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.
Conditions: Covid19
Sponsor: Yuria-Pharm

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
1 
Project code 
EpidProtect-21 
Study 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.  
Version of Synopsis 
0.2, 15.02.2021. 
Justification of study 
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. 
Study design 
Exhaustive, cross-sectional, non-interventional, multicenter 
retrospective epidemiological study, case study.  
Number of subjects 
3443 subjects. 

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
2 
Location of study conduct 
Each subject will participate in the study in the participating 
organization by which the subject is 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.  
For the study the following facilities will be organized at each 
participating organization:  
 Specially designated locations for material collection and 
conduction of rapid ELISA tests for the antibodies to 
COVID-2019. 
 Specially 
designated 
computerized 
places 
for 
questionnaires with assigned staff who organize the 
order and accuracy of the questionnaire conduct.  
Duration of data collection 
3 months. 
Purpose of the study 
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.  
Study objectives 
 To investigate the incidence of COVID-2019 cases in 
participating organizations.  
 To investigate the severity of the COVID-2019 cases in 
participating organizations.  
 To explore the prevention methods used by staff members.  
 To determine the relationship between the used prevention 
methods and incidence of COVID-2019 among staff of 
participating organizations.  

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
3 
 To determine the relationship between the presence of 
comorbidities, such as bronchial asthma and COPD, and the 
incidence/severity of COVID-2019. 
 To determine the relationship between the COVID-2019 
case and the course of comorbidities, such as bronchial 
asthma and сhronic obstructive pulmonary disease (COPD). 
 To identify the 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. 
 To identify the 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. 
 To identify the 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.  
Methodology 
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.  

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
4 
For subjects who had the COVID-2019 case, a separate block of 
questionnaire was created to collect data on prophylactics, 
treatment of COVID-2019 case, 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 data entered 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. 
Duration of each subject's 
participation in the study 
1,5-2 hours. 
Visit schedule 
Visit 1. Conducting of a rapid ELISA test.  
Visit 2. Online questionnaires among staff of participating 
organizations. 
Study endpoints 
 The incidence of COVID-2019 cases in participating 
organizations. 
 The severity of the COVID-2019 cases in participating 
organizations. 
 Prevention methods of SARS, including COVID-2019, 
which were used by subject who had at least one COVID-
2019 case. 

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
5 
 Prevention methods of SARS, including COVID-2019, 
which were used by subject who did not have any COVID-
2019 case. 
 Relationship between the used prevention methods and 
incidence of COVID-2019 among staff of participating 
organizations.   
 Relationship between the presence of comorbidities, such as 
bronchial asthma and COPD, and the incidence/severity of 
COVID-2019 case. 
 Relationship between the COVID-2019 case and the course 
of comorbidities, such as bronchial asthma and сhronic 
obstructive pulmonary disease (COPD). 
 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 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 hospitalization of subjects who had at least 
one COVID-2019 case. 
Study variables 
 Demographic characteristics: age, gender. 
 Anthropometric characteristics: body weight, height. 
 Blood group. 
 Number of people in the household. 
 Lifestyle: the presence of bad habits, physical activity, diet. 
 Medical history: comorbidities, their treatment. 
 Prevention methods of SARS, including COVID-2019, 
currently used by the subject. 
 Number of COVID-2019 cases, which subject had. 
 Characteristics of the disease case, its treatment. 

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
6 
 Prevention methods of SARS, including COVID-2019, 
which were used by subject who had at least one COVID-
2019 case. 
 Prevention methods of SARS, including COVID-2019, 
which were used by subject who did not have any COVID-
2019 case. 
 Amount of costs spent on prevention and treatment of SARS, 
including COVID-2019.   
 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 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 hospitalization of subjects who had at least 
one COVID-2019 case. 
Inclusion criteria 
Subjects who meet all the inclusion criteria will be included in 
the study: 
 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/withdrawal criteria 
The nature of the study does not provide for withdrawal criteria.  
The subject may not be included in the study due to non-
compliance with the inclusion criteria or due to force majeure. 
Calculation of sample size  
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. 

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
7 
Study limitations 
Persons, who were employed by one of the participating 
organizations from March 1, 2020, but who do not have 
employment relations with the participating organizations 
during the study period or persons who are on maternity leave, 
will not be included in the study. 
Another study limitation is duration of data collection (due to 
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. 
There may be difficulties in filling in the missing data. 
Certain relationships can be difficult to describe.  
The direction of the relationship cannot be determined for all 
relationships (there may be an inverse relationship). 
Potential data distortion may be due to the subject selection; use 
of an electronic data collection system; possible low computer 
literacy of some subjects; lack of data verification and query 
generation.  
The completeness and correctness of the description of available 
medical documentation for fatal cases of COVID-2019 depends 
on the amount of information provided and its quality. 
Conclusions from it cannot be extended to other population 
members. 
 
 
 

Pharmaxi LLC 
EpidProtect-21, Synopsis  
Draft 0.2, 15.02.2021 
 
 
8 
Statistical analysis plan 
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.