CoV-ICU Score, Intensive Care Unit, SARS-CoV-2 | NCT04383483

Studies
CoV-ICU Score, Intensive Care Unit, SARS-CoV-2

NCT04383483

Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Status

Unknown status

Last Update Posted

Mar 29, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Coronavirus as the Cause of Diseases Classified Elsewhere

Interventions

COVICU

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2020Actual

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

May 7, 2020

First Posted Date

May 12, 2020Actual

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

Mar 26, 2021

Last Update Posted Date

Mar 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ali ASAN, Associate professor, Bursa Yuksek Ihtisas Training and Research HospitalPrincipal Investigator

Lead Sponsor

Bursa Yuksek Ihtisas Training and Research HospitalOTHER_GOV

Collaborators

Not provided

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 the course of COVID disease, some patients need intensive care treatment. We aim to find an answer to the question of whether the patient's CRP, ferritin, D-dimer, Oxygen Saturation, lymphocyte count, and body mass index can be used as a criterion for admitting patients with COVID to the intensive see unit.

Detailed Description

It is aimed to determine the patients who are above the threshold value to be determined according to this scoring result. Identifying patients who may need intensive care and following them closely will positively affect patient prognosis.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CoVID patients admitted to ICU		Patients admitted to the intensive care unit with the diagnosis of COVID	Other: COVICU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVICU	Other	COVICU	CoVID patients admitted to ICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COVICU score	With this scoring, identifying patients who may need intensive care early and following them closely will have a positive effect on patient prognosis.	1 week
Values	Minimum and maximum values will be determined at the end of the study. Higher scores mean a worse outcome	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the intensive care unit with the diagnosis of COVID

Exclusion Criteria:

<18 years patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

All patients admitted to the intensive care unit with the diagnosis of COVID

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ali Asan, MD	Contact	+905332401067		draasan@yahoo.com
Erkan Sayan, MD	Contact	+905325972556		erkansayan@hotmail.com

Overall Officials

Name	Affiliation	Role
Ali Asan, MD	Bursa Yuksek Ihtisas Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bursa Yüksek Ihtisas Training and Research Hospital	Recruiting	Bursa	Yildirim	16350	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided