- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413435
Clinical Characteristics of Critically Ill Patients With COVID-19
December 30, 2020 updated by: Mehmet Akif Yazar, Nevsehir Public Hospital
Clinical Characteristics of Critically Ill Patients With 2019 Novel Coronavirus (COVID-19): Do We Need a New Triage System?
Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy.
In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system.
Hence, it may be need a new scoring system for contagious critically ill patients.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy.
In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system.
Therefore, many patients with confirmed COVID-19 with RT-PCR and/or suspected COVID-19 were hospitalized in ICUs with a limited number of beds.
This ambiguity can result in both contamination risk to uninfected patients and occupancy rate of the limited ICU beds.
Hence, it may be need a new scoring system for contagious critically ill patients.
The aim of this study was to describe the epidemiological and clinical features of 75 critically ill patients due to COVID-19 and to compare confirmed COVID-19 cases with suspected COVID-19 cases in our critical care units.
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Konya, Turkey
- Konya Trainig and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with confirmed COVID-19 and suspected COVID-19 patients who hospitalized in ICUs allocated for patients with novel coronavirus disease.
Description
Inclusion Criteria:
- All patients with confirmed COVID-19 and suspected COVID-19
Exclusion Criteria:
- All patients <18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Confirmed COVID-19 cases
Patients with PCR test positive were considered as the confirmed COVID-19 cases.
|
The patients' epidemiological, clinical, laboratory, and radiological characteristics and treatment and outcomes data will accessed from Hospital Data Management System (HDMS) of Konya Training and Research Hospital and Public Health Management System (PHMS) of Ministry of Health.
|
|
Suspected COVID-19 cases
The suspected COVID-19 cases were defined as follows: those who were interpreted in favor of the suspected covid-19 on c-CT by radiologists in addition to the typical symptoms of the novel coronavirus disease such as cough, high fever (>38,5 °C), or dyspnea, and those with a history of contact with another confirmed COVID-19 patient in addition to typical symptoms.
|
The patients' epidemiological, clinical, laboratory, and radiological characteristics and treatment and outcomes data will accessed from Hospital Data Management System (HDMS) of Konya Training and Research Hospital and Public Health Management System (PHMS) of Ministry of Health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Polymerase Chain Reaction (PCR) test
Time Frame: 5 days
|
To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A scoring system for patients to be admitted to the intensive care unit
Time Frame: 5 days
|
To use symptoms, medical history, computed tomography and laboratory examinations for scoring system to detect suspected COVID-19 cases admitted to the intensive care units.
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 30, 2020
Primary Completion (ACTUAL)
December 15, 2020
Study Completion (ACTUAL)
December 25, 2020
Study Registration Dates
First Submitted
May 25, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (ACTUAL)
June 4, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 5, 2021
Last Update Submitted That Met QC Criteria
December 30, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-245
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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