Covid19NCT04816786
COVID-19 Patients Admitted to the ICU
An observational study of Covid19, run by Ministry of Health, Kuwait at 1 site in Kuwait.
Trial summary
A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 100 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Jan 2021to 1 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the hospital and suspected of having the COVID-19 virus. Patients who are positive on a PCR test are usually traiged to be managed on the wards Vs ICU (Intensive care unit). This is based on a number of parameters; including but not limited to The severity of the symptoms, vital signs, lab results, co-morbidities, age.
Who may be able to join
- Adults
- Positive PCR test for COVID-19
- Require admission to ICU
Who cannot join
- Pediatric patients\
- Any patient not requiring admission to ICU
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Mubarak al Kabeer hospital
Kuwait City, Outside U.S./Canada, 00000
Waleed burhamah, mb bch boa, 90004926, waleedburhamah1994@gmail.com
About this study
Official title: Prognostic Factors and Predictors of Mortality in COVID-19 Patients Admitted to the ICU. An Aid for Triage, Counseling, and Resource Allocation
A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded.
Variables collected will include Age, Gender, BMI, Smoking status, Past medical history, Vital signs on admission, symptoms on admission, duration of symptoms, laboratory results on admission, treatment given. Treatment options will include (Steroids, plasma exchange, IVIG, antibiotics, mode of respiratory support).
Read more
Primary outcomes will include; Death, duration of ICU stay, duration of mechanical ventilation, in-hospital complications.
A regression model will be used to predict poor prognostic factors. Inclusion criteria: patients with confirmed PCR results for COVID-19 AND require ICU admission. Exclusion criteria: those with negative results, pediatric patients and those not requiring ICU admission.
- Conditions
- Covid19
- Being tested
- no intervention will be administered, this is a retrospective observational study.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention will be administered, this is a retrospective observational study.Other
no intervention will be administered, this is a retrospective observational study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Admitted to ICU and died during the hospital stay. | Not described Receives: Other: no intervention will be administered, this is a retrospective observational study. | |
| Group 2: Admitted to ICU was were discharged. | Not described Receives: Other: no intervention will be administered, this is a retrospective observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death Vs No Death
Measured: 30 day mortality
Duration of ICU stay
Duration of ICU stay
Measured: 30 days
Duration of mechanical ventilation
The duration the patient required support from a mechanical ventilator
Measured: 30 days
Secondary outcomes (1)
In-Hospital complications
Wether patients developed in hospital complications.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Waleed burhamah, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816786
- Sponsor's protocol ID
- 1591/2020
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors and Predictors of Mortality in COVID-19 Patients Admitted to the ICU. An Aid for Triage, Counseling, and Resource Allocation
- ClinicalTrials.gov ID
- NCT04816786
- Acronym / sponsor ID
- 1591/2020
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 25 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.
A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded.
Variables collected will include Age, Gender, BMI, Smoking status, Past medical history, Vital signs on admission, symptoms on admission, duration of symptoms, laboratory results on admission, treatment given. Treatment options will include (Steroids, plasma exchange, IVIG, antibiotics, mode of respiratory support).
Primary outcomes will include; Death, duration of ICU stay, duration of mechanical ventilation, in-hospital complications.
A regression model will be used to predict poor prognostic factors. Inclusion criteria: patients with confirmed PCR results for COVID-19 AND require ICU admission. Exclusion criteria: those with negative results, pediatric patients and those not requiring ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Admitted to ICU and died during the hospital stay. | – | Other: no intervention will be administered, this is a retrospective observational study. |
| Group 2: Admitted to ICU was were discharged. | – | Other: no intervention will be administered, this is a retrospective observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the hospital and suspected of having the COVID-19 virus. Patients who are positive on a PCR test are usually traiged to be managed on the wards Vs ICU (Intensive care unit). This is based on a number of parameters; including but not limited to The severity of the symptoms, vital signs, lab results, co-morbidities, age.
Key inclusion criteria (3 listed)
- Adults
- Positive PCR test for COVID-19
- Require admission to ICU
Key exclusion criteria (2 listed)
- Pediatric patients\
- Any patient not requiring admission to ICU
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 will be administered, this is a retrospective observational study.no intervention will be administered, this is a retrospective observational study. | Other | Group 1: Admitted to ICU and died during the hospital stay., Group 2: Admitted to ICU was were discharged. |
Primary outcome
Death
Time frame: 30 day mortality
Death Vs No Death
Duration of ICU stay
Time frame: 30 days
Duration of ICU stay
Duration of mechanical ventilation
Time frame: 30 days
The duration the patient required support from a mechanical ventilator
1 secondary outcome
In-Hospital complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- 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.
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, run by Ministry of Health, Kuwait at 1 site in Kuwait.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. 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 Kuwait. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 day mortality). The study lists 3 primary outcomes in all. 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 25 Mar 2021.