Relationship Between Potential Predictors and Mortality i... | NCT04789460

Studies
Relationship Between Potential Predictors and Mortality in COVID-19 Patients ın Turkey

NCT04789460

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Completed

Last Update Posted

May 24, 2021Actual

Enrollment

816Actual

Phase

Not provided

Conditions

Covid19

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

May 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

Mar 5, 2021Actual

Primary Completion Date

Mar 28, 2021Actual

Completion Date

Mar 28, 2021Actual

First Submitted Date

Mar 4, 2021

First Submission Date that Met QC Criteria

Mar 8, 2021

First Posted Date

Mar 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

May 19, 2021

Last Update Posted Date

May 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

In this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of Covid-19 and to investigate their relationship with mortality.

Detailed Description

SARS-CoV-2 infection is effective in many countries and has caused pandemics. It is observed that it affects patients in a wide spectrum in terms of their clinical features worldwide. It is known that age, gender, and comorbidity play an important role in the course of the disease. Although mortality rates vary from country to country, there is no clear information due to the fact that the pandemic has not yet ended. In this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of Covid-19 and to investigate their relationship with mortality in Istanbul city which is the most affected by the pandemic in Turkey

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

816Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 patients in hospital		All patients aged 18 years and over, positive for SARS-CoV-2 PCR test and / or Covid-19 treatment with signs of Covid-19 disease on CT in two tertier hospital in Istanbul

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rate	up to 30 days after discharge	up to 30 days

Secondary Outcomes

Measure	Description	Time Frame
need for intensive care unit rate	need for intensive care unit during hospitalization	up to 30 days
length stay in hospital	number of length stay in hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who are 18 years of age and older, positive for SARS-CoV-2 PCR test and / or Covid-19 disease findings on CT will be included in the study.

Exclusion Criteria:

Patients with negative SARS-CoV-2 PCR test, pneumonia on CT but not given Covid-19 treatment by not considering Covid-19 by their doctor will not be included.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalized with the diagnosis of covid-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elif Yıldırım Ayaz, M.D.	Sultan Abdülhamid Han Training and Rsearch Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SBU Sultan Abdulhamid Han		Istanbul	Asia	34668	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided