Risk Factors for Mortality for COVID-19 Admitted to an In... | NCT04805645

Studies
Risk Factors for Mortality for COVID-19 Admitted to an Intensive Care Unit

NCT04805645

Sponsor

Clinical Research Centre, Malaysia

Status

Terminated

Last Update Posted

Sep 1, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Covid19
Critically Ill

Interventions

No intervention (Retrospective Cohort Observational)

Countries

Malaysia

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was unable to begin due to clinicians too busy with handling COVID-19 cases

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Mar 16, 2021

First Submission Date that Met QC Criteria

Mar 16, 2021

First Posted Date

Mar 18, 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

Aug 30, 2023

Last Update Posted Date

Sep 1, 2023Actual

Name	Class
Hospital Queen Elizabeth, Malaysia	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

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

Studying clinical characterization of critically ill COVID-19 patients in a single center Studying Risk factors for Day 28 Mortality in COVID-19 patients admitted to intensive care unit

Detailed Description

An observational study looking into clinical characterization of the novel Coronavirus Disease 2019 (COVID-19) in patients admitted, critically ill, into Intensive Care Unit of Hospital Queen Elizabeth between 1st October 2020 until 31st January 2021. Analysis also would be looking into the risk factors into Day 28 mortality of these patients

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Survivors		Participants who had Critically-ill COVID-19 and admitted to the Intensive Care Unit which died before or on day 28 post ICU admission	Other: No intervention (Retrospective Cohort Observational)
Survivors		Participants who had Critically-ill COVID-19 and admitted to the Intensive Care Unit whom are still alive on day 28 post ICU admission

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention (Retrospective Cohort Observational)	Other	No intervention as this study is a Retrospective Cohort Observational	Non-Survivors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Died before or on Day 28 after ICU admission	28 days

Secondary Outcomes

Measure	Description	Time Frame
Oxygen supplementation requirement	Requirement of oxygen supplementation on day 28 after icu admission	day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021
Confirmed COVID-19 Positive using RT-PCR or RTK-Ag either before or during admission in ICU

Exclusion Criteria:

Patients that were admitted in ICU suspected to have COVID-19 and died in ICU which subsequently to be COVID-19 negative

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021, which confirmed to have via PCR testing or Rapid Test Antigen are positive for PCR

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kean Khang Fong	Hospital Queen Elizabeth, Malaysia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Queen Elizabeth		Kota Kinabalu			Malaysia

IPD Sharing Statement Module

Plan to Share IPD

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
D016638	Critical Illness

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided