NCT04805645

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

March 16, 2021

Last Update Submit

August 30, 2023

Conditions

Covid19Critically Ill

Keywords

COVID-19Critically illMortality Day 28

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Died before or on Day 28 after ICU admission

    28 days

Secondary Outcomes (1)

  • Oxygen supplementation requirement

    day 28

Study Arms (2)

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

No intervention (Retrospective Cohort Observational)OTHER

No intervention as this study is a Retrospective Cohort Observational

Non-Survivors

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia

Location

MeSH Terms

Conditions

COVID-19Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kean Khang Fong

    Hospital Queen Elizabeth, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)