Effect of Sinovac on Survival in Intensive Care Unit | NCT04956562

Studies
Effect of Sinovac on Survival in Intensive Care Unit

NCT04956562

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Last Update Posted

Jul 9, 2021Actual

Enrollment

96Actual

Phase

Not provided

Conditions

Survival
Intensive Care Unit

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

May 15, 2021Actual

Completion Date

May 15, 2021Actual

First Submitted Date

Jun 30, 2021

First Submission Date that Met QC Criteria

Jun 30, 2021

First Posted Date

Jul 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2021

Last Update Posted Date

Jul 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sultan Acar Sevinç, consultant doctor, Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccinated with sinovac		Vaccinated COVID-19 patients over 65 years consisted the study group
Unvaccinated		Unvaccinated patients over 65 years composed the control group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival data	If the patient dies, we have reached an outcome	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

admissions to ICU due to reasons other than COVID-19, age younger than 65, continued admission at the end of enrolment date,

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sisli Hamidiye Etfal Research and Training Hospital		Istanbul		34771	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35135644	Derived	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.