Clinical trial NCT04453748: The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications
Official title: The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Coronavirus Infection
Sars-CoV2
Complications
Keywords: COVID-19
Sars-CoV2
Complications
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
Collaborators: name: Medical Research Agency, Poland
name: Medical University of Silesia
First posted: 2020-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who recovered from COVID-19 in Silesia, Poland.

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


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of COVID-19 complications
timeFrame: 2 months
Secondary outcomes:
measure: Assessment of risk factors of COVID-19 complications
timeFrame: 2 months
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Silesian Centre for Heart Disease
state: Silesia
Study officials:
References: