The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications

Study Overview
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Brief Summary
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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

Official Title
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The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications

Conditions
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COVID-19, Coronavirus Infection, Sars-CoV2, Complications

Intervention / Treatment
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* Other: Complex diagnostic panel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 convalescents<br>People who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR | Other: Complex diagnostic panel<br>* Complex, multidisciplinary diagnostic panel, including blood, imaging and functional tests.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complications, COVID-19, Sars-CoV2