COVID-19NCT04453748
The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications
An observational study of COVID-19 and Coronavirus Infection, run by Silesian Centre for Heart Diseases at 1 site in Poland.
Trial summary
SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory and lung involvement may include the cardiovascular system, the nervous system and the liver. In the acute phase of the disease, all of these conditions may be life-threatened. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COVID-19, Coronavirus Infection, Sars-CoV2
- What is being tested?
- Complex diagnostic panel
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 8 Jun 2020to 30 Nov 2021
- How long will I take part?
- 2 Months
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who recovered from COVID-19 in Silesia, Poland.
Who may be able to join
- SARS-Cov-2 RNA confirmed by the PCR method in the acute phase of disease.
- Presence of the clinical symptoms associated with COVID-19 in the acute phase of disease
- Two negative results of SARS-COV-2 PCR test following the 7-day period of quarantine
- Informed consent
Who cannot join
- Any symptoms of infection during the quarantine
- Lack of patient's consent
- Lack of possibility of travelling to the hospital for tests
Trial locations and contacts
1 site in 1 country.
Poland1 site
Silesian Centre for Heart Disease
Zabrze, Silesian Voivodeship, 41-800
About this study
SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory and lung involvement may include the cardiovascular system, the nervous system and the liver. In the acute phase of the disease, all of these conditions may be life-threatened. As a result, after the acute phase of COVID-19, early complications may be observed, including heart, lungs, brain, muscles and liver. A few papers to date have been reported of myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse prognostic effects. Due to the extent of the pandemic, the severity of the complications and the expected high complications' prevalence in the early post-recovery period, a study was designed to determine the extent of the problem of early complications after COVID-19. Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned, including laboratory, imaging and functional tests. The results obtained, in addition to determining the scale of the problem, will allow the selection of studies that optimally identify patients with early complications. The purpose of this procedure is to enable rapid treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect raised in the project will be the issue of psychiatric disorders (anxiety, depression, post traumatic disorders).
The main three purposes of the study include:
- the assessment of prevalence of particular complications after COVID-19.
- identification of the demographic and clinical risk factors of COVID-19 complications
- determining the diagnostic tests which are sufficient to detect early complications of COVID-19
- Conditions
- COVID-19, Coronavirus Infection, Sars-CoV2, Complications
- Being tested
- Complex diagnostic panel
- Keywords
- COVID-19, Sars-CoV2, Complications
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex diagnostic panelOther
Complex, multidisciplinary diagnostic panel, including blood, imaging and functional tests.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 convalescents | People who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR Receives: Other: Complex diagnostic panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of COVID-19 complications
Complications include pulmonary, cardio-vascular, neurological, hepatologic and psychiatric disordes that might be linked to the COVID-19.
The diagnostic tests: blood tests, transthoracic echocardiography, spirometry, high-resolution computed tomography, neurological examination, liver ultrasonography and elastography, vasular ultrasonography (veins and arteries), psychiatric questionnairies
Measured: 2 months
Secondary outcomes (1)
Assessment of risk factors of COVID-19 complications
Analysis which demographic and clinical parametrs were associated with particular COVID-19 complication.
Statistical analysis of relation between clinical parameters before and during COVID19 and the occurence of COVID19 complications
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start8 Jun 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland, Medical University of Silesia
- Responsible party
- Principal investigator, Mariusz Gasior, Silesian Centre for Heart Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453748
- Sponsor's protocol ID
- COVID-19 Complications Study
- Status last verified
- Sep 2020
- First submitted
- 21 May 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pudlo R, Jaworska I, Szczegielniak A, Niedziela J, Kulaczkowska Z, Nowowiejska-Wiewiora A, Jaroszewicz J, Gasior M. Prevalence of Insomnia in the Early Post-COVID-19 Recovery Period. Int J Environ Res Public Health. 2022 Oct 31;19(21):14224. doi: 10.3390/ijerph192114224.
PubMed 36361102
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications
- ClinicalTrials.gov ID
- NCT04453748
- Acronym / sponsor ID
- COVID-19 Complications Study
- Conditions
- COVID-19, Coronavirus Infection, Sars-CoV2, Complications
- Keywords
- COVID-19, Sars-CoV2, Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland, Medical University of Silesia
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 1 Jul 2020 (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.
SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory and lung involvement may include the cardiovascular system, the nervous system and the liver. In the acute phase of the disease, all of these conditions may be life-threatened. As a result, after the acute phase of COVID-19, early complications may be observed, including heart, lungs, brain, muscles and liver. A few papers to date have been reported of myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse prognostic effects. Due to the extent of the pandemic, the severity of the complications and the expected high complications' prevalence in the early post-recovery period, a study was designed to determine the extent of the problem of early complications after COVID-19. Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned, including laboratory, imaging and functional tests. The results obtained, in addition to determining the scale of the problem, will allow the selection of studies that optimally identify patients with early complications. The purpose of this procedure is to enable rapid treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect raised in the project will be the issue of psychiatric disorders (anxiety, depression, post traumatic disorders).
The main three purposes of the study include:
- the assessment of prevalence of particular complications after COVID-19.
- identification of the demographic and clinical risk factors of COVID-19 complications
- determining the diagnostic tests which are sufficient to detect early complications of COVID-19
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 convalescents | – | Other: Complex diagnostic panelPeople who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who recovered from COVID-19 in Silesia, Poland.
Key inclusion criteria (4 listed)
- SARS-Cov-2 RNA confirmed by the PCR method in the acute phase of disease.
- Presence of the clinical symptoms associated with COVID-19 in the acute phase of disease
- Two negative results of SARS-COV-2 PCR test following the 7-day period of quarantine
- Informed consent
Key exclusion criteria (3 listed)
- Any symptoms of infection during the quarantine
- Lack of patient's consent
- Lack of possibility of travelling to the hospital for tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex diagnostic panelComplex, multidisciplinary diagnostic panel, including blood, imaging and functional tests. | Other | COVID-19 convalescents |
Primary outcome
Prevalence of COVID-19 complications
Time frame: 2 months
Complications include pulmonary, cardio-vascular, neurological, hepatologic and psychiatric disordes that might be linked to the COVID-19. The diagnostic tests: blood tests, transthoracic echocardiography, spirometry, high-resolution computed tomography, neurological examination, liver ultrasonography and elastography, vasular ultrasonography (veins and arteries), psychiatric questionnairies
1 secondary outcome
Assessment of risk factors of COVID-19 complications
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 36361102Pudlo R, Jaworska I, Szczegielniak A, Niedziela J, Kulaczkowska Z, Nowowiejska-Wiewiora A, Jaroszewicz J, Gasior M. Prevalence of Insomnia in the Early Post-COVID-19 Recovery Period. Int J Environ Res Public Health. 2022 Oct 31;19(21):14224. doi: 10.3390/ijerph192114224.
- Individual participant dataSharing planned: Undecided
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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 COVID-19 and Coronavirus Infection, run by Silesian Centre for Heart Diseases 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 4 inclusion and 3 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 30 Sep 2020. 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?
Prevalence of COVID-19 complications (time frame: 2 months). 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 NCT04453748, which also lists 1 linked publication.
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 30 Sep 2020.