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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04453748
• Other study ID #: COVID-19 Complications Study
• Status: Enrolling by invitation
• Start date: June 8, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: September 2020
• Source: Silesian Centre for Heart Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: November 30, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Sars-CoV2
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Complex diagnostic panel
Complex, multidisciplinary diagnostic panel, including blood, imaging and functional tests.

Locations

Country	Name	City	State
Poland	Silesian Centre for Heart Disease	Zabrze	Silesia

Sponsors (3)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases	Medical Research Agency - Agencja Badan Medycznych, Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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