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

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

Study Overview

• Status: Unknown
• Conditions: COVID-19; Coronavirus Infection; Complications; Sars-CoV2
• Intervention / Treatment: Other: Complex diagnostic panel

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Poland
  • Silesia
    • Zabrze, Silesia, Poland, 41-800
      • Silesian Centre for Heart Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who recovered from COVID-19 in Silesia, Poland.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 convalescents; People who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR	Other: Complex diagnostic panel; Complex, multidisciplinary diagnostic panel, including blood, imaging and functional tests.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Silesian Centre for Heart Diseases
• Collaborators: Medical University of Silesia; Medical Research Agency, Poland

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2020
• Primary Completion (ANTICIPATED): October 31, 2021
• Study Completion (ANTICIPATED): November 30, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Complications; Sars-CoV2
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: COVID-19 Complications Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No