NCT05650944

Brief Summary

It is aimed to reveal the treatment and prognostic values by evaluating the differences in hematological parameters and indices, especially in dead Covid-19 cases. Material Method: It is planned to retrospectively examine the hemogram parameters of 125 male, 44 female and 169 critical Covid-19 patients hospitalized between 01.03.2020 and 31.12.2021. Subjects were divided into 2 groups as deceased (77) and living (92) patients according to demographic data such as age and gender. Statistical evaluation: All analyzes were SPSS 25.0, Kolmogorov Smirnov test was used to determine distribution, median and interquartile range (Tukey's Hinges Percentile) were used to summarize variables. The differences between the Independent-Samples Mann Whitney U Test and the data of the patient groups and the optimal cut-off values, sensitivity and specificity values will be determined by ROC analysis. It will be considered statistically significant when the p value is below 0.05 (with the two-tailed test)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Typical duration 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

March 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

December 2, 2022

Last Update Submit

December 13, 2022

Conditions

Keywords

HemogramNLRMPV/PLTMPV/PCT

Outcome Measures

Primary Outcomes (1)

  • Hematological parameters in the prognosis of severe Covid-19 patients.

    Hemogram values of the deceased and surviving patients participating in the study were compared.

    2020-2021

Study Arms (2)

Covid-19 Survivor groups

Covid-19 survivor groups are hematological parameters

Diagnostic Test: Hemogram

Covid-19 Non-survivor groups

Hematological parameters in patients with severe COVID-19 who have died.

Diagnostic Test: Hemogram

Interventions

HemogramDIAGNOSTIC_TEST

Sysmex XN-1000 hematological analyzer

Covid-19 Non-survivor groupsCovid-19 Survivor groups

Eligibility Criteria

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

The study had 169 patients in all, including 44 women and 125 males

You may qualify if:

  • Patients over the age of 18
  • Critical patients taken to intensive care
  • The length of stay in the ICU is more than 24 hours

You may not qualify if:

  • \) Patients under 18 years of age (2) Patients with hematological malignancies (3) The length of stay in the ICU is less than 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisar Hospital Intercontinental

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ramazan Gozukucuk

    Istanbul Galata Universty

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 14, 2022

Study Start

March 1, 2020

Primary Completion

December 31, 2021

Study Completion

September 30, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

After accepted by Journal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Between 1 March 2020 and 31 December 2021
Access Criteria
All of result open accses.

Locations