Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Characteristics of Critically Ill Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413435
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mehmet Akif Yazar, Nevsehir Public Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronavirus Infection Critical Illness Characteristics Disease Other: File Scanning

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Clinical Characteristics of Critically Ill Patients With 2019 Novel Coronavirus (COVID-19): Do We Need a New Triage System?
Estimated Study Start Date : October 30, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Confirmed COVID-19 cases
Patients with PCR test positive were considered as the confirmed COVID-19 cases.
Other: File Scanning
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.
Other: File Scanning
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.




Primary Outcome Measures :
  1. Polymerase Chain Reaction (PCR) test [ Time Frame: 5 days ]
    To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients >18 years old
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.
Criteria

Inclusion Criteria:

  • All patients with confirmed COVID-19 and suspected COVID-19

Exclusion Criteria:

  • All patients <18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413435


Contacts
Layout table for location contacts
Contact: Yasin Tire, Dr 090 5055665758 dryasintire@hotmail.com
Contact: Betül Kozanhan, Dr 090 5055665758 betulkozanhan@gmail.com

Locations
Layout table for location information
Turkey
Konya Trainig and Research Hospital Recruiting
Konya, Turkey
Contact: Yasin Tire, Dr    0905055665758    dryasintire@hotmail.com   
Sponsors and Collaborators
Nevsehir Public Hospital
Layout table for additonal information
Responsible Party: Mehmet Akif Yazar, Specialist, Nevsehir Public Hospital
ClinicalTrials.gov Identifier: NCT04413435    
Other Study ID Numbers: 2020-245
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Critical Illness
Disease Attributes
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases