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

• Conditions: Coronavirus Infection; Sars-CoV2; COVID-19; Complications
• Interventions: Other: Complex diagnostic panel

• Registration Number: NCT04453748
• Lead Sponsor: Silesian Centre for Heart Diseases

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-21
• Study Start: 2020-06-08
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30
• Primary Completion: 2021-10-31
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. SARS-Cov-2 RNA confirmed by the PCR method in the acute phase of disease.
2. Presence of the clinical symptoms associated with COVID-19 in the acute phase of disease
3. Two negative results of SARS-COV-2 PCR test following the 7-day period of quarantine
4. Informed consent

Exclusion Criteria

1. Any symptoms of infection during the quarantine
2. Lack of patient's consent
3. Lack of possibility of travelling to the hospital for tests

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 convalescents	Complex diagnostic panel	People who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR

Primary Outcome Measures

Name	Time	Method
Prevalence of COVID-19 complications	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 Outcome Measures

Name	Time	Method
Assessment of risk factors of COVID-19 complications	2 months	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

Trial Locations

Locations (1)

Silesian Centre for Heart Disease; 🇵🇱 Zabrze, Silesia, Poland