SurvivalNCT04956562
Effect of Sinovac on Survival in Intensive Care Unit
An observational study of Survival and Intensive Care Unit, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Effect of Inactivated COVID-19 Vaccine (Sinovac) on survival in intensive care unit, Single Center Experience Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Survival, Intensive Care Unit
- Type of treatment
- Vaccines
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 15 May 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- Older adult
Study population: Patients admitted to our institution's intensive care unit (ICU) between 01 April 2021 and 15 May 2021 was enrolled to the study. Exclusion criteria was admissions to ICU due to reasons other than COVID-19, age younger than 18, continued admission at the end of enrolment date.
Who may be able to join
- Patients with covid 19 over the age of 65 who were admitted to the intensive care unit between 1 April 2021 and 15 May 2021
Who cannot join
- admissions to ICU due to reasons other than COVID-19, age younger than 65, continued admission at the end of enrolment date,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Research and Training Hospital
Istanbul, 34771
About this study
Official title: Effect of Inactivated COVID-19 Vaccine, Sinovac on Survival in Intensive Care Unit
Effect of Inactivated COVID-19 Vaccine (Sinovac) on survival in intensive care unit, Single Center Experience
Read the detailed description
Turkey has started vaccinate healthcare professionals at 13 January 2021 by Sinovac vaccine and declared a step by step inclusion schedule The primary aim of the study is to compare clinical, laboratory and survival data of COVID-19 patients who were vaccinated at least 14 days before enrollment to the study with COVID-19 patients not vaccinated although they would have. The secondary aim is to compare age of enrolled patients to ICU due to SARS-CoV-2 infection with patients admitted to ICU before start of vaccination program.
- Conditions
- Survival, Intensive Care Unit
- Keywords
- covid-19 vaccine, sinovac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated with sinovac | Vaccinated COVID-19 patients over 65 years consisted the study group | |
| Unvaccinated | Unvaccinated patients over 65 years composed the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival data
If the patient dies, we have reached an outcome
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Apr 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurvivalStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Acar Sevinç, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956562
- Sponsor's protocol ID
- 1903
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sevinc SA, Metin S, Basi NB, Ling J, Cinar AS, Oba S. Effectiveness of inactivated SARS-CoV-2 vaccine (CoronaVac) on intensive care unit survival. Epidemiol Infect. 2022 Feb 9;150:e35. doi: 10.1017/S0950268822000267.
PubMed 35135644
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inactivated COVID-19 Vaccine, Sinovac on Survival in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04956562
- Acronym / sponsor ID
- 1903
- Conditions
- Survival, Intensive Care Unit
- Keywords
- covid-19 vaccine, sinovac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 9 Jul 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.
Effect of Inactivated COVID-19 Vaccine (Sinovac) on survival in intensive care unit, Single Center Experience
Detailed description
Turkey has started vaccinate healthcare professionals at 13 January 2021 by Sinovac vaccine and declared a step by step inclusion schedule The primary aim of the study is to compare clinical, laboratory and survival data of COVID-19 patients who were vaccinated at least 14 days before enrollment to the study with COVID-19 patients not vaccinated although they would have. The secondary aim is to compare age of enrolled patients to ICU due to SARS-CoV-2 infection with patients admitted to ICU before start of vaccination program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated with sinovac | – | –Vaccinated COVID-19 patients over 65 years consisted the study group |
| Unvaccinated | – | –Unvaccinated patients over 65 years composed the control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients admitted to our institution's intensive care unit (ICU) between 01 April 2021 and 15 May 2021 was enrolled to the study. Exclusion criteria was admissions to ICU due to reasons other than COVID-19, age younger than 18, continued admission at the end of enrolment date.
Key inclusion criteria (1 listed)
- Patients with covid 19 over the age of 65 who were admitted to the intensive care unit between 1 April 2021 and 15 May 2021
Key exclusion criteria (1 listed)
- admissions to ICU due to reasons other than COVID-19, age younger than 65, continued admission at the end of enrolment date,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival data
Time frame: 30 days
If the patient dies, we have reached an outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Derived from this study: PubMed 35135644Sevinc SA, Metin S, Basi NB, Ling J, Cinar AS, Oba S. Effectiveness of inactivated SARS-CoV-2 vaccine (CoronaVac) on intensive care unit survival. Epidemiol Infect. 2022 Feb 9;150:e35. doi: 10.1017/S0950268822000267.
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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.
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?
An observational study of Survival and Intensive Care Unit, run by Sisli Hamidiye Etfal Training and Research Hospital 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 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 9 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
survival data (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956562, which also lists 1 linked publication.
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 9 Jul 2021.