Exhaustive, Cross-sectional, Non-interventional, Multicenter Retrospective Epidemiological Study of the COVID-2019 Incidence and Prevention Methods of SARS, Including COVID-2019, Among Staff of Participating Organizations.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,632
- Locations
- 7
- Primary Endpoint
- The Incidence of COVID-2019 Cases.
Study Overview
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.
Detailed Description
Coronaviruses are a large family of viruses that might cause illness in animals or humans. SARS-CoV-2 is an enveloped, single-stranded RNA virus of the β genus. It can cause respiratory illness named COVID-19, the severity of which varies from asymptomatic to severe, and which can lead to the patient's death of the long-term consequences (so-called post-COVID syndrome). The virus has spread globally and been declared a Public Health Emergency of International Concern by WHO in January 30, 2020.
The first case of COVID-19 in Ukraine was detected in early March, 2020. 1273475 cases of the disease have been registered in Ukraine as at February 15, 2021.
Quarantine restrictions and other anti-epidemic measures established in Ukraine and their results are the subject of wide debate.
Own anti-epidemic measures, in addition to those established by the Government, have also been implemented by numerous representatives of the public sector, non-governmental organizations and business.
The company management of the participating organizations decided to provide their staff with prophylactic tools and recommendations for COVID-19 prevention.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •The subject may not be included in the study due to non-compliance with the inclusion criteria or due to force majeure.
Outcomes
Primary Outcomes
The Incidence of COVID-2019 Cases.
Time Frame: 1 visit from March 2021 till June 2021
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). .
Secondary Outcomes
- 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)
- 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 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)
- Relationship Between Different Strategies and Combinations of Drugs Used for Prophylactics at Any Time From March 2020 and the Risk of Having a Severe COVID-2019 Case.(1 visit from March 2021 till June 2021)
- Relationship Between the COVID-2019 Case and the Risk of Change of the Course of Comorbidities, Such as Bronchial Asthma and сhronic Obstructive Pulmonary Disease (COPD).(1 visit from March 2021 till June 2021)
- Relationship Between Different Strategies and Combinations of Drugs Used for Prophylactics at Any Time From March 2020 and the Risk of Having a COVID-2019 Case.(1 visit from March 2021 till June 2021)
- Relationship Between Different Strategies and Combinations of Drugs Used for Prophylactics at Any Time From March 2020 and the Risk of Hospitalization of Persons Who Had at Least One COVID-2019 Case.(1 visit from March 2021 till June 2021)