NCT04430023

Brief Summary

In this study, the investigator examined epidemiological and demographic characteristics, risk factors and 28-day mortality of patients admitted to the intensive care unit with the diagnosis of coronavirus disease 2019 pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 15, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

19 days

First QC Date

June 10, 2020

Last Update Submit

June 12, 2020

Conditions

Keywords

coronavirus disease 2019pneumonia

Outcome Measures

Primary Outcomes (2)

  • mortality

    mortality rate

    up to 28 days

  • demographic characteristics

    Patients' age, gender, BMI, medical history

    up to 28 days

Interventions

Patients' age, gender, BMI, medical history, symptoms at admission (e.g., cough, fever, myalgia, gastrointestinal symptoms, headache), concomitant diseases (e.g., diabetes mellitus, hypertension, chronic lung disease, cerebrovascular disease, kidney disease, heart disease, cancer, smoking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was planned retrospectively, cross-sectionally and observationally with 193 patients hospitalized between 16 March 2020 and 15 May 2020 in five different coronavirus disease 2019 intensive care units in two campuses of our hospital.

You may qualify if:

  • The study was planned retrospectively, cross-sectionally and observationally with 193 patients hospitalized between 16 March 2020 and 15 May 2020 in five different coronavirus disease 2019 intensive care units in two campuses of our hospital.

You may not qualify if:

  • Health workers, patients hospitalized less than 24 hours, patients with negative polymerase chain reaction tests, and patients who returned to intensive care unit after discharge were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Research and Training Hospital

Istanbul, Marmara, 34371, Turkey (Türkiye)

Location

Related Publications (3)

  • Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.

  • Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

  • Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.

MeSH Terms

Conditions

Coronavirus InfectionsPneumoniaCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPneumonia, Viral

Study Officials

  • ayse cinar

    chief of anesthesia department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of anesthesiology

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

May 15, 2020

Primary Completion

June 3, 2020

Study Completion

June 5, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations