Coronavirus as the Cause of Diseases Classified ElsewhereNCT04383483
CoV-ICU Score, Intensive Care Unit, SARS-CoV-2
An observational study of Coronavirus as the Cause of Diseases Classified Elsewhere, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronavirus as the Cause of Diseases Classified Elsewhere
- What is being tested?
- COVICU
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 28 Feb 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the intensive care unit with the diagnosis of COVID
Who may be able to join
- Patients admitted to the intensive care unit with the diagnosis of COVID
Who cannot join
- <18 years patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Yüksek Ihtisas Training and Research Hospital
Bursa, Yildirim, 16350
Ali Asan, MD, +905332401067, draasan@yahoo.com
Halil Erkan Sayan, MD, +905325972556, erkansayan@hotmail.com
About this study
Official title: CoV-ICU Score: Who Will Need Intensive Care in the Course of Corona Virus Disease?
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.
Read the 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.
- Being tested
- COVICU
- Keywords
- SARS-CoV-2, intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVICUOther
COVICU
| Study group | Role | What they receive |
|---|---|---|
| CoVID patients admitted to ICU | Patients admitted to the intensive care unit with the diagnosis of COVID Receives: Other: COVICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Values
Minimum and maximum values will be determined at the end of the study. Higher scores mean a worse outcome
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 Jun 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus as the Cause of Diseases Classified ElsewhereStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ali ASAN, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ali Asan, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383483
- Sponsor's protocol ID
- BYIEAH-202005
- Status last verified
- Mar 2021
- First submitted
- 7 May 2020
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoV-ICU Score: Who Will Need Intensive Care in the Course of Corona Virus Disease?
- ClinicalTrials.gov ID
- NCT04383483
- Acronym / sponsor ID
- BYIEAH-202005
- Keywords
- SARS-CoV-2, intensive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 12 May 2020 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoVID patients admitted to ICU | – | Other: COVICUPatients admitted to the intensive care unit with the diagnosis of COVID |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the intensive care unit with the diagnosis of COVID
Key inclusion criteria (1 listed)
- Patients admitted to the intensive care unit with the diagnosis of COVID
Key exclusion criteria (1 listed)
- <18 years patients
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 |
|---|---|---|
| COVICUCOVICU | Other | CoVID patients admitted to ICU |
Primary outcome
COVICU score
Time frame: 1 week
With this scoring, identifying patients who may need intensive care early and following them closely will have a positive effect on patient prognosis.
Values
Time frame: 1 week
Minimum and maximum values will be determined at the end of the study. Higher scores mean a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Yes
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.
Ali Asan, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
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 Coronavirus as the Cause of Diseases Classified Elsewhere, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 29 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 Turkey (Türkiye). 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?
Contact Ali Asan, MD (+905332401067, draasan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVICU score (time frame: 1 week). The study lists 2 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 29 Mar 2021.