NCT04413435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

May 25, 2020

Last Update Submit

December 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Polymerase Chain Reaction (PCR) test

    To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.

    5 days

Secondary Outcomes (1)

  • A scoring system for patients to be admitted to the intensive care unit

    5 days

Study Arms (2)

Confirmed COVID-19 cases

Patients with PCR test positive were considered as the confirmed COVID-19 cases.

Other: File Scanning

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

Interventions

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.

Confirmed COVID-19 casesSuspected COVID-19 cases

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailspatients \>18 years old
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • All patients \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Trainig and Research Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronavirus InfectionsCritical Illness

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 4, 2020

Study Start

October 30, 2020

Primary Completion

December 15, 2020

Study Completion

December 25, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Locations