Covid19NCT05043142
Epidemiological Study of the COVID-2019 in Participating Organizations.
An observational study of Covid19, run by Yuria-Pharm at 7 sites in Ukraine.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- ELISA test for the antibodies to COVID-2019.
- How many people
- 3,632 participants
- Where
- 7 sitesUkraine
- Study dates
- 16 Mar 2021to 23 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- The subject may not be included in the study due to non-compliance with the inclusion criteria or due to force majeure.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Ukraine7 sites
SI National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky
Kyiv, 03038
Institute Hyalual LLC
Kyiv, 03151
Yuria-Pharm LLC
Kyiv, 03151
Medical Center M.T.K. LLC
Kyiv, 03680
Infuzia PJSC
Kyiv, 04073
Diatom LLC
Kyiv, 04215
InterChem SLC
Odesa, 65000
About this study
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.
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.
Read the 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.
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.
- Conditions
- Covid19
- Being tested
- ELISA test for the antibodies to COVID-2019.
- Keywords
- Prevention, prophylactics, incidence, severity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
.
Measured: 1 visit from March 2021 till June 2021
Secondary outcomes (9)
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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).
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). 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 1 visit from March 2021 till June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start16 Mar 2021
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuria-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaxi LLC
- Responsible party
- Sponsor
- Investigators
- Tetiana Sprynsian, Study director, Yuria-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043142
- Sponsor's protocol ID
- EpidProtect-21
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05043142
- Acronym / sponsor ID
- EpidProtect-21
- Conditions
- Covid19
- Keywords
- Prevention, prophylactics, incidence, severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,632 participants (actual)
- Lead sponsor
- Yuria-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaxi LLC
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Posted 1 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- The subject may not be included in the study due to non-compliance with the inclusion criteria or due to force majeure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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). .
9 secondary outcomes
The Severity of the COVID-2019 Cases in Participating Organizations.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 visit from March 2021 till June 2021
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Ann Bowling. Research Methods in Health: Investigating Health and Health Services, Fourth edition, 2014, Maidenhead, GB. McGraw Hill; Open University Press, 536ppLink provided by the sponsor.
- Bernard Rosner. Fundamentals of Biostatistics, Seventh Edition, 2010.Link provided by the sponsor.
- Ann Aschengrau. Essentials of Epidemiology in Public Health, Fourth EditionLink provided by the sponsor.
- Bonita, Ruth, Beaglehole, Robert, Kjellström, Tord \& World Health Organization. (2006). Basic epidemiology, 2nd ed. World Health OrganizationLink provided by the sponsor.
- Earl Babbie. The Practice of Social Research, Twelfth edition, 2009Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetiana Sprynsian study director
Yuria-Pharm
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Yuria-Pharm at 7 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of COVID-2019 Cases. (time frame: 1 visit from March 2021 till June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.