NCT04956562

Brief Summary

Effect of Inactivated COVID-19 Vaccine (Sinovac) on survival in intensive care unit, Single Center Experience

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
Last Updated

July 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

June 30, 2021

Last Update Submit

June 30, 2021

Conditions

Keywords

covid-19 vaccinesinovac

Outcome Measures

Primary Outcomes (1)

  • survival data

    If the patient dies, we have reached an outcome

    30 days

Study Arms (2)

Vaccinated with sinovac

Vaccinated COVID-19 patients over 65 years consisted the study group

Unvaccinated

Unvaccinated patients over 65 years composed the control group

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, 34771, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant doctor

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 9, 2021

Study Start

April 1, 2021

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

July 9, 2021

Record last verified: 2021-06

Locations