Covid-19 VaccineNCT04751721
Oxidative Stress Parameters, Trace Element and Quality of Life in Women Before and After Covid-19 Vaccines
A study testing CoronoVac Vaccine in people with Covid-19 Vaccine, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
There is no effective treatment method for COVID-19 yet. With vaccination being the most effective approach to control the COVID-19 pandemic, vaccines have been developed with many different methods. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid-19 Vaccine
- What is being tested?
- CoronoVac Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2021to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to voluntarily participate in the study
Who cannot join
- Have been taking trace element supplements for the past 2 weeks
- Being pregnant
- Body mass index over 40 kg/m2
- Diagnosed with Covid-19 in advance
- Not diagnosed with any chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Oxidative Stress Parameters, Trace, Element and Quality of Life Levels in Healthy Women Before and After Covid-19 Vaccines
There is no effective treatment method for COVID-19 yet. With vaccination being the most effective approach to control the COVID-19 pandemic, vaccines have been developed with many different methods. One of the vaccines developed, the China-based CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classical vaccine production method. As a result of Phase 1, Phase 2 and Phase 3 trials, emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency. The clinical picture of COVID-19 can be heterogeneous, ranging from asymptomatic to severe disease, which can be associated with a cytokine storm. In the clinical results of COVID-19, it has been observed that the severity of the disease is lower in women than in men, and the mortality rates are lower in women than in men. A few studies have shown the physiological roles of some vitamins and trace elements in COVID-19. Investigation of free radical levels known to be effective in the development of cardiovascular disease due to oxidative stress is important in determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the social isolation rules and quarantine measures applied in the COVID-19 pandemic have caused individuals to be negatively affected physically and psychologically and their quality of life to decrease. Investigating the changes in oxidative stress parameters, trace element and quality of life levels of vaccination in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. It is planned to include female individuals to be vaccinated in Izmir Bakırcay University Cigli Training and Research Hospital. Within the scope of the study, it was planned to determine the oxidative stress parameters, trace element levels and quality of life levels of the individuals and to compare the values of the data obtained before and after vaccination. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Read the detailed description
Coronavirus disease 2019 (COVID-19) pandemic, also known as Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), caused by a coronavirus strain that is a member of the Betacoronavirus genus, affecting billions of people worldwide, has become a global health problem. Since vaccination is the most effective approach to control the COVID-19 pandemic, trials of many different vaccines have been started.
According to the data of the World Health Organization, there are 236 vaccines in total, with clinical (63) and pre-clinical (173) studies developed using 10 different methods.Types of vaccines for COVID-19 include conventionally live attenuated viruses, inactivated virus protein or polysaccharide conjugated subunit vaccines, virus-like particles (VLPs), nucleic acid (DNA and RNA), viral vectors (replicating and non-replicating), and the other vaccines composed of eccombinant proteins.
CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed by the biopharmaceutical company named Sinovac Biotech Ltd. based in China, using the classical vaccine production method (inactive method). After the completion of Phase 1 and Phase 2 trials of the vaccine, Phase 3 trials were initiated in Turkey. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency after the end of these trials.Although the pathogenesis of COVID-19 is not fully understood, its clinical presentation may become heterogeneous, ranging from asymptomatic to severe disease.
It has been reported that a systemic hyperinflammatory response and associated thromboembolic complications are observed in cases with severe symptoms. In addition, it has been observed that the severity of the disease and mortality rates are lower in women compared to men in the clinical results of COVID-19.
The roles of vitamins A, B, C, D, E and folate and trace elements such as iron, zinc, magnesium, selenium and copper in supporting the immune system have been shown to have positive effects on COVID-19 disease.
Intermediates in enzymatic reactions occurring during cell metabolism (reactive oxygen species and reactive nitrogen) sometimes leak from the active site of enzymes and accidentally interact with molecular oxygen and form free oxygen radicals. Oxidative stress caused by free oxygen radicals forms the molecular basis in the development of cancer, neurodegenerative and cardiovascular diseases, diabetes and autoimmune disorders.
Social isolation rules and quarantine measures have negatively affected the daily lives of individuals physically and psychologically. In particular, the increase in the time spent at home causes individuals to have a sedentary life and cause their physical levels to decrease. This situation caused individuals to be psychologically affected by concerns about health, news watched, and the increasing number of cases day by day.
Studies have also reported negative psychological effects such as post-traumatic stress symptoms, confusion, disappointment, feeling of isolation and anger as a result of quarantine. These psychological and physical effects caused by the COVID-19 pandemic caused a decrease in the quality of life of individuals. During the COVID-19 pandemic, it has been reported that the depression and anxiety levels of healthcare workers increased and their quality of life decreased.
The aim of this study is to compare and determined and the changes of oxidative stress parameters, trace element and quality of life levels in healthy women just before the first dose of COVID-19 vaccine and on the 7th day after the second dose of COVID19 vaccine.
- Conditions
- Covid-19 Vaccine
- Being tested
- CoronoVac Vaccine
- Keywords
- Covid-19, CoronaVac vaccine, Healthy women
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronoVac VaccineBiological
CoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days.
| Study group | Role | What they receive |
|---|---|---|
| CoronoVac Vaccine Group | Experimental | Not described Receives: Biological: CoronoVac Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the levels of Oxidative Stress Parameter 1
Oxidative Stress Parameter including Superoxide Dismutase (SOD) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of Oxidative Stress Parameter 2
Oxidative Stress Parameters including Malondialdehyde (MDA) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of Oxidative Stress Parameter 3
Oxidative Stress Parameter including Total Antioxidant Level (TAL) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of Oxidative Stress Parameter 4
Oxidative Stress Parameters including Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 1
Serum trace element including zinc levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 2
Serum trace elements including selenium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 3
Serum trace element including potassium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 4
Serum trace element including sodium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 5
Serum trace elements including calcium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 6
Serum trace element including magnesium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 7
Serum trace element including copper levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of quality of life
SF-36 Quality of Life Scale will be used to determine the quality of life level. The scale that patients can apply themselves and in a short time; It consists of 36 items and 8 subsections. These sections are physical functionality, social functionality, role restrictions due to physical problems, role restrictions due to emotional problems, pain, energy level / vitality / vitality, mental health, and general health perception (40). The last 4 weeks are considered in the evaluation of the scale. The scale gives a separate total score for each subsection. The points obtained from the subsections are not added up. Subdivisions rate health from 0 to 100. While it expresses bad health status as "0 points", it refers to good health status as "100 points".
Measured: Immediately before the first dose and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 VaccineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Cigli Regional Training Hospital, Muğla Sıtkı Koçman University
- Responsible party
- Principal investigator, Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751721
- Sponsor's protocol ID
- 2021-01-173
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxidative Stress Parameters, Trace, Element and Quality of Life Levels in Healthy Women Before and After Covid-19 Vaccines
- ClinicalTrials.gov ID
- NCT04751721
- Acronym / sponsor ID
- 2021-01-173
- Conditions
- Covid-19 Vaccine
- Keywords
- Covid-19, CoronaVac vaccine, Healthy women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Cigli Regional Training Hospital, Muğla Sıtkı Koçman University
- Study start
- Feb 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is no effective treatment method for COVID-19 yet. With vaccination being the most effective approach to control the COVID-19 pandemic, vaccines have been developed with many different methods. One of the vaccines developed, the China-based CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classical vaccine production method. As a result of Phase 1, Phase 2 and Phase 3 trials, emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency. The clinical picture of COVID-19 can be heterogeneous, ranging from asymptomatic to severe disease, which can be associated with a cytokine storm. In the clinical results of COVID-19, it has been observed that the severity of the disease is lower in women than in men, and the mortality rates are lower in women than in men. A few studies have shown the physiological roles of some vitamins and trace elements in COVID-19. Investigation of free radical levels known to be effective in the development of cardiovascular disease due to oxidative stress is important in determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the social isolation rules and quarantine measures applied in the COVID-19 pandemic have caused individuals to be negatively affected physically and psychologically and their quality of life to decrease. Investigating the changes in oxidative stress parameters, trace element and quality of life levels of vaccination in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. It is planned to include female individuals to be vaccinated in Izmir Bakırcay University Cigli Training and Research Hospital. Within the scope of the study, it was planned to determine the oxidative stress parameters, trace element levels and quality of life levels of the individuals and to compare the values of the data obtained before and after vaccination. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Detailed description
Coronavirus disease 2019 (COVID-19) pandemic, also known as Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), caused by a coronavirus strain that is a member of the Betacoronavirus genus, affecting billions of people worldwide, has become a global health problem. Since vaccination is the most effective approach to control the COVID-19 pandemic, trials of many different vaccines have been started.
According to the data of the World Health Organization, there are 236 vaccines in total, with clinical (63) and pre-clinical (173) studies developed using 10 different methods.Types of vaccines for COVID-19 include conventionally live attenuated viruses, inactivated virus protein or polysaccharide conjugated subunit vaccines, virus-like particles (VLPs), nucleic acid (DNA and RNA), viral vectors (replicating and non-replicating), and the other vaccines composed of eccombinant proteins.
CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed by the biopharmaceutical company named Sinovac Biotech Ltd. based in China, using the classical vaccine production method (inactive method). After the completion of Phase 1 and Phase 2 trials of the vaccine, Phase 3 trials were initiated in Turkey. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency after the end of these trials.Although the pathogenesis of COVID-19 is not fully understood, its clinical presentation may become heterogeneous, ranging from asymptomatic to severe disease.
It has been reported that a systemic hyperinflammatory response and associated thromboembolic complications are observed in cases with severe symptoms. In addition, it has been observed that the severity of the disease and mortality rates are lower in women compared to men in the clinical results of COVID-19.
The roles of vitamins A, B, C, D, E and folate and trace elements such as iron, zinc, magnesium, selenium and copper in supporting the immune system have been shown to have positive effects on COVID-19 disease.
Intermediates in enzymatic reactions occurring during cell metabolism (reactive oxygen species and reactive nitrogen) sometimes leak from the active site of enzymes and accidentally interact with molecular oxygen and form free oxygen radicals. Oxidative stress caused by free oxygen radicals forms the molecular basis in the development of cancer, neurodegenerative and cardiovascular diseases, diabetes and autoimmune disorders.
Social isolation rules and quarantine measures have negatively affected the daily lives of individuals physically and psychologically. In particular, the increase in the time spent at home causes individuals to have a sedentary life and cause their physical levels to decrease. This situation caused individuals to be psychologically affected by concerns about health, news watched, and the increasing number of cases day by day.
Studies have also reported negative psychological effects such as post-traumatic stress symptoms, confusion, disappointment, feeling of isolation and anger as a result of quarantine. These psychological and physical effects caused by the COVID-19 pandemic caused a decrease in the quality of life of individuals. During the COVID-19 pandemic, it has been reported that the depression and anxiety levels of healthcare workers increased and their quality of life decreased.
The aim of this study is to compare and determined and the changes of oxidative stress parameters, trace element and quality of life levels in healthy women just before the first dose of COVID-19 vaccine and on the 7th day after the second dose of COVID19 vaccine.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoronoVac Vaccine Group | Experimental | Biological: CoronoVac Vaccine |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agree to voluntarily participate in the study
Key exclusion criteria (5 listed)
- Have been taking trace element supplements for the past 2 weeks
- Being pregnant
- Body mass index over 40 kg/m2
- Diagnosed with Covid-19 in advance
- Not diagnosed with any chronic disease
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 |
|---|---|---|
| CoronoVac VaccineCoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days. | Biological | CoronoVac Vaccine Group |
Primary outcome
Change of the levels of Oxidative Stress Parameter 1
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameter including Superoxide Dismutase (SOD) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 2
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameters including Malondialdehyde (MDA) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 3
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameter including Total Antioxidant Level (TAL) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 4
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameters including Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels serum trace element 1
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including zinc levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 2
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace elements including selenium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 3
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including potassium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 4
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including sodium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 5
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace elements including calcium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 6
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including magnesium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 7
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including copper levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels of quality of life
Time frame: Immediately before the first dose and 4 weeks later
SF-36 Quality of Life Scale will be used to determine the quality of life level. The scale that patients can apply themselves and in a short time; It consists of 36 items and 8 subsections. These sections are physical functionality, social functionality, role restrictions due to physical problems, role restrictions due to emotional problems, pain, energy level / vitality / vitality, mental health, and general health perception (40). The last 4 weeks are considered in the evaluation of the scale. The scale gives a separate total score for each subsection. The points obtained from the subsections are not added up. Subdivisions rate health from 0 to 100. While it expresses bad health status as "0 points", it refers to good health status as "100 points".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Related trials for Covid-19 Vaccine
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoronoVac Vaccine in people with Covid-19 Vaccine, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Change of the levels of Oxidative Stress Parameter 1 (time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine). The study lists 12 primary outcomes in all. 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 12 Feb 2021.