Epidemiological Study of the COVID-2019 in Participating Organizations.

NCT05043142 | Completed Results

• 1 other identifier: EpidProtect-21
• Study Type: observational
• Target: 3,632
• Locations: 1 country
• Sites: 7

Brief Summary

Exhaustive, cross-sectional, non-interventional, multicenter retrospective epidemiological study, case study aimed to determine the relationship between the systematic use of prophylactics to prevent SARS, including COVID-2019, and the risks of incidence and serious complications of COVID-2019 among staff of participating organizations.

Conditions

Covid19

Keywords

Prevention; prophylactics; incidence; severity

Outcome Measures

Primary Outcomes (1)

• The Incidence of COVID-2019 Cases.

  The incidence of COVID-2019 cases in participating organizations by which study subjects are employed (SI National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky; Yuria-Pharm LLC; Infuzia PJSC; Institute Hyalual LLC; Medical Center M.T.K. LLC; InterChem SLC; Diatom LLC). .

  1 visit from March 2021 till June 2021

Secondary Outcomes (9)

• The Severity of the COVID-2019 Cases in Participating Organizations.

  1 visit from March 2021 till June 2021

• Prevention Methods of SARS, Including COVID-2019, Which Were Used by Subject That Had at Least One COVID-2019 Case.

  1 visit from March 2021 till June 2021

• Prevention Methods of SARS, Including COVID-2019, Which Were Used by Subject That Did Not Have Any COVID-2019 Case.

  1 visit from March 2021 till June 2021

• Relationship Between the Used Prevention Methods and and the Risk to Have at Least One Case of COVID-2019 Among Staff of Participating Organizations.

  1 visit from March 2021 till June 2021

• Relationship Between the Presence of Comorbidities, Such as Bronchial Asthma and COPD (Chronic Obstructive Pulmonary Disease), and the Risk to Have at Least One Case of COVID-2019.

  1 visit from March 2021 till June 2021

Interventions

ELISA test for the antibodies to COVID-2019. DIAGNOSTIC_TEST

Each subject will be assigned an individual number, which will be used for conduction of a rapid ELISA test for the antibodies to COVID-2019. Subjects will be notified of the test results.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons who are employed by one of the participating organizations (SI National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky; Yuria-Pharm LLC; Infuzia PJSC; Institute Hyalual LLC; Medical Center M.T.K. LLC; InterChem SLC; Diatom LLC).

You may qualify if:

• The subject gave the consent to participate in the study and signed the consent to processing of personal data.
• The subject aged 18 years and older.
• The subject is employed by one of the participating organizations.

Sponsors & Collaborators

• Yuria-Pharm: lead
• Pharmaxi LLC: collaborator

Study Sites (7)

SI National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky

Kyiv, 03038, Ukraine

Location

Institute Hyalual LLC

Kyiv, 03151, Ukraine

Location

Yuria-Pharm LLC

Kyiv, 03151, Ukraine

Location

Medical Center M.T.K. LLC

Kyiv, 03680, Ukraine

Location

Infuzia PJSC

Kyiv, 04073, Ukraine

Location

Diatom LLC

Kyiv, 04215, Ukraine

Location

InterChem SLC

Odesa, 65000, Ukraine

Location

Related Links

• Ann Bowling. Research Methods in Health: Investigating Health and Health Services, Fourth edition, 2014, Maidenhead, GB. McGraw Hill; Open University Press, 536pp
• Bernard Rosner. Fundamentals of Biostatistics, Seventh Edition, 2010.
• Ann Aschengrau. Essentials of Epidemiology in Public Health, Fourth Edition
• Bonita, Ruth, Beaglehole, Robert, Kjellström, Tord \& World Health Organization. (2006). Basic epidemiology, 2nd ed. World Health Organization
• Earl Babbie. The Practice of Social Research, Twelfth edition, 2009

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

* Probable selection bias (employed, but not present at office). * Long-term data collection there is a difference in the duration of action of the exposure factor. * The retrospective study design has limitations on the completeness and accuracy of the data provided by the study subjects. * The direction of the relationship cannot be determined for all relationships (there may be an inverse relationship).

Results Point of Contact

• Title: Tetiana Sprynsian
• Organization: Yuria-Pharm

Tetiana.Sprynsian.pm@pharmaxi.com.ua

+380665134849

Study Officials

• Tetiana Sprynsian

  Yuria-Pharm

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 14, 2021
• Study Start: March 16, 2021
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: October 1, 2021
• Results First Posted: October 1, 2021

Record last verified: 2021-09

Locations

UA (7)