NCT04453748

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. 1.the assessment of prevalence of particular complications after COVID-19.
  2. 2.identification of the demographic and clinical risk factors of COVID-19 complications
  3. 3.determining the diagnostic tests which are sufficient to detect early complications of COVID-19

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

May 21, 2020

Last Update Submit

September 28, 2020

Conditions

COVID-19Coronavirus InfectionSars-CoV2Complications

Keywords

COVID-19Sars-CoV2Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of risk factors of COVID-19 complications

    2 months

Study Arms (1)

COVID-19 convalescents

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

Other: Complex diagnostic panel

Interventions

Complex diagnostic panelOTHER

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

COVID-19 convalescents

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Any symptoms of infection during the quarantine
  • Lack of patient's consent
  • Lack of possibility of travelling to the hospital for tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silesian Centre for Heart Disease

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Related Publications (1)

  • 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.

    PMID: 36361102DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 21, 2020

First Posted

July 1, 2020

Study Start

June 8, 2020

Primary Completion

October 31, 2021

Study Completion

November 30, 2021

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

PL(1)