Epidemiological Study of the COVID-2019 in Participating Organizations.

Covid19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05043142
• Other study ID #: EpidProtect-21
• Status: Completed
• Start date: March 16, 2021
• Est. completion date: June 23, 2021

Study information

• Verified date: September 2021
• Source: Yuria-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. The study aims to identify the incidence, characteristics of cases and their relationship with the preventive measures used. 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. The questionnaires will be conducted when the subject enters the data in the electronic case report form after signing the consent to processing of personal data. For the purposes of analysis, the subject enters his individual number in the questionnaire, as well as number of a rapid ELISA test for antibodies to COVID-2019 and its result. The entered data will be compared with the databases which contain the results of rapid ELISA tests. The questionnaire includes questions related to the main risks and protective factors of the COVID-2019 disease: demographic, anthropometric data, lifestyle data, prophylactics methods, subject's costs spent on COVID-2019 prophylactics. For subjects who had the COVID-2019 case, a separate block of questionnaire was created to collect data on prophylactics, treatment of COVID-2019, the course of the disease and the consequences of the disease case, as well as costs spent on COVID-2019 treatment. The completeness of entered data in the electronic case report form will be controlled by specially designated authorized persons in each participating organization, who were designated by the person responsible for conducting the study in each participating organization. The correctness of entered data in the electronic case report form will be controlled by remote monitoring. The questionnaire cannot be completed until all required fields of the case report form have been completed. A structured description of the available medical documentation for fatal cases of COVID-2019 will be conducted separately. Demographic, anthropometric data, lifestyle data, prophylactics methods, treatment of COVID-2019, the course of the COVID-2019 case will be described. Calculation of sample size is not applicable as it is exhaustive study. Participating organizations undertake to organize the involvement in the study of at least 95% of persons employed by participating organizations. In the context of this data analysis, all the main steps from the primary data to the results of the study will be described separately in the Statistical Analysis Plan. This study is not intended to accept or reject pre-defined hypotheses, thus statistical analysis will mainly be descriptive. All types of analysis will be done for the entire available study population with available data. If there is a sufficient amount of data in the subpopulations, a separate statistical analysis will be performed. No conditional calculation methods will be applied to the missed values. The statistical generalization will consist of frequency tables of categorical variables (number, %). For metric variables, descriptive statistics (number of subjects with available observations, number of missed values, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum) will be presented in tabular form. Statistical conclusions will be used to assess the potential relationship between the identified variables and the incidence / severity of COVID-2019. The relationship between the subject's characteristics and the variables of interest will be assessed using a one-dimensional and multidimensional (polynomial) logistic regression model for variables, which have no more than 20% omitted data. The final model will be selected with a view to minimizing the Akaike information criterion value. 2×2 tables, χ-square were used for calculations of odds ratios. Rough odds ratios and adjusted odds ratios with corresponding 95% confidence intervals and p-values will be generated and presented for both one-dimensional and multidimensional logistics models.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3632
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject gave the consent to participate in the study and signed the consent to processing of personal data.

2. The subject aged 18 years and older.

3. 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• ELISA test for the antibodies to COVID-2019.
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.

Locations

Country	Name	City	State
Ukraine	Diatom LLC	Kyiv
Ukraine	Infuzia PJSC	Kyiv
Ukraine	Institute Hyalual LLC	Kyiv
Ukraine	Medical Center M.T.K. LLC	Kyiv
Ukraine	SI National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky	Kyiv
Ukraine	Yuria-Pharm LLC	Kyiv
Ukraine	InterChem SLC	Odessa

Sponsors (2)

Lead Sponsor	Collaborator
Yuria-Pharm	Pharmaxi LLC

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Severity of the COVID-2019 Cases in Participating Organizations.	The severity of the 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	Prevention Methods of SARS, Including COVID-2019, Which Were Used by Subject That Had at Least One COVID-2019 Case.	Prevention methods of SARS, including COVID-2019, which were used by subject that had at least one COVID-2019 case. The number of participants is reported for every prevention method separately.	1 visit from March 2021 till June 2021
Secondary	Prevention Methods of SARS, Including COVID-2019, Which Were Used by Subject That Did Not Have Any COVID-2019 Case.	Prevention methods of SARS, including COVID-2019, which were used by subject that did not have any COVID-2019 case. The number of participants is reported for every prevention method separately.	1 visit from March 2021 till June 2021
Secondary	Relationship Between the Used Prevention Methods and and the Risk to Have at Least One Case of COVID-2019 Among Staff of Participating Organizations.	Relationship between the used prevention methods and iand the Risk to Have at Least One Case of COVID-2019. among staff of participating organizations.Prevention methods within this outcome includes all prevention methods which were used by subjects. Measure of outcome is risk ratio (RR), also called relative risk, compares the risk of a health event (disease, injury, risk factor, or death) among one group with the risk among another group. It does so by dividing the risk (incidence proportion, attack rate) in group 1 by the risk (incidence proportion, attack rate) in group 2. If the risk ratio is 1 (or close to 1), it suggests no difference or little difference in risk (incidence in each group is the same). A risk ratio > 1 suggests an increased risk of that outcome in the exposed group. A risk ratio < 1 suggests a reduced risk in the exposed group.	1 visit from March 2021 till June 2021
Secondary	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.	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. Measure of outcome is risk ratio (RR), also called relative risk, compares the risk of a health event (disease, injury, risk factor, or death) among one group with the risk among another group. It does so by dividing the risk (incidence proportion, attack rate) in group 1 by the risk (incidence proportion, attack rate) in group 2. If the risk ratio is 1 (or close to 1), it suggests no difference or little difference in risk (incidence in each group is the same). A risk ratio > 1 suggests an increased risk of that outcome in the exposed group. A risk ratio < 1 suggests a reduced risk in the exposed group.	1 visit from March 2021 till June 2021
Secondary	Relationship Between the COVID-2019 Case and the Risk of Change of the Course of Comorbidities, Such as Bronchial Asthma and ?hronic Obstructive Pulmonary Disease (COPD).	Relationship between the COVID-2019 case and the risk of change of the course of comorbidities, such as bronchial asthma and ?hronic obstructive pulmonary disease (COPD). Measure of outcome is risk ratio (RR), also called relative risk, compares the risk of a health event (disease, injury, risk factor, or death) among one group with the risk among another group. It does so by dividing the risk (incidence proportion, attack rate) in group 1 by the risk (incidence proportion, attack rate) in group 2. If the risk ratio is 1 (or close to 1), it suggests no difference or little difference in risk (incidence in each group is the same). A risk ratio > 1 suggests an increased risk of that outcome in the exposed group. A risk ratio < 1 suggests a reduced risk in the exposed group.	1 visit from March 2021 till June 2021
Secondary	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.	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. Measure of outcome is risk ratio (RR), also called relative risk, compares the risk of a health event (disease, injury, risk factor, or death) among one group with the risk among another group. It does so by dividing the risk (incidence proportion, attack rate) in group 1 by the risk (incidence proportion, attack rate) in group 2. If the risk ratio is 1 (or close to 1), it suggests no difference or little difference in risk (incidence in each group is the same). A risk ratio > 1 suggests an increased risk of that outcome in the exposed group. A risk ratio < 1 suggests a reduced risk in the exposed group.	1 visit from March 2021 till June 2021
Secondary	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.	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. Measure of outcome is risk ratio (RR), also called relative risk, compares the risk of a health event (disease, injury, risk factor, or death) among one group with the risk among another group. It does so by dividing the risk (incidence proportion, attack rate) in group 1 by the risk (incidence proportion, attack rate) in group 2. If the risk ratio is 1 (or close to 1), it suggests no difference or little difference in risk (incidence in each group is the same). A risk ratio > 1 suggests an increased risk of that outcome in the exposed group. A risk ratio < 1 suggests a reduced risk in the exposed group.	1 visit from March 2021 till June 2021
Secondary	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.	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. Measure of outcome is risk ratio (RR), also called relative risk, compares the risk of a health event (disease, injury, risk factor, or death) among one group with the risk among another group. It does so by dividing the risk (incidence proportion, attack rate) in group 1 by the risk (incidence proportion, attack rate) in group 2. If the risk ratio is 1 (or close to 1), it suggests no difference or little difference in risk (incidence in each group is the same). A risk ratio > 1 suggests an increased risk of that outcome in the exposed group. A risk ratio < 1 suggests a reduced risk in the exposed group.	1 visit from March 2021 till June 2021

External Links

•   Ann Aschengrau. Essentials of Epidemiology in Public Health, Fourth Edition
•   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.
•   Bohdan O. What do you need to know about sociology and social research? Handbook for social activists and all concerned / Olena Bohdan; consultant-reviewer Volodymyr Paniotto. - ?.: Dukh i Litera, 2015. - 380 p.
•   Bonita, Ruth, Beaglehole, Robert, Kjellstro¨m, Tord & World Health Organization. (2006). Basic epidemiology, 2nd ed. World Health Organization
•   Earl Babbie. The Practice of Social Research, Twelfth edition, 2009