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

NCT ID: NCT04453748

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-08

Study Completion Date

2021-11-30

Brief Summary

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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

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Conditions

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COVID-19 Coronavirus Infection Sars-CoV2 Complications

Keywords

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COVID-19 Sars-CoV2 Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 convalescents

People who recovered from COVID-19: have no symptoms and no SARS-Cov2 RNA in PCR

Complex diagnostic panel

Intervention Type OTHER

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

Interventions

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Complex diagnostic panel

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Agency, Poland

OTHER_GOV

Sponsor Role collaborator

Medical University of Silesia

OTHER

Sponsor Role collaborator

Silesian Centre for Heart Diseases

OTHER

Sponsor Role lead

Responsible Party

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Mariusz Gasior

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Silesian Centre for Heart Disease

Zabrze, Silesian Voivodeship, Poland

Site Status

Countries

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Poland

References

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Pudlo R, Jaworska I, Szczegielniak A, Niedziela J, Kulaczkowska Z, Nowowiejska-Wiewiora A, Jaroszewicz J, Gasior M. Prevalence of Insomnia in the Early Post-COVID-19 Recovery Period. Int J Environ Res Public Health. 2022 Oct 31;19(21):14224. doi: 10.3390/ijerph192114224.

Reference Type DERIVED
PMID: 36361102 (View on PubMed)

Other Identifiers

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COVID-19 Complications Study

Identifier Type: -

Identifier Source: org_study_id