NCT04627623

Brief Summary

Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at:

  1. 1.analysis of available data on incidence and mortality due to COVID-19 and
  2. 2.estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors.

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
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 22, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2021

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

November 12, 2020

Last Update Submit

November 13, 2020

Conditions

Covid19Respiratory Tract InfectionsSevere Acute Respiratory SyndromeCorona Virus InfectionRNA Virus InfectionsVirus DiseaseRespiratory Tract Disease

Keywords

Covid19Risk factorsPrevalenceMortalityanti-SARS-CoV-2 antibodies

Outcome Measures

Primary Outcomes (1)

  • Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population.

    Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population.

    8 months

Secondary Outcomes (1)

  • Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies

    8 months

Study Arms (1)

Screened arm

6000 peoples (3x2000) in all ages randomly selected from the general population of three towns (Katowice, Sosnowiec, Gliwice). From all invited is collected a venous blood samples (5ml) to assay IgM and IgG antibodies.

Diagnostic Test: IgM and IgG antibodies assay

Interventions

IgM and IgG antibodies assayDIAGNOSTIC_TEST

5 ml venous blood sample collection to assay IgM and IgM against COVID19

Screened arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Selected by random inhabitants of one of three towns (Katowice, Sosnowiec, Gliwice) with no age limits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnostyka sp zoo

Katowice, 40-282, Poland

RECRUITING

Related Publications (4)

  • Pan Y, Li X, Yang G, Fan J, Tang Y, Zhao J, Long X, Guo S, Zhao Z, Liu Y, Hu H, Xue H, Li Y. Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients. J Infect. 2020 Jul;81(1):e28-e32. doi: 10.1016/j.jinf.2020.03.051. Epub 2020 Apr 10.

    PMID: 32283141BACKGROUND

  • Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, Sun R, Wang Y, Hu B, Chen W, Zhang Y, Wang J, Huang B, Lin Y, Yang J, Cai W, Wang X, Cheng J, Chen Z, Sun K, Pan W, Zhan Z, Chen L, Ye F. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Sep;92(9):1518-1524. doi: 10.1002/jmv.25727. Epub 2020 Apr 13.

    PMID: 32104917BACKGROUND

  • Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.

    PMID: 32221519BACKGROUND

  • Lee CY, Lin RTP, Renia L, Ng LFP. Serological Approaches for COVID-19: Epidemiologic Perspective on Surveillance and Control. Front Immunol. 2020 Apr 24;11:879. doi: 10.3389/fimmu.2020.00879. eCollection 2020.

    PMID: 32391022BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

5 ml venous blood sample

MeSH Terms

Conditions

COVID-19Respiratory Tract InfectionsSevere Acute Respiratory SyndromeCoronavirus InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsCoronaviridae InfectionsNidovirales InfectionsLung Diseases

Study Officials

  • Jan E Zejda, Prof

    Medical University of Silesia in Katowice Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grzegorz M Brozek, Prof

CONTACT

0048 693 700 184gbrozek@sum.edu.pl

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Grzegorz Brożek, MD PhD

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 13, 2020

Study Start

June 22, 2020

Primary Completion

March 22, 2021

Study Completion

April 22, 2021

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)