Saint Family Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018052
- Sponsor's protocol ID
- Stop-Covid/1/2021
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babicki M, Kapusta J, Kolat D, Kaluzinska-Kolat Z, Mastalerz-Migas A, Jankowski P, Chudzik M. Cardiac symptoms in patients 3-6 months after contracting COVID-19- data from the polish STOP-COVID registry. BMC Infect Dis. 2025 Apr 9;25(1):489. doi: 10.1186/s12879-025-10774-0.
PubMed 40205590Kapusta J, Chudzik M, Kaluzinska-Kolat Z, Kolat D, Burzynska M, Jankowski P, Babicki M. Do selected lifestyle parameters affect the severity and symptoms of COVID-19 among elderly patients? The retrospective evaluation of individuals from the STOP-COVID registry of the PoLoCOV study. J Infect Public Health. 2023 Jan;16(1):143-153. doi: 10.1016/j.jiph.2022.12.008. Epub 2022 Dec 12.
PubMed 36521330
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Predictors of Early and Late Cardiovascular Complications of Covid-19 Patients - the PoLoCOV-Study (Polish LONG-COVID Cardiovascular Study)
- ClinicalTrials.gov ID
- NCT05018052
- Acronym / sponsor ID
- Stop-Covid/1/2021
- Conditions
- Covid19, LONG-COVID
- Keywords
- Covid19, Covid complications, Long-Covid, Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Michal ChudzikUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 24 Aug 2021 (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.
Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection. Patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may 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 mild course of the disease, do not require hospitalization. In this group of patients, the course of COVID-19 is very different - from asymptomatic patients to very severe and long lasting symptoms also with a decrease in saturation.
There are many studies describing the course and complications of patients hospitalized due to COVID-19. There is little published data on how non-hospitalized patients get sick and what are the early and late complications of SARS-CoV-2 infection. In addition, many patients remain ill even many months after COVID-19, entering what is known as LONG-COVID.
Therefore, the STOP-COVID Registry was established. The purpose of the Registry is to assess the course of COVID-19 infection, early and late cardiovascular complications of COVID-19 in patients with and without hospitalization. In addition, the purpose of the STOP-COVID Registry is to assess the incidence of LONG-COVID with all other complications and 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:
- Any new medical event assessed by 2 doctors as a complication after COVID-19
- Any hospitalization related to complications of COVID-19 as well as any other reason
- Each severity has already been diseases diagnosed and treated, with information whether it required correction / modification of the current treatment
- Any newly diagnosed diseases
- Any abnormalities in the results of diagnostic examinations, laboratory tests and consultations
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years and older diagnosed with COVID-19, after full recovery (resolution of clinical symptoms, minimum 14 days after last symptoms), with and without hospitalization .
Key inclusion criteria (1 listed)
- Patients after COVID-19, 18 years and older
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early and Late COVID-19 cardio-vascular complications
Time frame: 5 years
Early and Late COVID-19 cardio-vascular complications
Predictors of Long-Covid Cardio-Vascular complications
Time frame: 5 years
Predictors of Long-Covid Cardio-Vascular complications
SCORE - algorithm to help to predict the highest risk of Long-Covid complications
Time frame: 5 years
SCORE - algorithm to help to predict the highest risk of Long-Covid complications
3 secondary outcomes
Detailed patients' characteristics and differences in those with and without Long-Covid complications
Time frame: 5 years
Definition and characteristics of the early and Late COVID-19 complications
Time frame: 5 years
Comparison of complications and Long-Covid depending on the severity of the course of COVID-19 COVID-19, comorbidities
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 40205590Babicki M, Kapusta J, Kolat D, Kaluzinska-Kolat Z, Mastalerz-Migas A, Jankowski P, Chudzik M. Cardiac symptoms in patients 3-6 months after contracting COVID-19- data from the polish STOP-COVID registry. BMC Infect Dis. 2025 Apr 9;25(1):489. doi: 10.1186/s12879-025-10774-0.
- Derived from this study: PubMed 36521330Kapusta J, Chudzik M, Kaluzinska-Kolat Z, Kolat D, Burzynska M, Jankowski P, Babicki M. Do selected lifestyle parameters affect the severity and symptoms of COVID-19 among elderly patients? The retrospective evaluation of individuals from the STOP-COVID registry of the PoLoCOV study. J Infect Public Health. 2023 Jan;16(1):143-153. doi: 10.1016/j.jiph.2022.12.008. Epub 2022 Dec 12.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and LONG-COVID, run by Michal Chudzik at 1 site in Poland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early and Late COVID-19 cardio-vascular complications (time frame: 5 years). The study lists 3 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 NCT05018052, which also lists 2 linked publications.
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 24 Aug 2021.