Covid19NCT04480060
Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic
An observational study of Covid19, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 diagnostic PCR
- How many people
- 100,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2020to 14 Jul 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All patients who followed up in emergency department ICU's of study centers with the diagnosis of COVID-19
Who may be able to join
- All patients who followed up in emergency department ICU with the diagnosis of COVID-19
- Accepted to participate with an informed consent
Who cannot join
- Patients under the age of 18 or more than 50 years
- declined to participate
- deaths caused by other than COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic: Retrospective Cohort Study
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.
Read the detailed description
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Throughout the pandemic, many patients, including COVID-19 patients, were successfully followed up and discharged from EICU. With this study, the investigators expect to show the role of EICU during the pandemic. In addition, it will be seen that whether the patients, who are waiting for hospitalization or waiting for referral, are admitted to EICU faster and their treatments will be started promptly. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.
- Conditions
- Covid19
- Being tested
- COVID-19 diagnostic PCR
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 diagnostic PCRDiagnostic test
Nasopharyngeal swab samples will be analyzed by PCR for COVID-19 DNA existence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality of the COVID-19 patients
Mortality of the COVID-19 patients who followed up by emergency department ICU
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start10 Mar 2020
- Primary completion30 Jun 2020
- Study completion14 Jul 2020
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
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Guven, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480060
- Sponsor's protocol ID
- KSSEAH--EDCC
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04480060
- Acronym / sponsor ID
- KSSEAH--EDCC
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 21 Jul 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.
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.
Detailed description
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Throughout the pandemic, many patients, including COVID-19 patients, were successfully followed up and discharged from EICU. With this study, the investigators expect to show the role of EICU during the pandemic. In addition, it will be seen that whether the patients, who are waiting for hospitalization or waiting for referral, are admitted to EICU faster and their treatments will be started promptly. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients who followed up in emergency department ICU's of study centers with the diagnosis of COVID-19
Key inclusion criteria (2 listed)
- All patients who followed up in emergency department ICU with the diagnosis of COVID-19
- Accepted to participate with an informed consent
Key exclusion criteria (3 listed)
- Patients under the age of 18 or more than 50 years
- declined to participate
- deaths caused by other than COVID-19
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 |
|---|---|---|
| COVID-19 diagnostic PCRNasopharyngeal swab samples will be analyzed by PCR for COVID-19 DNA existence. | Diagnostic test | – |
Primary outcome
Mortality of the COVID-19 patients
Time frame: 3 months
Mortality of the COVID-19 patients who followed up by emergency department ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kanuni Sultan Suleyman 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of the COVID-19 patients (time frame: 3 months). 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 21 Jul 2020.