NCT04789447

Brief Summary

This study aims to determine whether patients with different real-time reverse transcriptase-polymerase chain reaction (PCR), chest computed tomography (CT) and laboratory findings have different clinical outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
895

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

March 4, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

March 4, 2021

Last Update Submit

June 4, 2021

Conditions

Keywords

COVID-19SARS-CoV2 RT-PCR TestingThoraxComputerized TomographyMortalityPrognosis

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality during hospitalization and within 14 days after hospitalization

    up to 30 days

Secondary Outcomes (2)

  • need for intensive care

    up to 30 days

  • need for intenvasive mechanical ventilation

    up to 30 days

Study Arms (1)

COVID-19 patients in hospital

All patients aged 18 years and over, positive for SARS-CoV-2 PCR test and / or Covid-19 treatment with signs of Covid-19 disease on CT

Eligibility Criteria

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

Patients who are diagnosed with Covid-19 in a two tertier hospital in Turkey

You may qualify if:

  • Aged 18 years and over,
  • Having SARS-CoV-2 RT-PCR test and chest CT examinations performed at the time of application or within 24 hours after admission
  • RT-PCR positivity in nasopharyngeal swabs sample, and/or the presence of clinical and laboratory findings of SARS-CoV-2 infection and/or the presence of COVID-19-compatible radiological findings in chest CT, and being diagnosed with COVID-19

You may not qualify if:

  • Patients with negative SARS-CoV-2 PCR test, pneumonia on CT but not given Covid-19 treatment by not considering Covid-19 by their doctor will not be included.
  • Patients whose data are not available
  • Patients with poor CT image quality
  • Patients who were transferred to another hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, 34660, Turkey (Türkiye)

Location

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromePneumonia, Viral

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Elif Yıldırım Ayaz, M.D.

    Sultan Abdülhamid Han Training and Rsearch Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 9, 2021

Study Start

March 4, 2021

Primary Completion

May 6, 2021

Study Completion

May 6, 2021

Last Updated

June 9, 2021

Record last verified: 2021-06

Locations