Covid19ICUCOVID-KKNCT04805645
Risk Factors for Mortality for COVID-19 Admitted to an Intensive Care Unit
An observational study of Covid19 and Critically Ill, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Critically Ill
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2021to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Patients that were admitted in ICU suspected to have COVID-19 and died in ICU which subsequently to be COVID-19 negative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characteristics & Risk Factors for Mortality of COVID-19 Patients Admitted Into Intensive Care Unit in Hospital Queen Elizabeth
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
Read the 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
- Conditions
- Covid19, Critically Ill
- Being tested
- No intervention (Retrospective Cohort Observational)
- Keywords
- COVID-19, Critically ill, Mortality Day 28
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (Retrospective Cohort Observational)Other
No intervention as this study is a Retrospective Cohort Observational
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Died before or on Day 28 after ICU admission
Measured: 28 days
Secondary outcomes (1)
Oxygen supplementation requirement
Requirement of oxygen supplementation on day 28 after icu admission
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2021
- Study completion1 May 2021
Why it stopped: Study was unable to begin due to clinicians too busy with handling COVID-19 cases
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Queen Elizabeth, Malaysia
- Responsible party
- Sponsor
- Investigators
- Kean Khang Fong, Principal investigator, Hospital Queen Elizabeth, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805645
- Sponsor's protocol ID
- ICUCOVID-KK
- Acronym
- ICUCOVID-KK
- Status last verified
- Aug 2023
- First submitted
- 16 Mar 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics & Risk Factors for Mortality of COVID-19 Patients Admitted Into Intensive Care Unit in Hospital Queen Elizabeth
- ClinicalTrials.gov ID
- NCT04805645
- Acronym / sponsor ID
- ICUCOVID-KK / ICUCOVID-KK
- Conditions
- Covid19, Critically Ill
- Keywords
- COVID-19, Critically ill, Mortality Day 28
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was unable to begin due to clinicians too busy with handling COVID-19 cases
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Hospital Queen Elizabeth, Malaysia
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Survivors | – | Other: No intervention (Retrospective Cohort Observational)Participants who had Critically-ill COVID-19 and admitted to the Intensive Care Unit which died before or on day 28 post ICU admission |
| 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients that were admitted in ICU suspected to have COVID-19 and died in ICU which subsequently to be COVID-19 negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (Retrospective Cohort Observational)No intervention as this study is a Retrospective Cohort Observational | Other | Non-Survivors |
Primary outcome
Mortality
Time frame: 28 days
Died before or on Day 28 after ICU admission
1 secondary outcome
Oxygen supplementation requirement
Time frame: day 28
Results and safety
The study was stopped early (reason given: Study was unable to begin due to clinicians too busy with handling COVID-19 cases). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kean Khang Fong principal investigator
Hospital Queen Elizabeth, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Critically Ill, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was unable to begin due to clinicians too busy with handling COVID-19 cases). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.