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Clinical Trials/NCT04453748
NCT04453748
Unknown
Not Applicable

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

Silesian Centre for Heart Diseases1 site in 1 country200 target enrollmentJune 8, 2020

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:

  1. the assessment of prevalence of particular complications after COVID-19.
  2. identification of the demographic and clinical risk factors of COVID-19 complications
  3. determining the diagnostic tests which are sufficient to detect early complications of COVID-19
Registry
clinicaltrials.gov
Start Date
June 8, 2020
End Date
November 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Silesian Centre for Heart Diseases
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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