The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Silesian Centre for Heart Diseases
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Prevalence of COVID-19 complications
- Last Updated
- 5 years ago
Overview
Brief 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. 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
Investigators
Mariusz Gasior
Prof.
Silesian Centre for Heart Diseases
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Any symptoms of infection during the quarantine
- •Lack of patient's consent
- •Lack of possibility of travelling to the hospital for tests
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Assessment of risk factors of COVID-19 complications(2 months)